Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03499353
• Collaborator: (none)
• Enrollment: 61
• Locations: 97
• Arm: 1
• Actual Duration (Months): 24.9
• Patients Per Site: 0.6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER

Condition or Disease	Intervention/Treatment	Phase
Early Breast Cancer	Drug: TALAZOPARIB	Phase 2

Detailed Description

TALAZOPARIB (PARP INHIBITOR) FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER. THIS IS A MONOTHERAPY TREATMENT FOR 24 WKS FOLLOWED BY SURGERY TO EVALUATE PATHOLOGICAL COMPLETE RESPONSE.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: THIS IS AN OPEN LABEL SINGLE ARM STUDYTHIS IS AN OPEN LABEL SINGLE ARM STUDY
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER
• Actual Study Start Date: Aug 27, 2018
• Actual Primary Completion Date: Sep 23, 2020
• Actual Study Completion Date: Sep 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TALAZOPARIB SINGLE ARM, NON-RANDOMIZED	Drug: TALAZOPARIB; Talazoparib 1mg/day

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving Pathological Complete Response (pCR) as Per Independent Central Review (ICR) in Evaluable Analysis Set as Per ICR With 80% Confidence Interval (CI) [Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)]

   pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current American Joint Committee on Cancer [AJCC] staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.

2. Percentage of Participants Achieving pCR as Per ICR in Evaluable Analysis Set as Per ICR With 95% CI [Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)]

   pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.

Secondary Outcome Measures

1. Percentage of Participants Achieving pCR as Per ICR in Intention-to-Treat (ITT) Analysis Set With 80% CI [Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)]

   pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.

2. Percentage of Participants Achieving pCR as Per ICR in ITT Analysis Set With 95% CI [Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)]

   pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.

3. Percentage of Participants Achieving pCR as Per Investigator in Evaluable Analysis Set as Per Investigator [Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)]

   pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by investigator was defined as the percentage of participants achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per Investigator). The exact CI was calculated using the Blaker's method.

4. Percentage of Participants Achieving pCR as Per Investigator in ITT Analysis Set [Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)]

   pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by investigator in ITT Analysis Set was defined as the percentage of participants achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.

5. Percentage of Participants Achieving pCR in Breast Only as Per Investigator in Evaluable Analysis Set as Per Investigator [Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)]

   pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by investigator was defined as the percentage of participants achieving pCR in breast by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per Investigator). The exact CI was calculated using the Blaker's method.

6. Percentage of Participants Achieving pCR in Breast Only as Per Investigator in ITT Analysis Set [Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)]

   pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by investigator in ITT Analysis Set was defined as the percentage of participants achieving pCR in breast by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.

7. Percentage of Participants Achieving pCR in Breast Only as Per ICR in Evaluable Analysis Set as Per ICR [Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)]

   pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by ICR was defined as the percentage of participants achieving pCR in breast by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.

8. Percentage of Participants Achieving pCR in Breast Only as Per ICR in ITT Analysis Set [Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)]

   pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR in breast by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.

9. Percentage of Participants With Residual Cander Burden (RCB) as Per ICR in Evaluable Analysis Set as Per ICR [Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)]

   The RCB is a continuous index derived from the following: primary tumor dimensions; cellularity of the tumor bed; axillary nodal burden. Residual cancer burden by ICR is reported as a categorical variable with four classes (categories): RCB 0 (pCR), I (minimal RCB), II (moderate RCB), III (extensive RCB). Participants who had progressive disease or was unable to be assessed for RCB due to missing required axillary specimen were counted in the "Missing" category. The simultaneous exact CI was calculated using Goodman's method.

10. Percentage of Participants With RCB as Per ICR in ITT Analysis Set [Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)]

    The RCB is a continuous index derived from the following: primary tumor dimensions; cellularity of the tumor bed; axillary nodal burden. Residual cancer burden by ICR is reported as a categorical variable with four classes (categories): RCB 0 (pCR), I (minimal RCB), II (moderate RCB), III (extensive RCB). Participants who had progressive disease or was unable to be assessed for RCB due to missing required axillary specimen were counted in the "Missing" category. The simultaneous exact CI was calculated using Goodman's method.

11. Probability of Being Event-Free at 3 Years in Evaluable Analysis Set [3 years after surgery]

    Event-Free Survival (EFS) is defined as the time from surgery date to first documentation of local or distant recurrence or death or initiation of antineoplastic therapy before documentation of first relapse. Participants discontinuing study before documentation of first relapse or death, but after surgery were censored observations for EFS. EFS at 3 years is defined as the probability of being event free at 3 years after surgery using Kaplan Meier methods.

12. Probability of Being Alive at 3 Years in Evaluable Analysis Set [3 years after first dose of talazoparib]

    Overall Survival (OS) is defined as the time from first dose of talazoparib to death due to any cause. Participants not known to have died at the time of the analysis were right censored on the date they were last known to be alive before the analysis data cutoff date. OS at 3 years is defined as the probability of being alive at 3 years after first dose of talazoparib using Kaplan Meier methods.

13. Probability of Being Alive at 3 Years in ITT Analysis Set [3 years after first dose of talazoparib]

    OS is defined as the time from first dose of talazoparib to death due to any cause. Participants not known to have died at the time of the analysis were right censored on the date they were last known to be alive before the analysis data cutoff date. OS at 3 years is defined as the probability of being alive at 3 years after first dose of talazoparib using Kaplan Meier methods.

14. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)]

    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or worsened relative to pretreatment state. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE.

15. Number of Participants With Serious Adverse Events (SAEs) [Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)]

    An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.

16. Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Drug [Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)]

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.

17. Number of Participants With TEAEs Leading to Temporary Discontinuation of Study Drug [Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)]

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.

18. Number of Participants With TEAEs Leading to Dose Reduction of Study Drug [Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)]

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.

19. Number of Participants With Laboratory Abnormalities [Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)]

    Laboratory parameters included hematology, serum chemistry, urinalysis and coagulation. Grades of laboratory abnormalities were defined according to NCI CTCAE version 4.03. Participants with laboratory test abnormalities meeting specified criteria (>upper limit of normal [ULN] or <lower limit of normal [LLN]) (without regards to baseline abnormality) are reported.

20. Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline [Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)]

    Hematology laboratory parameters included hematocrit, hemoglobin, mean corpuscular volume, red blood cells, platelets, white blood cells with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils). Grades of lab results were defined by NCI CTCAE version 4.03. Grade 1(mild)=asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2(moderate)=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE. This outcome measure was based only on laboratory data. As Grade 4 anemia cannot be assessed based only on laboratory data, it was not applicable for analysis in this outcome measure.

21. Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline [Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)]

    Chemistry laboratory parameters included albumin, total protein, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, creatinine, non-fasting glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and lactate dehydrogenase. Grades of laboratory results were defined by NCI CTCAE version 4.03. Grade 1 (Mild) = asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 (Moderate ) = minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4 = events with life-threatening consequences, urgent intervention indicated; Grade 5 = death related to AE.

22. Trough Plasma Concentration (Ctrough) of Talazoparib in Cycles 2, 3 and 4 in PK Analysis Set [Pre-dose on Day 1 of Cycles 2, 3, 4]

23. Within-Participant Average Ctrough of Talazoparib at Steady State in PK Analysis Set [Pre-dose on Day 1 of Cycles 2, 3, 4]

    Within-participant average Ctrough of talazoparib at steady state for each participant was defined as the average (mean) value of the steady state Ctrough values (Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1 trough concentrations) for each individual participant.

24. Ctrough of Talazoparib in Cycles 2, 3 and 4 in Dose-Compliant PK Analysis Set [Pre-dose on Day 1 of Cycles 2, 3, 4]

25. Within-Participant Average Ctrough of Talazoparib at Steady State in Dose-Compliant PK Analysis Set [Pre-dosing on Day 1 of Cycles 2, 3, 4]

    Within-participant average Ctrough of talazoparib at steady state for each participant was defined as the average (mean) value of the steady state Ctrough values (Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1 trough concentrations) for each individual participant.

26. Number of Participants Who Achieved Definitive Deterioration in Global Health Status (GHS)/Quality of Life (QoL) Per European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-30) [Baseline to End of Treatment visit (assessed for maximum of 33 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes (PROs), consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent <10 point decrease.

27. Kaplan-Meier Estimate of Time to Definitive Deterioration in GHS/QoL Per EORTC QLQ-30 [Baseline to End of Treatment visit (assessed for maximum of 33 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent <10 point decrease.

28. Probability of Not Achieving Definitive Deterioration in GHS/QoL Per EORTC QLQ-C30 at 3 and 6 Months [3 months and 6 months post-baseline]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all to 4=very much). For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent <10 point decrease. Probability of not achieving definitive deterioration (being event-free) at specified time points (3 and 6 months post-baseline) using the Kaplan Meier method were reported.

29. Number of Participants Who Achieved Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 [Baseline to End of Treatment visit (assessed for maximum of 33 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point increase from baseline without any subsequent <10 point increase.

30. Kaplan-Meier Estimate of Time to Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 [Baseline to End of Treatment visit (assessed for maximum of 33 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point increase from baseline without any subsequent <10 point increase.

31. Probability of Not Achieving Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 at 3 and 6 Months [3 months and 6 months post-baseline]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, with 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores (1=very poor to 7=excellent); other items have 4 possible scores (1=not at all to 4=very much). For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A linear transformation was applied to raw scores so that transformed scores lie between 0 to 100, with 0 being the best and 100 being the worst for this symptom scale. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as≥10 point increase from baseline without any subsequent <10 point increase. Probability of not achieving definitive deterioration (being event-free) at specified time points (3 and 6 months post-baseline) using Kaplan Meier method were reported.

32. Change From Baseline in Global QoL Per EORTC QLQ-C30 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. Negative change from baseline indicates deterioration in GHS/QoL and positive change indicates improvement.

33. Change From Baseline in Physical Functioning Per EORTC QLQ-C30 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the physical functioning scale, participants self-rated levels of difficulty in doing strenuous activities, taking a walk, how much they needed to stay in bed or a chair, or needed help with eating, dressing, bathing, using the toilet. Negative change from baseline indicates deterioration in physical functioning and positive change indicates improvement.

34. Change From Baseline in Role Functioning Per EORTC QLQ-C30 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the role functioning scale, participants self-rated how much they were limited in doing work or daily activities, or in pursuing hobbies or other leisure time activities during the past week. Negative change from baseline values indicates deterioration in role functioning and positive change indicates improvement.

35. Change From Baseline in Emotional Functioning Per EORTC QLQ-C30 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the emotional functioning scale, participants self-rated how much they felt tense, worried, irritable or depressed during the past week. Negative change from baseline values indicates deterioration in emotional functioning and positive change indicates improvement.

36. Change From Baseline in Cognitive Functioning Per EORTC QLQ-C30 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the cognitive functioning scale, participants self-rated the extent of difficulty in concentrating on things or remembering things during the past week. Negative change from baseline values indicates deterioration in cognitive functioning and positive change indicates improvement.

37. Change From Baseline in Social Functioning Per EORTC QLQ-C30 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the social functioning scale, participants self-rated how much their physical condition or medical treatment interfered with their family life and social activities during the past week. Negative change from baseline values indicates deterioration in social functioning and positive change indicates improvement.

38. Change From Baseline in Fatigue Symptoms Per EORTC QLQ-C30 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the fatigue symptoms scale, participants self-rated how much they had felt weak, tired or needed to rest during the past week. Negative change from baseline values indicates improvement of fatigue symptoms and positive change indicates deterioration.

39. Change From Baseline in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. Negative change from baseline values indicates improvement of nausea and vomiting symptoms and positive change indicates deterioration.

40. Change From Baseline in Pain Symptoms Per EORTC QLQ-C30 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the pain symptoms scale, participants self-rated the extent of pain and how much the pain interfered with daily activities during the past week. Negative change from baseline values indicates improvement of pain symptoms and positive change indicates deterioration.

41. Change From Baseline in Dyspnoea Symptoms Per EORTC QLQ-C30 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the dyspnoea symptoms scale, participants self-rated the intensity of shortness of breath during the past week. Negative change from baseline values indicates improvement of dyspnoea symptoms and positive change indicates deterioration.

42. Change From Baseline in Insomnia Symptoms Per EORTC QLQ-C30 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the insomnia symptoms scale, participants self-rated the intensity of shortness of breath during the past week. Negative change from baseline values indicates improvement of insomnia symptoms and positive change indicates deterioration.

43. Change From Baseline in Appetite Loss Symptoms Per EORTC QLQ-C30 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the appetite loss symptoms scale, participants self-rated the extent of lack of appetite during the past week. Negative change from baseline values indicates improvement of appetite loss symptoms and positive change indicates deterioration.

44. Change From Baseline in Constipation Symptoms Per EORTC QLQ-C30 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the constipation symptoms scale, participants self-rated the intensity of constipation during the past week. Negative change from baseline values indicates improvement of constipation symptoms and positive change indicates deterioration.

45. Change From Baseline in Diarrhea Symptoms Per EORTC QLQ-C30 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the diarrhea symptoms scale, participants self-rated the intensity of diarrhea during the past week. Negative change from baseline values indicates improvement of diarrhea symptoms and positive change indicates deterioration.

46. Change From Baseline in Financial Difficulties Per EORTC QLQ-C30 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the symptom scale of financial difficulties, participants self-rated how much their physical condition or medical treatment caused financial difficulties. Negative change from baseline values indicates improvement of financial difficulties and positive change indicates deterioration.

47. Change From Baseline in Body Image Per EORTC QLQ Breast Cancer Quality of Life Questionnaire (EORTC QLQ-BR23) [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of body image, participants self-rated how much they felt physically less attractive or less feminine, difficult to look at themselves naked, or dissatisfied with their body during the past week. Negative change from baseline indicates worsening of self-rated body image and positive change indicates improvement.

48. Change From Baseline in Sexual Functioning Per EORTC QLQ-BR23 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the sexual functioning scale, participants self-rated to what extent they were interested in sex and were sexually active (with or without intercourse) during the past 4 weeks. Negative change from baseline values indicates worsening of sexual functioning and positive change indicates improvement.

49. Change From Baseline in Sexual Enjoyment Per EORTC QLQ-BR23 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of sexual enjoyment, participants self-rated to what extent sex was enjoyable for them during the past 4 weeks. Negative change from baseline values indicates worsening of sexual enjoyment and positive change indicates improvement.

50. Change From Baseline in Future Perspective Per EORTC QLQ-BR23 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of future perspective, participants self-rated how much they were worried about their health in the future. Negative change from baseline values indicates worsening of future perspective and positive change indicates improvement.

51. Change From Baseline in Systemic Therapy Side Effects Per EORTC QLQ-BR23 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the systemic therapy side effects scale, participants self-rated the intensity of symptoms of dry mouth, unusual taste, pain and irritation of eyes, hair loss, feeling ill or unwell, hot flushes and headaches during the past week. Negative change from baseline= improvement of these side effects, positive change = deterioration.

52. Change From Baseline in Breast Symptoms Per EORTC QLQ-BR23 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the breast symptoms scale, participants self-rated how much they had pain or skin problems (e.g. itchy, dry, flaky) on or in the area of affected breast, and how much this area was swollen or oversensitive during the past week. Negative change from baseline indicates improvement of breast symptoms and positive change indicates deterioration.

53. Change From Baseline in Arm Symptoms Per EORTC QLQ-BR23 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the arm symptoms scale, participants self-rated how much they had pain in the arm or shoulder, how much the arm or hand was swollen, and difficulty in raising the arm or moving it sideways. Negative change from baseline indicates improvement of arm symptoms and positive change indicates deterioration.

54. Change From Baseline in Upset by Hair Loss Per EORTC QLQ-BR23 [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the upset by hair loss scale, participants self-rated how upset they were due to loss of hair during the past week. Negative change from baseline values indicates improvement of upset by hair loss and positive change indicates deterioration.

55. Number of Participants With Deterioration in Nausea/Vomiting Symptoms [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Deterioration in nausea and vomiting symptoms was defined as a 10 point or more increase from baseline for that specific time point.

56. Number of Participants With Improvement in Nausea/Vomiting Symptoms [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Improvement in nausea and vomiting symptoms was defined as a 10 point or more decrease from baseline for that specific time point.

57. Number of Participants With No Change in Nausea/Vomiting Symptoms [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all to 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. No change in nausea/vomiting symptoms=having neither deterioration (≥10 point increase from baseline) nor improvement (≥10 point decrease from baseline) for the time point.

58. Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)]

    Missed expected menstrual period was assessed electronically using the PRO CTCAE questionnaire, a PRO measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials. This objective captures the concept of fertility preservation through PRO, since there is a possible fertility sparing effect of talazoparib versus chemotherapy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Germline BRCA 1/2 Mutation Positive

• Women and men at least 18 years of age or older.

• Histologically confirmed invasive adenocarcinoma of the breast

• HER2 negative breast cancer as defined by ASCO-CAP criteria

• Tumor greater than or equal toT1, N0-3

• No evidence of distant metastasis

• Adequate bone marrow, hepatic, and renal function

• ECOG performance status 0 or 1

Exclusion Criteria:

• Any other previous antitumor therapies for the current cancer event. Treatment for ductal carcinoma in situ (DCIS) is allowed; ie, surgery, hormonal therapy and radiation.

• Evidence of distant metastasis apparent prior to randomization

• Patients with inflammatory breast carcinoma

• Malignancy within the last 3 years, except: Stage 1 melanoma which does not require any further treatment after adequate surgical excision; adequately treated non melanoma skin cancer; Curatively treated in situ cancer of the cervix; Stage 1, Grade 1 endometrial carcinoma; or Adequately treated contralateral breast carcinoma which has been disease free for a year; Other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for 5 years.

• Previous or concomitant systemic anti cancer therapies used for the treatment of cancer in the last 3 years.

• Prior treatment with a PARP inhibitor in any disease setting

• Concomitant use of Strong P gp inhibitors or inducers or BCRP inhibitors

• Patients who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol

• Major surgery within 14 days prior to study entry

• Known history of cardiac disease, for example : Myocardial infarction or symptomatic cardiac ischemia within 24 weeks before screening; Congestive heart failure New York Heart Association Class III or IV; History of clinically significant ventricular arrhythmias within one year prior to randomization; History of Mobitz II second degree or third degree heart block, uncontrolled hypertension.

• Active clinically significant infection

• Clinically significant bleeding diathesis or coagulopathy

• Non healing wound, ulcer or bone fracture

• Known hypersensitivity to any of the components of talazoparib

• Patients with myelodysplastic syndrome/acute myeloid leukemia

• Patients with uncontrolled seizures.

• Any evidence of other disease or any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner Gateway Medical Center	Gilbert	Arizona	United States	85234
2	Banner MD Anderson Cancer Center	Gilbert	Arizona	United States	85234
3	Highlands Oncology Group	Fayetteville	Arkansas	United States	72703
4	Highlands Oncology Group	Rogers	Arkansas	United States	72758
5	PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists	Camarillo	California	United States	93010
6	City of Hope (City of Hope National Medical Center, City of Hope Medical Center)	Duarte	California	United States	91010
7	City of Hope Investigational Drug Services (IDS)	Duarte	California	United States	91010
8	The Oncology Institute of Hope & Innovation	Glendale	California	United States	91204
9	Glendale Adventist Medical Center	Glendale	California	United States	91206
10	The Oncology Institute of Hope & Innovation	Long Beach	California	United States	90805
11	UC Irvine Health	Orange	California	United States	92868-3201
12	UC Irvine Medical Center	Orange	California	United States	92868-3201
13	PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists	Oxnard	California	United States	93030
14	Emad Ibrahim, MD, INC.	Redlands	California	United States	92373
15	The Oncology Institute of Hope & Innovation	Santa Ana	California	United States	92705
16	Stanford Cancer Institute	Stanford	California	United States	94305
17	Stanford Hospital and Clinics	Stanford	California	United States	94305
18	Stanford Women's Cancer Center	Stanford	California	United States	94305
19	PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists	Ventura	California	United States	93003
20	The Oncology Institute of Hope & Innovation	West Covina	California	United States	91790
21	The Oncology Institute of Hope & Innovation	Whittier	California	United States	90602
22	ICRI	Whittier	California	United States	90603
23	Rocky Mountain Cancer Centers	Aurora	Colorado	United States	80012
24	Rocky Mountain Cancer Centers	Boulder	Colorado	United States	80303
25	Rocky Mountain Cancer Centers	Colorado Springs	Colorado	United States	80907
26	Rocky Mountain Cancer Centers	Denver	Colorado	United States	80218
27	Rocky Mountain Cancer Centers	Denver	Colorado	United States	80220
28	Rocky Mountain Cancer Centers	Englewood	Colorado	United States	80113
29	Rocky Mountain Cancer Centers	Lakewood	Colorado	United States	80228
30	Rocky Mountain Cancer Centers	Littleton	Colorado	United States	80120-4413
31	Rocky Mountain Cancer Centers	Lone Tree	Colorado	United States	80124
32	Rocky Mountain Cancer Centers	Longmont	Colorado	United States	80501
33	Rocky Mountain Cancer Centers	Parker	Colorado	United States	80138
34	Rocky Mountain Cancer Centers	Pueblo	Colorado	United States	81008
35	Rocky Mountain Cancer Centers	Thornton	Colorado	United States	80260
36	Innovative Medical Research of South Florida, Inc	Aventura	Florida	United States	33180
37	Grady Health System	Atlanta	Georgia	United States	30303
38	Emory University Hospital Midtown	Atlanta	Georgia	United States	30308
39	Emory University Hospital	Atlanta	Georgia	United States	30322
40	The Emory Clinic	Atlanta	Georgia	United States	30322
41	Winship Cancer Institute	Atlanta	Georgia	United States	30322
42	Emory Saint Joseph's Hospital	Atlanta	Georgia	United States	30342
43	Rush University Medical Center, Professional Office Building Infusion Pharmacy	Chicago	Illinois	United States	60612
44	Rush University Medical Center	Chicago	Illinois	United States	60612
45	Rush Oak Park Hospital	Oak Park	Illinois	United States	60304
46	University of Mississippi Medical Center	Jackson	Mississippi	United States	39213
47	Summit Medical Group	Berkeley Heights	New Jersey	United States	07922
48	Summit Medical Group PA	Florham Park	New Jersey	United States	07932
49	St. Luke's Hospital - Warren Campus	Phillipsburg	New Jersey	United States	08865
50	St. Luke's Warren Physician Group	Phillipsburg	New Jersey	United States	08865
51	Northwest Cancer Specialists, P.C.	Portland	Oregon	United States	97213-2982
52	Northwest Cancer Specialists, P.C.	Portland	Oregon	United States	97227
53	Northwest Cancer Specialists, P.C.	Tigard	Oregon	United States	97223
54	St. Luke's Hematology Oncology Specialists	Allentown	Pennsylvania	United States	18104
55	St. Luke's Hospital - Allentown Campus	Allentown	Pennsylvania	United States	18104
56	St. Luke's Hematology Oncology Specialists	Bethlehem	Pennsylvania	United States	18015
57	St. Luke's Hospital - Bethlehem Campus	Bethlehem	Pennsylvania	United States	18015
58	St. Luke's Hospital - Miners Campus	Coaldale	Pennsylvania	United States	18218
59	St Luke's Hospital - Anderson Campus	Easton	Pennsylvania	United States	18045
60	St. Luke's Hospital - Anderson Campus	Easton	Pennsylvania	United States	18045
61	UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion	Greensburg	Pennsylvania	United States	15601
62	UPMC Cancer Centers East Oxford Drive	Monroeville	Pennsylvania	United States	15146
63	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania	United States	15213
64	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	United States	15232
65	UPMC Hillman Cancer Center North Hills at Passavant	Pittsburgh	Pennsylvania	United States	15237
66	UPMC Hillman Cancer Center UPMC Passavant	Pittsburgh	Pennsylvania	United States	15237
67	St. Luke's Hospital - Quakertown Campus	Quakertown	Pennsylvania	United States	18951
68	St. Luke's Hospital - Monroe Campus	Stroudsburg	Pennsylvania	United States	18360
69	UPMC Hillman Cancer Center Uniontown	Uniontown	Pennsylvania	United States	15401
70	UPMC Hillman Cancer Center Washington	Washington	Pennsylvania	United States	15301
71	Charleston Hematology Oncology Associates, PA	Charleston	South Carolina	United States	29414
72	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
73	Avera Specialty Hospital	Sioux Falls	South Dakota	United States	57108
74	Brig Center for Cancer Care and Survivorship	Knoxville	Tennessee	United States	37909
75	Baptist Cancer Center	Memphis	Tennessee	United States	38120
76	Texas Oncology - Allen	Allen	Texas	United States	75013
77	Texas Oncology - Austin Midtown	Austin	Texas	United States	78705
78	Texas Oncology-Austin Central	Austin	Texas	United States	78731
79	Texas Oncology - South Austin	Austin	Texas	United States	78745
80	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas	United States	75246
81	Texas Oncology-Denton South	Denton	Texas	United States	76210
82	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030-4009
83	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
84	U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376	Houston	Texas	United States	77030
85	U.T. MD Anderson Cancer Center	Houston	Texas	United States	77030
86	US Oncology Investigational Products Center (IPC)	Irving	Texas	United States	75063
87	Texas Oncology - McKinney	McKinney	Texas	United States	75071
88	Texas Oncology - Round Rock	Round Rock	Texas	United States	78681
89	Virginia Oncology Associates	Chesapeake	Virginia	United States	23320
90	Virginia Oncology Associates	Hampton	Virginia	United States	23666
91	Virginia Oncology Associates	Newport News	Virginia	United States	23606
92	Virginia Oncology Associates	Norfolk	Virginia	United States	23502
93	Virginia Oncology Associates	Virginia Beach	Virginia	United States	23456
94	Northwest Cancer Specialists, P.C.	Vancouver	Washington	United States	98683
95	Northwest Cancer Specialists, P.C.	Vancouver	Washington	United States	98684
96	University of Wisconsin Clinical Science Center	Madison	Wisconsin	United States	53792
97	UW Health University Hospital - Pharmaceutical Research Center	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Aug 14, 2019
• Statistical Analysis Plan - Feb 26, 2020

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03499353
• Other Study ID Numbers: C3441020; TALAZOPARIB NEOADJ BC
• First Posted: Apr 17, 2018
• Last Update Posted: Nov 9, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: Neoadjuvant Therapy, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE Breast Cancer, BRCA Positive
• Additional relevant MeSH terms: Breast Neoplasms; Talazoparib

Study Results

Participant Flow

Pre-assignment Detail	A total of 61 participants were enrolled and treated with talazoparib.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Period Title: Treatment
STARTED	61
COMPLETED	45
NOT COMPLETED	16
Period Title: Treatment
STARTED	49
Received Treatment	0
COMPLETED	49
NOT COMPLETED	0
Period Title: Treatment
STARTED	58
Received Treatment	0
COMPLETED	0
NOT COMPLETED	58

Baseline Characteristics

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Overall Participants	61
Age (Years) [Mean (Standard Deviation) ]
Mean	44.6 (12.7)
Age, Customized (Count of Participants)
18-44 Years	37 60.7%
45-64 Years	18 29.5%
>=65 Years	6 9.8%
Sex: Female, Male (Count of Participants)
Female	61 100%
Male	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	47 77%
Black or African American	7 11.5%
Asian	3 4.9%
Not reported	4 6.6%
Race/Ethnicity, Customized (Count of Participants)
Chinese	1 1.6%
African American	7 11.5%
Ashkenazi Jew	1 1.6%
Other	49 80.3%
Not reported	3 4.9%
Number of Participants with Triple Negative Breast Cancer (TNBC) at Baseline (Count of Participants)
Count of Participants [Participants]	61 100%
Duration of Breast Cancer at Baseline (Weeks) [Median (Full Range) ]
Median (Full Range) [Weeks]	3.57
Number of Participants with Breast Cancer Gene 1/2 (BRCA1/2) Mutations at Baseline (Count of Participants)
BRCA1	48 78.7%
BRCA2	13 21.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Pathological Complete Response (pCR) as Per Independent Central Review (ICR) in Evaluable Analysis Set as Per ICR With 80% Confidence Interval (CI)
Description	pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current American Joint Committee on Cancer [AJCC] staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.
Time Frame	Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants enrolled who received at least 80% of the dose of talazoparib prescribed at treatment start (1 mg/day, with the exception of participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by ICR, as well as participants who progressed or died before pCR could be assessed by ICR (these participants were considered as non-responders).

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	48
Number (80% Confidence Interval) [Percentage of participants]	45.8 75.1%

2. Primary Outcome

Title	Percentage of Participants Achieving pCR as Per ICR in Evaluable Analysis Set as Per ICR With 95% CI
Description	pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.
Time Frame	Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants enrolled who received at least 80% of the dose of talazoparib prescribed at treatment start (1 mg/day, with the exception of participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by ICR, as well as participants who progressed or died before pCR could be assessed by ICR (these participants were considered as non-responders).

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	48
Number (95% Confidence Interval) [Percentage of participants]	45.8 75.1%

3. Secondary Outcome

Title	Percentage of Participants Achieving pCR as Per ICR in Intention-to-Treat (ITT) Analysis Set With 80% CI
Description	pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
Time Frame	Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received any amount of talazoparib.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
Number (80% Confidence Interval) [Percentage of participants]	49.2 80.7%

4. Secondary Outcome

Title	Percentage of Participants Achieving pCR as Per ICR in ITT Analysis Set With 95% CI
Description	pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
Time Frame	Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received any amount of talazoparib.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
Number (95% Confidence Interval) [Percentage of participants]	49.2 80.7%

5. Secondary Outcome

Title	Percentage of Participants Achieving pCR as Per Investigator in Evaluable Analysis Set as Per Investigator
Description	pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by investigator was defined as the percentage of participants achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per Investigator). The exact CI was calculated using the Blaker's method.
Time Frame	Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants enrolled who received at least 80% of the talazoparib dose prescribed at treatment start (1 mg/day, except participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by investigator, as well as participants who progressed or died before pCR could be assessed by investigator (these participants were considered as non-responders).

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	48
Number (95% Confidence Interval) [Percentage of participants]	45.8 75.1%

6. Secondary Outcome

Title	Percentage of Participants Achieving pCR as Per Investigator in ITT Analysis Set
Description	pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by investigator in ITT Analysis Set was defined as the percentage of participants achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
Time Frame	Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received any amount of talazoparib.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
Number (95% Confidence Interval) [Percentage of participants]	47.5 77.9%

7. Secondary Outcome

Title	Percentage of Participants Achieving pCR in Breast Only as Per Investigator in Evaluable Analysis Set as Per Investigator
Description	pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by investigator was defined as the percentage of participants achieving pCR in breast by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per Investigator). The exact CI was calculated using the Blaker's method.
Time Frame	Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants enrolled who received at least 80% of the talazoparib dose prescribed at treatment start (1 mg/day, except participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by investigator, as well as participants who progressed or died before pCR could be assessed by investigator (these participants were considered as non-responders).

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	48
Number (95% Confidence Interval) [Percentage of participants]	45.8 75.1%

8. Secondary Outcome

Title	Percentage of Participants Achieving pCR in Breast Only as Per Investigator in ITT Analysis Set
Description	pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by investigator in ITT Analysis Set was defined as the percentage of participants achieving pCR in breast by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
Time Frame	Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received any amount of talazoparib.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
Number (95% Confidence Interval) [Percentage of participants]	47.5 77.9%

9. Secondary Outcome

Title	Percentage of Participants Achieving pCR in Breast Only as Per ICR in Evaluable Analysis Set as Per ICR
Description	pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by ICR was defined as the percentage of participants achieving pCR in breast by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.
Time Frame	Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants enrolled who received at least 80% of the dose of talazoparib prescribed at treatment start (1 mg/day, with the exception of participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by ICR, as well as participants who progressed or died before pCR could be assessed by ICR (these participants were considered as non-responders).

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	48
Number (95% Confidence Interval) [Percentage of participants]	47.9 78.5%

10. Secondary Outcome

Title	Percentage of Participants Achieving pCR in Breast Only as Per ICR in ITT Analysis Set
Description	pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR in breast by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
Time Frame	Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received any amount of talazoparib.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
Number (95% Confidence Interval) [Percentage of participants]	50.8 83.3%

11. Secondary Outcome

Title	Percentage of Participants With Residual Cander Burden (RCB) as Per ICR in Evaluable Analysis Set as Per ICR
Description	The RCB is a continuous index derived from the following: primary tumor dimensions; cellularity of the tumor bed; axillary nodal burden. Residual cancer burden by ICR is reported as a categorical variable with four classes (categories): RCB 0 (pCR), I (minimal RCB), II (moderate RCB), III (extensive RCB). Participants who had progressive disease or was unable to be assessed for RCB due to missing required axillary specimen were counted in the "Missing" category. The simultaneous exact CI was calculated using Goodman's method.
Time Frame	Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants enrolled who received at least 80% of the dose of talazoparib prescribed at treatment start (1 mg/day, with the exception of participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by ICR, as well as participants who progressed or died before pCR could be assessed by ICR (these participants were considered as non-responders).

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	48
RCB - 0	45.8 75.1%
RCB - I	0.0 0%
RCB - II	31.3 51.3%
RCB - III	0.0 0%
Missing (Participants who had progressive disease or with missing required axillary specimen)	22.9 37.5%

12. Secondary Outcome

Title	Percentage of Participants With RCB as Per ICR in ITT Analysis Set
Description	The RCB is a continuous index derived from the following: primary tumor dimensions; cellularity of the tumor bed; axillary nodal burden. Residual cancer burden by ICR is reported as a categorical variable with four classes (categories): RCB 0 (pCR), I (minimal RCB), II (moderate RCB), III (extensive RCB). Participants who had progressive disease or was unable to be assessed for RCB due to missing required axillary specimen were counted in the "Missing" category. The simultaneous exact CI was calculated using Goodman's method.
Time Frame	Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received any amount of talazoparib

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
RCB - 0	49.2 80.7%
RCB - I	1.6 2.6%
RCB - II	27.9 45.7%
RCB - III	0.0 0%
Missing (Participants who had progressive disease or with missing required axillary specimen)	21.3 34.9%

13. Secondary Outcome

Title	Probability of Being Event-Free at 3 Years in Evaluable Analysis Set
Description	Event-Free Survival (EFS) is defined as the time from surgery date to first documentation of local or distant recurrence or death or initiation of antineoplastic therapy before documentation of first relapse. Participants discontinuing study before documentation of first relapse or death, but after surgery were censored observations for EFS. EFS at 3 years is defined as the probability of being event free at 3 years after surgery using Kaplan Meier methods.
Time Frame	3 years after surgery

Outcome Measure Data

Analysis Population Description

The analysis population included all participants enrolled who received at least 80% of the dose prescribed at treatment start (1 mg/day, except those with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment, and participants who progressed or died before pCR could be assessed. EFS at 3 years was not analyzed as the 3-year threshold was not reached at study termination, therefore number of participants analyzed was 0.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	0

14. Secondary Outcome

Title	Probability of Being Alive at 3 Years in Evaluable Analysis Set
Description	Overall Survival (OS) is defined as the time from first dose of talazoparib to death due to any cause. Participants not known to have died at the time of the analysis were right censored on the date they were last known to be alive before the analysis data cutoff date. OS at 3 years is defined as the probability of being alive at 3 years after first dose of talazoparib using Kaplan Meier methods.
Time Frame	3 years after first dose of talazoparib

Outcome Measure Data

Analysis Population Description

The analysis population included all participants enrolled who received at least 80% of the dose prescribed at treatment start (1 mg/day, except those with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment, and participants who progressed or died before pCR could be assessed. OS at 3 years was not analyzed as the 3-year threshold was not reached at study termination, therefore number of participants analyzed was 0.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	0

15. Secondary Outcome

Title	Probability of Being Alive at 3 Years in ITT Analysis Set
Description	OS is defined as the time from first dose of talazoparib to death due to any cause. Participants not known to have died at the time of the analysis were right censored on the date they were last known to be alive before the analysis data cutoff date. OS at 3 years is defined as the probability of being alive at 3 years after first dose of talazoparib using Kaplan Meier methods.
Time Frame	3 years after first dose of talazoparib

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received any amount of talazoparib. OS at 3 years was not analyzed as no participants had yet reached the 3-year threshold when the study was terminated, therefore the number of participants analyzed for this outcome measure was 0.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	0

16. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or worsened relative to pretreatment state. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE.
Time Frame	Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received any amount of talazoparib.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
All-causality TEAEs	60 98.4%
All-causality Grade 3 or 4 TEAEs	29 47.5%
All-causality Grade 5 TEAEs	0 0%
Treatment-related TEAEs	58 95.1%
Treatment-related Grade 3 or 4 TEAEs	27 44.3%
Treatment-related Grade 5 TEAEs	0 0%

17. Secondary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs)
Description	An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.
Time Frame	Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received any amount of talazoparib.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
All-causality SAEs	11 18%
Treatment-related SAEs	9 14.8%

18. Secondary Outcome

Title	Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Drug
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame	Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received any amount of talazoparib.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
All-causality TEAEs	3 4.9%
Treatment-related TEAEs	3 4.9%

19. Secondary Outcome

Title	Number of Participants With TEAEs Leading to Temporary Discontinuation of Study Drug
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame	Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received any amount of talazoparib.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
All-causality TEAEs	20 32.8%
Treatment-related TEAEs	19 31.1%

20. Secondary Outcome

Title	Number of Participants With TEAEs Leading to Dose Reduction of Study Drug
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame	Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received any amount of talazoparib.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
All-causality TEAEs	24 39.3%
Treatment-related TEAEs	24 39.3%

21. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities
Description	Laboratory parameters included hematology, serum chemistry, urinalysis and coagulation. Grades of laboratory abnormalities were defined according to NCI CTCAE version 4.03. Participants with laboratory test abnormalities meeting specified criteria (>upper limit of normal [ULN] or <lower limit of normal [LLN]) (without regards to baseline abnormality) are reported.
Time Frame	Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received any amount of talazoparib. Number of participants analyzed refers to number of participants evaluable for this outcome measure. Number analyzed refers to total number of participants with at least 1 observation of the given laboratory test.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
Erythrocyte Mean Corpuscular Volume <LLN	1 1.6%
Erythrocyte Mean Corpuscular Volume >ULN	33 54.1%
Erythrocytes <LLN	38 62.3%
Hematocrit <LLN	39 63.9%
Blood urea nitrogen >ULN	3 4.9%
Lactate dehydrogenase >ULN	8 13.1%
Protein <LLN	5 8.2%
Protein >ULN	2 3.3%
Prothrombin Time <LLN	2 3.3%

22. Secondary Outcome

Title	Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline
Description	Hematology laboratory parameters included hematocrit, hemoglobin, mean corpuscular volume, red blood cells, platelets, white blood cells with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils). Grades of lab results were defined by NCI CTCAE version 4.03. Grade 1(mild)=asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2(moderate)=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE. This outcome measure was based only on laboratory data. As Grade 4 anemia cannot be assessed based only on laboratory data, it was not applicable for analysis in this outcome measure.
Time Frame	Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received any amount of talazoparib. Number of participants analyzed refers to number of participants evaluable for this outcome measure. Number analyzed refers to total number of participants who had on-study laboratory test values that were applicable for the assessment of the laboratory results of interest.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
Anemia Grade 0 to Grade 3	7 11.5%
Anemia Grade 1 to Grade 3	1 1.6%
Anemia Grade 2 to Grade 3	0 0%
Lymphocyte count decreased Grade 0 to Grade 3	1 1.6%
Lymphocyte count decreased Grade 1 to Grade 3	0 0%
Lymphocyte count decreased Grade 2 to Grade 3	0 0%
Lymphocyte count decreased Grade 0 to Grade 4	0 0%
Lymphocyte count decreased Grade 1 to Grade 4	0 0%
Lymphocyte count decreased Grade 2 to Grade 4	0 0%
Neutrophil count decreased Grade 0 to Grade 3	3 4.9%
Neutrophil count decreased Grade 0 to Grade 4	0 0%
Neutrophil count decreased Grade 1 to Grade 3	0 0%
Neutrophil count decreased Grade 1 to Grade 4	0 0%
Neutrophil count decreased Grade 2 to Grade 3	0 0%
Neutrophil count decreased Grade 2 to Grade 4	0 0%
White blood cell decreased Grade 0 to Grade 3	1 1.6%
White blood cell decreased Grade 0 to Grade 4	0 0%
White blood cell decreased Grade 1 to Grade 3	0 0%
White blood cell decreased Grade 1 to Grade 4	0 0%
White blood cell decreased Grade 2 to Grade 3	0 0%
White blood cell decreased Grade 2 to Grade 4	0 0%

23. Secondary Outcome

Title	Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline
Description	Chemistry laboratory parameters included albumin, total protein, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, creatinine, non-fasting glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and lactate dehydrogenase. Grades of laboratory results were defined by NCI CTCAE version 4.03. Grade 1 (Mild) = asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 (Moderate ) = minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4 = events with life-threatening consequences, urgent intervention indicated; Grade 5 = death related to AE.
Time Frame	Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received any amount of talazoparib.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
Hyperglycemia Baseline grade not reported to Grade 3	0 0%
Hyperglycemia Baseline grade not reported to Grade 4	0 0%
Hyperglycemia Grade 0 to Grade 3	1 1.6%
Hyperglycemia Grade 0 to Grade 4	0 0%
Hyperglycemia Grade 1 to Grade 3	0 0%
Hyperglycemia Grade 1 to Grade 4	0 0%
Hyperglycemia Grade 2 to Grade 3	0 0%
Hyperglycemia Grade 2 to Grade 4	0 0%
Hypophosphatemia Baseline grade not reported to Grade 3	0 0%
Hypophosphatemia Baseline grade not reported to Grade 4	0 0%
Hypophosphatemia Grade 0 to Grade 3	1 1.6%
Hypophosphatemia Grade 0 to Grade 4	0 0%
Hypophosphatemia Grade 1 to Grade 3	0 0%
Hypophosphatemia Grade 1 to Grade 4	0 0%
Hypophosphatemia Grade 2 to Grade 3	0 0%
Hypophosphatemia Grade 2 to Grade 4	0 0%

24. Secondary Outcome

Title	Trough Plasma Concentration (Ctrough) of Talazoparib in Cycles 2, 3 and 4 in PK Analysis Set
Time Frame	Pre-dose on Day 1 of Cycles 2, 3, 4

Outcome Measure Data

Analysis Population Description

The analysis population included all participants treated with talazoparib with drug plasma concentration results from at least 1 visit. Number of participants analyzed=number of participants evaluable for this outcome measure. Number analyzed=number of participants evaluable for each time point.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
Cycle 2	4703 (71.5)
Cycle 3	4699 (119.9)
Cycle 4	4198 (139.8)

25. Secondary Outcome

Title	Within-Participant Average Ctrough of Talazoparib at Steady State in PK Analysis Set
Description	Within-participant average Ctrough of talazoparib at steady state for each participant was defined as the average (mean) value of the steady state Ctrough values (Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1 trough concentrations) for each individual participant.
Time Frame	Pre-dose on Day 1 of Cycles 2, 3, 4

Outcome Measure Data

Analysis Population Description

The analysis population included all participants treated with talazoparib for whom drug plasma concentration results from at least 1 visit were available.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	61
Geometric Mean (Geometric Coefficient of Variation) [pg/mL]	4525 (109.5)

26. Secondary Outcome

Title	Ctrough of Talazoparib in Cycles 2, 3 and 4 in Dose-Compliant PK Analysis Set
Time Frame	Pre-dose on Day 1 of Cycles 2, 3, 4

Outcome Measure Data

Analysis Population Description

The analysis population included all participants treated with talazoparib with drug plasma concentration results from at least 1 visit who had received 21 consecutive days of dosing without interruption prior to sample collection. Actual sample collection times were used to determine whether a pre-dose PK sample was dose-compliant. Number of participants analyzed=number of participants evaluable for this outcome measure. Number analyzed=number of participants evaluable for each time point.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	51
Cycle 2	5241 (57.9)
Cycle 3	5208 (53.8)
Cycle 4	4537 (84.6)

27. Secondary Outcome

Title	Within-Participant Average Ctrough of Talazoparib at Steady State in Dose-Compliant PK Analysis Set
Description	Within-participant average Ctrough of talazoparib at steady state for each participant was defined as the average (mean) value of the steady state Ctrough values (Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1 trough concentrations) for each individual participant.
Time Frame	Pre-dosing on Day 1 of Cycles 2, 3, 4

Outcome Measure Data

Analysis Population Description

The analysis population included all participants treated with talazoparib with drug plasma concentration results from at least 1 visit who had received 21 consecutive days of dosing without interruption prior to sample collection. Actual sample collection times were used to determine whether a pre-dose PK sample was dose-compliant.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	51
Geometric Mean (Geometric Coefficient of Variation) [pg/mL]	5001 (65.2)

28. Secondary Outcome

Title	Number of Participants Who Achieved Definitive Deterioration in Global Health Status (GHS)/Quality of Life (QoL) Per European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-30)
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes (PROs), consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent <10 point decrease.
Time Frame	Baseline to End of Treatment visit (assessed for maximum of 33 weeks)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	51
Count of Participants [Participants]	19 31.1%

29. Secondary Outcome

Title	Kaplan-Meier Estimate of Time to Definitive Deterioration in GHS/QoL Per EORTC QLQ-30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent <10 point decrease.
Time Frame	Baseline to End of Treatment visit (assessed for maximum of 33 weeks)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	51
Median (95% Confidence Interval) [Months]	NA

30. Secondary Outcome

Title	Probability of Not Achieving Definitive Deterioration in GHS/QoL Per EORTC QLQ-C30 at 3 and 6 Months
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all to 4=very much). For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent <10 point decrease. Probability of not achieving definitive deterioration (being event-free) at specified time points (3 and 6 months post-baseline) using the Kaplan Meier method were reported.
Time Frame	3 months and 6 months post-baseline

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	51
3 months	0.696
6 months	0.594

31. Secondary Outcome

Title	Number of Participants Who Achieved Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point increase from baseline without any subsequent <10 point increase.
Time Frame	Baseline to End of Treatment visit (assessed for maximum of 33 weeks)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	51
Count of Participants [Participants]	9 14.8%

32. Secondary Outcome

Title	Kaplan-Meier Estimate of Time to Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point increase from baseline without any subsequent <10 point increase.
Time Frame	Baseline to End of Treatment visit (assessed for maximum of 33 weeks)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	51
Median (95% Confidence Interval) [Months]	NA

33. Secondary Outcome

Title	Probability of Not Achieving Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 at 3 and 6 Months
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, with 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores (1=very poor to 7=excellent); other items have 4 possible scores (1=not at all to 4=very much). For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A linear transformation was applied to raw scores so that transformed scores lie between 0 to 100, with 0 being the best and 100 being the worst for this symptom scale. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as≥10 point increase from baseline without any subsequent <10 point increase. Probability of not achieving definitive deterioration (being event-free) at specified time points (3 and 6 months post-baseline) using Kaplan Meier method were reported.
Time Frame	3 months and 6 months post-baseline

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	51
3 months	0.863
6 months	0.818

34. Secondary Outcome

Title	Change From Baseline in Global QoL Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. Negative change from baseline indicates deterioration in GHS/QoL and positive change indicates improvement.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	50
Cycle 1 Day 15	-6.0
Cycle 2 Day 1	-7.4
Cycle 2 Day 15	-5.3
Cycle 3 Day 1	-9.1
Cycle 4 Day 1	-10.3
Cycle 5 Day 1	-13.0
Cycle 6 Day 1	-11.3
End of treatment	-7.9
Post-surgical follow-up	-13.3

35. Secondary Outcome

Title	Change From Baseline in Physical Functioning Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the physical functioning scale, participants self-rated levels of difficulty in doing strenuous activities, taking a walk, how much they needed to stay in bed or a chair, or needed help with eating, dressing, bathing, using the toilet. Negative change from baseline indicates deterioration in physical functioning and positive change indicates improvement.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	50
Cycle 1 Day 15	-3.6
Cycle 2 Day 1	-6.1
Cycle 2 Day 15	-6.1
Cycle 3 Day 1	-8.4
Cycle 4 Day 1	-9.3
Cycle 5 Day 1	-9.7
Cycle 6 Day 1	-9.0
End of treatment	-5.1
Post-surgical follow-up	-14.2

36. Secondary Outcome

Title	Change From Baseline in Role Functioning Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the role functioning scale, participants self-rated how much they were limited in doing work or daily activities, or in pursuing hobbies or other leisure time activities during the past week. Negative change from baseline values indicates deterioration in role functioning and positive change indicates improvement.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	50
Cycle 1 Day 15	-4.7
Cycle 2 Day 1	-9.4
Cycle 2 Day 15	-6.4
Cycle 3 Day 1	-10.9
Cycle 4 Day 1	-8.9
Cycle 5 Day 1	-9.4
Cycle 6 Day 1	-7.0
End of treatment	-4.8
Post-surgical follow-up	-21.7

37. Secondary Outcome

Title	Change From Baseline in Emotional Functioning Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the emotional functioning scale, participants self-rated how much they felt tense, worried, irritable or depressed during the past week. Negative change from baseline values indicates deterioration in emotional functioning and positive change indicates improvement.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	50
Cycle 1 Day 15	2.9
Cycle 2 Day 1	0.4
Cycle 2 Day 15	1.3
Cycle 3 Day 1	-0.9
Cycle 4 Day 1	-4.8
Cycle 5 Day 1	-3.0
Cycle 6 Day 1	-7.8
End of treatment	-4.0
Post-surgical follow-up	-3.1

38. Secondary Outcome

Title	Change From Baseline in Cognitive Functioning Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the cognitive functioning scale, participants self-rated the extent of difficulty in concentrating on things or remembering things during the past week. Negative change from baseline values indicates deterioration in cognitive functioning and positive change indicates improvement.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	50
Cycle 1 Day 15	-2.3
Cycle 2 Day 1	-5.4
Cycle 2 Day 15	-5.3
Cycle 3 Day 1	-6.9
Cycle 4 Day 1	-9.7
Cycle 5 Day 1	-7.7
Cycle 6 Day 1	-9.7
End of treatment	-7.1
Post-surgical follow-up	-7.8

39. Secondary Outcome

Title	Change From Baseline in Social Functioning Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the social functioning scale, participants self-rated how much their physical condition or medical treatment interfered with their family life and social activities during the past week. Negative change from baseline values indicates deterioration in social functioning and positive change indicates improvement.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	50
Cycle 1 Day 15	-2.3
Cycle 2 Day 1	-4.3
Cycle 2 Day 15	-1.9
Cycle 3 Day 1	-7.6
Cycle 4 Day 1	-5.4
Cycle 5 Day 1	-6.0
Cycle 6 Day 1	-8.1
End of treatment	-8.1
Post-surgical follow-up	-20.6

40. Secondary Outcome

Title	Change From Baseline in Fatigue Symptoms Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the fatigue symptoms scale, participants self-rated how much they had felt weak, tired or needed to rest during the past week. Negative change from baseline values indicates improvement of fatigue symptoms and positive change indicates deterioration.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	50
Cycle 1 Day 15	16.3
Cycle 2 Day 1	18.4
Cycle 2 Day 15	17.4
Cycle 3 Day 1	21.0
Cycle 4 Day 1	22.2
Cycle 5 Day 1	21.7
Cycle 6 Day 1	20.4
End of treatment	14.3
Post-surgical follow-up	23.3

41. Secondary Outcome

Title	Change From Baseline in Nausea and Vomiting Symptoms Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. Negative change from baseline values indicates improvement of nausea and vomiting symptoms and positive change indicates deterioration.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	50
Cycle 1 Day 15	11.2
Cycle 2 Day 1	8.0
Cycle 2 Day 15	7.2
Cycle 3 Day 1	5.4
Cycle 4 Day 1	3.9
Cycle 5 Day 1	4.3
Cycle 6 Day 1	7.5
End of treatment	0.5
Post-surgical follow-up	1.1

42. Secondary Outcome

Title	Change From Baseline in Pain Symptoms Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the pain symptoms scale, participants self-rated the extent of pain and how much the pain interfered with daily activities during the past week. Negative change from baseline values indicates improvement of pain symptoms and positive change indicates deterioration.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	50
Cycle 1 Day 15	-1.9
Cycle 2 Day 1	-0.0
Cycle 2 Day 15	-1.5
Cycle 3 Day 1	0.7
Cycle 4 Day 1	-2.7
Cycle 5 Day 1	1.3
Cycle 6 Day 1	-1.1
End of treatment	1.4
Post-surgical follow-up	14.4

43. Secondary Outcome

Title	Change From Baseline in Dyspnoea Symptoms Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the dyspnoea symptoms scale, participants self-rated the intensity of shortness of breath during the past week. Negative change from baseline values indicates improvement of dyspnoea symptoms and positive change indicates deterioration.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	50
Cycle 1 Day 15	-0.8
Cycle 2 Day 1	5.1
Cycle 2 Day 15	5.3
Cycle 3 Day 1	8.0
Cycle 4 Day 1	16.3
Cycle 5 Day 1	8.5
Cycle 6 Day 1	8.6
End of treatment	3.8
Post-surgical follow-up	4.4

44. Secondary Outcome

Title	Change From Baseline in Insomnia Symptoms Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the insomnia symptoms scale, participants self-rated the intensity of shortness of breath during the past week. Negative change from baseline values indicates improvement of insomnia symptoms and positive change indicates deterioration.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	50
Cycle 1 Day 15	-4.7
Cycle 2 Day 1	-4.3
Cycle 2 Day 15	-10.6
Cycle 3 Day 1	-6.5
Cycle 4 Day 1	-7.0
Cycle 5 Day 1	-2.6
Cycle 6 Day 1	-6.5
End of treatment	-4.8
Post-surgical follow-up	1.1

45. Secondary Outcome

Title	Change From Baseline in Appetite Loss Symptoms Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the appetite loss symptoms scale, participants self-rated the extent of lack of appetite during the past week. Negative change from baseline values indicates improvement of appetite loss symptoms and positive change indicates deterioration.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	50
Cycle 1 Day 15	10.1
Cycle 2 Day 1	3.6
Cycle 2 Day 15	0.8
Cycle 3 Day 1	5.8
Cycle 4 Day 1	3.1
Cycle 5 Day 1	4.3
Cycle 6 Day 1	4.3
End of treatment	1.9
Post-surgical follow-up	2.2

46. Secondary Outcome

Title	Change From Baseline in Constipation Symptoms Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the constipation symptoms scale, participants self-rated the intensity of constipation during the past week. Negative change from baseline values indicates improvement of constipation symptoms and positive change indicates deterioration.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	50
Cycle 1 Day 15	12.4
Cycle 2 Day 1	9.4
Cycle 2 Day 15	12.1
Cycle 3 Day 1	8.0
Cycle 4 Day 1	6.2
Cycle 5 Day 1	7.7
Cycle 6 Day 1	5.4
End of treatment	3.8
Post-surgical follow-up	3.3

47. Secondary Outcome

Title	Change From Baseline in Diarrhea Symptoms Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the diarrhea symptoms scale, participants self-rated the intensity of diarrhea during the past week. Negative change from baseline values indicates improvement of diarrhea symptoms and positive change indicates deterioration.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	50
Cycle 1 Day 15	1.6
Cycle 2 Day 1	2.2
Cycle 2 Day 15	1.5
Cycle 3 Day 1	0.0
Cycle 4 Day 1	2.3
Cycle 5 Day 1	3.4
Cycle 6 Day 1	0.0
End of treatment	1.9
Post--surgical follow-up	1.1

48. Secondary Outcome

Title	Change From Baseline in Financial Difficulties Per EORTC QLQ-C30
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the symptom scale of financial difficulties, participants self-rated how much their physical condition or medical treatment caused financial difficulties. Negative change from baseline values indicates improvement of financial difficulties and positive change indicates deterioration.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	50
Cycle 1 Day 15	-3.9
Cycle 2 Day 1	-1.4
Cycle 2 Day 15	-3.0
Cycle 3 Day 1	-0.7
Cycle 4 Day 1	1.6
Cycle 5 Day 1	5.1
Cycle 6 Day 1	3.2
End of treatment	10.5
Post-surgical follow-up	16.7

49. Secondary Outcome

Title	Change From Baseline in Body Image Per EORTC QLQ Breast Cancer Quality of Life Questionnaire (EORTC QLQ-BR23)
Description	EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of body image, participants self-rated how much they felt physically less attractive or less feminine, difficult to look at themselves naked, or dissatisfied with their body during the past week. Negative change from baseline indicates worsening of self-rated body image and positive change indicates improvement.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	49
Cycle 1 Day 15	0.2
Cycle 2 Day 1	1.7
Cycle 2 Day 15	-0.2
Cycle 3 Day 1	-0.4
Cycle 4 Day 1	-6.3
Cycle 5 Day 1	-9.4
Cycle 6 Day 1	-6.1
End of treatment	-6.9
Post-surgical follow-up	-13.8

50. Secondary Outcome

Title	Change From Baseline in Sexual Functioning Per EORTC QLQ-BR23
Description	EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the sexual functioning scale, participants self-rated to what extent they were interested in sex and were sexually active (with or without intercourse) during the past 4 weeks. Negative change from baseline values indicates worsening of sexual functioning and positive change indicates improvement.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	49
Cycle 1 Day 15	-1.6
Cycle 2 Day 1	-3.0
Cycle 2 Day 15	-2.7
Cycle 3 Day 1	-0.4
Cycle 4 Day 1	-1.2
Cycle 5 Day 1	-3.5
Cycle 6 Day 1	-2.8
End of treatment	-3.4
Post-surgical follow-up	-10.9

51. Secondary Outcome

Title	Change From Baseline in Sexual Enjoyment Per EORTC QLQ-BR23
Description	EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of sexual enjoyment, participants self-rated to what extent sex was enjoyable for them during the past 4 weeks. Negative change from baseline values indicates worsening of sexual enjoyment and positive change indicates improvement.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	26
Cycle 1 Day 15	-3.3
Cycle 2 Day 1	0.0
Cycle 2 Day 15	-3.7
Cycle 3 Day 1	-10.5
Cycle 4 Day 1	-12.3
Cycle 5 Day 1	-5.9
Cycle 6 Day 1	-12.8
End of treatment	-13.3
Post-surgical follow-up	-18.5

52. Secondary Outcome

Title	Change From Baseline in Future Perspective Per EORTC QLQ-BR23
Description	EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of future perspective, participants self-rated how much they were worried about their health in the future. Negative change from baseline values indicates worsening of future perspective and positive change indicates improvement.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	49
Cycle 1 Day 15	3.1
Cycle 2 Day 1	11.4
Cycle 2 Day 15	11.6
Cycle 3 Day 1	5.9
Cycle 4 Day 1	5.6
Cycle 5 Day 1	6.1
Cycle 6 Day 1	6.7
End of treatment	-2.0
Post-surgical follow-up	10.3

53. Secondary Outcome

Title	Change From Baseline in Systemic Therapy Side Effects Per EORTC QLQ-BR23
Description	EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the systemic therapy side effects scale, participants self-rated the intensity of symptoms of dry mouth, unusual taste, pain and irritation of eyes, hair loss, feeling ill or unwell, hot flushes and headaches during the past week. Negative change from baseline= improvement of these side effects, positive change = deterioration.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	49
Cycle 1 Day 15	7.1
Cycle 2 Day 1	6.6
Cycle 2 Day 15	9.1
Cycle 3 Day 1	11.2
Cycle 4 Day 1	15.0
Cycle 5 Day 1	13.5
Cycle 6 Day 1	16.5
End of treatment	6.9
Post-surgical follow-up	3.3

54. Secondary Outcome

Title	Change From Baseline in Breast Symptoms Per EORTC QLQ-BR23
Description	EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the breast symptoms scale, participants self-rated how much they had pain or skin problems (e.g. itchy, dry, flaky) on or in the area of affected breast, and how much this area was swollen or oversensitive during the past week. Negative change from baseline indicates improvement of breast symptoms and positive change indicates deterioration.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	49
Cycle 1 Day 15	-2.1
Cycle 2 Day 1	-4.9
Cycle 2 Day 15	-9.1
Cycle 3 Day 1	-8.0
Cycle 4 Day 1	-5.6
Cycle 5 Day 1	-7.7
Cycle 6 Day 1	-6.4
End of treatment	0.2
Post-surgical follow-up	8.6

55. Secondary Outcome

Title	Change From Baseline in Arm Symptoms Per EORTC QLQ-BR23
Description	EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the arm symptoms scale, participants self-rated how much they had pain in the arm or shoulder, how much the arm or hand was swollen, and difficulty in raising the arm or moving it sideways. Negative change from baseline indicates improvement of arm symptoms and positive change indicates deterioration.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	49
Cycle 1 Day 15	-1.6
Cycle 2 Day 1	-0.8
Cycle 2 Day 15	-1.6
Cycle 3 Day 1	-0.7
Cycle 4 Day 1	-1.3
Cycle 5 Day 1	0.3
Cycle 6 Day 1	-1.5
End of treatment	-1.0
Post-surgical follow-up	13.0

56. Secondary Outcome

Title	Change From Baseline in Upset by Hair Loss Per EORTC QLQ-BR23
Description	EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the upset by hair loss scale, participants self-rated how upset they were due to loss of hair during the past week. Negative change from baseline values indicates improvement of upset by hair loss and positive change indicates deterioration.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	3
Cycle 1 Day 15	0.0
Cycle 2 Day 1	-33.3
Cycle 2 Day 15	-11.1
Cycle 3 Day 1	33.33
Cycle 4 Day 1	11.1
End of treatment	33.33
Post-surgical follow-up	33.3

57. Secondary Outcome

Title	Number of Participants With Deterioration in Nausea/Vomiting Symptoms
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Deterioration in nausea and vomiting symptoms was defined as a 10 point or more increase from baseline for that specific time point.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who completed a baseline and at least one post-baseline QoL assessment prior to end of study treatment. Number of Participants Analyzed refers to participants who were evaluable for this outcome measure. Number analyzed refers to participants who were evaluable for this outcome measure at the specific visit.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	51
Cycle 1 Day 15	21 34.4%
Cycle 2 Day 1	20 32.8%
Cycle 2 Day 15	18 29.5%
Cycle 3 Day 1	14 23%
Cycle 4 Day 1	10 16.4%
Cycle 5 Day 1	11 18%
Cycle 6 Day 1	10 16.4%
End of treatment	3 4.9%
Post-surgical follow-up	5 8.2%

58. Secondary Outcome

Title	Number of Participants With Improvement in Nausea/Vomiting Symptoms
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Improvement in nausea and vomiting symptoms was defined as a 10 point or more decrease from baseline for that specific time point.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who completed a baseline and at least one post-baseline QoL assessment prior to end of study treatment. Number of Participants Analyzed refers to participants who were evaluable for this outcome measure. Number analyzed refers to participants who were evaluable for this outcome measure at the specific visit.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	51
Cycle 1 Day 15	1 1.6%
Cycle 2 Day 1	2 3.3%
Cycle 2 Day 15	2 3.3%
Cycle 3 Day 1	2 3.3%
Cycle 4 Day 1	2 3.3%
Cycle 5 Day 1	2 3.3%
Cycle 6 Day 1	0 0%
End of treatment	3 4.9%
Post-surgical follow-up	3 4.9%

59. Secondary Outcome

Title	Number of Participants With No Change in Nausea/Vomiting Symptoms
Description	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all to 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. No change in nausea/vomiting symptoms=having neither deterioration (≥10 point increase from baseline) nor improvement (≥10 point decrease from baseline) for the time point.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who completed a baseline and at least one post-baseline QoL assessment prior to end of study treatment. Number of Participants Analyzed refers to participants who were evaluable for this outcome measure. Number analyzed refers to participants who were evaluable for this outcome measure at the specific visit.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	51
Cycle 1 Day 15	21 34.4%
Cycle 2 Day 1	24 39.3%
Cycle 2 Day 15	24 39.3%
Cycle 3 Day 1	30 49.2%
Cycle 4 Day 1	31 50.8%
Cycle 5 Day 1	26 42.6%
Cycle 6 Day 1	21 34.4%
End of treatment	29 47.5%
Post-surgical follow-up	22 36.1%

60. Secondary Outcome

Title	Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Description	Missed expected menstrual period was assessed electronically using the PRO CTCAE questionnaire, a PRO measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials. This objective captures the concept of fertility preservation through PRO, since there is a possible fertility sparing effect of talazoparib versus chemotherapy.
Time Frame	Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment. Post-menopausal participants were excluded from this evaluation. Number of participants analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.

Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Measure Participants	32
Baseline	0 0%
Cycle 1 Day 15	1 1.6%
Cycle 2 Day 1	0 0%
Cycle 2 Day 15	2 3.3%
Cycle 3 Day 1	0 0%
Cycle 4 Day 1	3 4.9%
Cycle 5 Day 1	1 1.6%
Cycle 6 Day 1	1 1.6%
End of treatment	0 0%
Post-surgical follow-up	1 1.6%

Adverse Events

Time Frame	Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months).
Adverse Event Reporting Description	The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Arm/Group Title	Talazoparib 1 mg QD
Arm/Group Description	During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
All Cause Mortality
	Talazoparib 1 mg QD
	Affected / at Risk (%)	# Events
Total	2/61 (3.3%)
Serious Adverse Events
	Talazoparib 1 mg QD
	Affected / at Risk (%)	# Events
Total	11/61 (18%)
Blood and lymphatic system disorders
Anaemia	9/61 (14.8%)
Neutropenia	1/61 (1.6%)
Gastrointestinal disorders
Intestinal obstruction	1/61 (1.6%)
General disorders
Influenza like illness	1/61 (1.6%)
Other (Not Including Serious) Adverse Events
	Talazoparib 1 mg QD
	Affected / at Risk (%)	# Events
Total	60/61 (98.4%)
Blood and lymphatic system disorders
Anaemia	30/61 (49.2%)
Gastrointestinal disorders
Abdominal pain	4/61 (6.6%)
Constipation	19/61 (31.1%)
Diarrhoea	13/61 (21.3%)
Dry mouth	4/61 (6.6%)
Gastrooesophageal reflux disease	4/61 (6.6%)
Nausea	42/61 (68.9%)
Stomatitis	6/61 (9.8%)
Vomiting	7/61 (11.5%)
General disorders
Fatigue	48/61 (78.7%)
Infections and infestations
Upper respiratory tract infection	12/61 (19.7%)
Urinary tract infection	4/61 (6.6%)
Investigations
Alanine aminotransferase increased	7/61 (11.5%)
Neutrophil count decreased	9/61 (14.8%)
White blood cell count decreased	9/61 (14.8%)
Metabolism and nutrition disorders
Decreased appetite	8/61 (13.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	11/61 (18%)
Back pain	5/61 (8.2%)
Myalgia	9/61 (14.8%)
Pain in extremity	6/61 (9.8%)
Nervous system disorders
Dizziness	20/61 (32.8%)
Dysgeusia	5/61 (8.2%)
Headache	26/61 (42.6%)
Psychiatric disorders
Anxiety	11/61 (18%)
Insomnia	11/61 (18%)
Reproductive system and breast disorders
Breast pain	7/61 (11.5%)
Menstruation irregular	4/61 (6.6%)
Respiratory, thoracic and mediastinal disorders
Cough	9/61 (14.8%)
Dyspnoea	10/61 (16.4%)
Nasal congestion	6/61 (9.8%)
Oropharyngeal pain	7/61 (11.5%)
Skin and subcutaneous tissue disorders
Alopecia	35/61 (57.4%)
Pruritus	5/61 (8.2%)
Rash	7/61 (11.5%)
Vascular disorders
Hot flush	7/61 (11.5%)
Hypertension	6/61 (9.8%)

Limitations/Caveats

The study was prematurely terminated by the sponsor due to a change in clinical development strategy not related to safety or efficacy after all participants completed safety follow-up.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.