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OlympiA: Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02032823
Collaborator
Breast International Group (Other), Frontier Science & Technology Research Foundation, Inc. (Industry), NRG Oncology (Other), Myriad Genetic Laboratories, Inc. (Industry), Br.E.A.S.T. -Data Center & Operational Office Institut Jules Bordet (Other), Merck Sharp & Dohme LLC (Industry)
1,836
Enrollment
699
Locations
2
Arms
181.2
Anticipated Duration (Months)
2.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Patients will be randomised in 1:1 ratio to either olaparib or placebo. Randomisation will be stratified by Hormone receptor status (ER and/or PgR positive/HER2 negative versus TNBC), prior neoadjuvant versus adjuvant chemotherapy and prior platinum use for breast cancer.

Randomised patients will receive study treatment for up to a maximum of 12 months. All patients will have safety assessments every 2 weeks during the first month, every 4 weeks for the following 5 months and 3 monthly for the remaining 6 months of study treatment plus 30 days after its discontinuation. Following randomisation, all patients will be assessed regularly for signs, symptoms and evidence of disease recurrence by taking medical history, physical examination and mammogram/breast MRI. Efficacy assessments will be performed on a 3 monthly basis during the first 2 years, followed by 6 monthly assessments for years 3, 4 and 5 and annually thereafter. All patients (except those with bilateral mastectomy) will have mammogram / breast MRI annually for 10 years beginning 6 months after randomisation.

All randomised patients will have clinical assessment visits for 10 years following their randomisation into the study. Once a patient completes 10 years of clinical assessment they will enter the survival follow up phase of the trial which will continue until 10 years after the last patient is randomised.

Study Design

Study Type:
Interventional
Actual Enrollment :
1836 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With gBRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
Actual Study Start Date :
Apr 22, 2014
Actual Primary Completion Date :
Mar 27, 2020
Anticipated Study Completion Date :
May 28, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Olaparib

Olaparib tablets 300mg b.i.d. p.o.

Drug: Olaparib
Patients will be administred olaparib orally twice daily (b.i.d.) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 ml of water.
Other Names:
  • Lynparza

    		•
    Placebo Comparator: Placebo

    Placebo tablets b.i.d. p.o.

    Drug: Placebo
    Patients will be administred matching placebo. Two (2) tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 ml of water.

    Outcome Measures

    Primary Outcome Measures

    1. Invasive Disease Free Survival (IDFS) [From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)]

      An IDFS event is defined as the first occurrence of loco-regional or distant recurrence or new cancer or death from any cause.

    Secondary Outcome Measures

    1. Distant Disease Free Survival (DDFS) [From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)]

      A DDFS event is defined as documented evidence of first distant recurrence of breast cancer or death from any cause

    2. Overall Survival (OS) [From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)]

      An OS event is defined as death by any cause.

    3. Number of Participants With Contralateral Breast Cancers, New Primary Ovarian Cancer, New Primary Fallopian Tube Cancer and New Primary Peritoneal Cancer [From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)]

      Number of patients with contralateral invasive breast cancer, contralateral non-invasive breast cancer, new primary ovarian cancer, new primary fallopian tube cancer and new primary peritoneal cancer. Analysis of contralateral breast cancers exclude patients with a bilateral mastectomy prior to randomisation. Analysis of new primary ovarian cancers excludes male patients and patients with a bilateral oophorectomy prior to randomisation. Analysis of new primary fallopian tube cancer excludes male patients and patients with a bilateral salpingectomy prior to randomisation. Analysis of new primary peritoneal cancers excludes male patients.

    4. Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy [6 and 12 months after randomisation]

      Change from baseline for FACIT-Fatigue Score at 6 and 12 months for patients who completed neoadjuvant chemotherapy. Adjusted least-square mean changes and 95% Confidence Interval (CI) are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. FACIT-Fatigue score ranges from 0 to 52 with higher score indicating less fatigue.

    5. Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Adjuvant Chemotherapy [6 and 12 months after randomisation]

      Change from baseline for FACIT-Fatigue Score at 6 and 12 months for patients who completed adjuvant chemotherapy. Adjusted least-square mean changes and 95% CI are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. FACIT-Fatigue score ranges from 0 to 52 with higher score indicating less fatigue.

    6. Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Neoadjuvant Chemotherapy [6 and 12 months after randomisation]

      Change from baseline for EORTC QLQ-C30 Global health status QOL (Quality of Life) Score at 6 and 12 months for patients who completed neoadjuvant chemotherapy. Adjusted least-square mean changes and 95% CI are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. EORTC QLQ-C30 scores range from 0 to 100 with higher score indicating better quality of life.

    7. Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Adjuvant Chemotherapy [6 and 12 months after randomisation]

      Change from baseline for EORTC QLQ-C30 Global health status QOL (Quality of Life) Score at 6 and 12 months for patients who completed adjuvant chemotherapy. Adjusted least-square mean changes and 95% CI are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. EORTC QLQ-C30 scores range from 0 to 100 with higher score indicating better quality of life.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast that is one of the following phenotypes:

    1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative (not eligible for anti-HER2 therapy)

    2. ER and/or PgR positive, HER2 negative

    • Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).

    • Completed adequate breast and axilla surgery.

    • Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both. Prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed.

    • ECOG 0-1.

    Exclusion criteria:

    • Any previous treatment with a PARP inhibitor, including olaparib and/or known hypersensitivity to any of the excipients of study treatment.

    • Patients with second primary malignancy. EXCEPTIONS are:

    1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma

    2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5 years prior to randomisation and treated with no evidence of disease recurrence and for whom no more than one line of chemotherapy was applied.

    • Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks. Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.

    • Evidence of metastatic breast cancer

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    Sponsors and Collaborators

    • AstraZeneca
    • Breast International Group
    • Frontier Science & Technology Research Foundation, Inc.
    • NRG Oncology
    • Myriad Genetic Laboratories, Inc.
    • Br.E.A.S.T. -Data Center & Operational Office Institut Jules Bordet
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: Andrew Tutt, Doctor of Medicine, Integrated Cancer Centre Guy's Hospital, King's College, London School of Medicine, London, UK
    • Principal Investigator: Judy Garber, Doctor of Medicine, Harvard Medical School, Center for Cancer Genetics and Prevention, Dana-Farber Cancer Institute, Susan F. Smither Center for Women's Cancers, 450 Brookline Avenue, Boston; MA 02215, US
    • Principal Investigator: Charles Geyer, Doctor of Medicine, Virginia Commonwealth University Massey Cancer Center, McGlothlin Medical Education Center, Room 12-217, 1201 East Marshall St., PO Box 980070, Richmond, VA 23298-0070, USA

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT02032823
    Other Study ID Numbers:
    • D081CC00006
    • NSABP B-55
    • BIG 6-13
    First Posted:
    Jan 10, 2014
    Last Update Posted:
    Jun 13, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by AstraZeneca
    Breast Cancer
    Adjuvant
    Olaparib
    BRCA 1/2
    HER2
    Additional relevant MeSH terms:
    Breast Neoplasms
    Olaparib

    Study Results

    Participant Flow

    Recruitment Details The first patient was enrolled on 22 April 2014. Patients were randomised from 546 centres in 23 countries worldwide.
    Pre-assignment Detail Patients with unknown germline BRCA (gBRCA) mutation status prior to randomisation underwent Screening Part 1 to ascertain gBRCA mutation status during, or prior to, neoadjuvant/adjuvant chemotherapy. All patients with known gBRCA mutation status (including those found through Screening Part 1) underwent Screening Part 2.
    Arm/Group Title Olaparib Placebo
    Arm/Group Description Olaparib tablets 300mg taken orally twice daily. Placebo tablets taken orally twice daily.
    Period Title: Overall Study
    STARTED 921 915
    COMPLETED 0 0
    NOT COMPLETED 921 915

    Baseline Characteristics

    Arm/Group Title Olaparib Placebo Total
    Arm/Group Description Olaparib tablets 300mg taken orally twice daily. Placebo tablets taken orally twice daily. Total of all reporting groups
    Overall Participants 921 915 1836
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    43.0
    (9.8)
    43.6
    (10.1)
    43.3
    (10.0)
    Age, Customized (Number) [Number]
    <30 years
    51
    5.5%
    59
    6.4%
    110
    6%
    30-39 years
    333
    36.2%
    306
    33.4%
    639
    34.8%
    40-49 years
    315
    34.2%
    308
    33.7%
    623
    33.9%
    50-59 years
    166
    18%
    172
    18.8%
    338
    18.4%
    60-69 years
    48
    5.2%
    66
    7.2%
    114
    6.2%
    >=70 years
    8
    0.9%
    4
    0.4%
    12
    0.7%
    Sex: Female, Male (Count of Participants)
    Female
    919
    99.8%
    911
    99.6%
    1830
    99.7%
    Male
    2
    0.2%
    4
    0.4%
    6
    0.3%
    Race/Ethnicity, Customized (Number) [Number]
    HISPANIC OR LATINO
    34
    3.7%
    24
    2.6%
    58
    3.2%
    NOT HISPANIC OR LATINO
    805
    87.4%
    812
    88.7%
    1617
    88.1%
    NOT KNOWN, NOT RECORDED, OR REFUSED
    82
    8.9%
    79
    8.6%
    161
    8.8%
    Race/Ethnicity, Customized (Number) [Number]
    AMERICAN INDIAN OR ALASKA NATIVE
    3
    0.3%
    1
    0.1%
    4
    0.2%
    ASIAN
    259
    28.1%
    272
    29.7%
    531
    28.9%
    BLACK OR AFRICAN AMERICAN
    19
    2.1%
    29
    3.2%
    48
    2.6%
    NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
    1
    0.1%
    0
    0%
    1
    0.1%
    WHITE
    626
    68%
    599
    65.5%
    1225
    66.7%
    OTHER
    3
    0.3%
    6
    0.7%
    9
    0.5%
    MISSING
    10
    1.1%
    8
    0.9%
    18
    1%
    Region of Enrollment (Number) [Number]
    Argentina
    16
    1.7%
    12
    1.3%
    28
    1.5%
    Australia
    30
    3.3%
    30
    3.3%
    60
    3.3%
    Austria
    28
    3%
    25
    2.7%
    53
    2.9%
    Belgium
    12
    1.3%
    26
    2.8%
    38
    2.1%
    Canada
    11
    1.2%
    23
    2.5%
    34
    1.9%
    China
    117
    12.7%
    130
    14.2%
    247
    13.5%
    France
    77
    8.4%
    65
    7.1%
    142
    7.7%
    Germany
    106
    11.5%
    92
    10.1%
    198
    10.8%
    United Kingdom
    60
    6.5%
    46
    5%
    106
    5.8%
    Hungary
    8
    0.9%
    9
    1%
    17
    0.9%
    Iceland
    5
    0.5%
    1
    0.1%
    6
    0.3%
    Israel
    30
    3.3%
    35
    3.8%
    65
    3.5%
    Italy
    30
    3.3%
    27
    3%
    57
    3.1%
    Japan
    64
    6.9%
    76
    8.3%
    140
    7.6%
    Netherlands
    11
    1.2%
    18
    2%
    29
    1.6%
    Poland
    50
    5.4%
    59
    6.4%
    109
    5.9%
    Portugal
    7
    0.8%
    6
    0.7%
    13
    0.7%
    Korea, Republic Of
    53
    5.8%
    44
    4.8%
    97
    5.3%
    Spain
    63
    6.8%
    46
    5%
    109
    5.9%
    Sweden
    20
    2.2%
    15
    1.6%
    35
    1.9%
    Switzerland
    4
    0.4%
    17
    1.9%
    21
    1.1%
    Taiwan, Province Of China
    8
    0.9%
    4
    0.4%
    12
    0.7%
    United States
    111
    12.1%
    109
    11.9%
    220
    12%

    Outcome Measures

    1. Primary Outcome
    Title Invasive Disease Free Survival (IDFS)
    Description An IDFS event is defined as the first occurrence of loco-regional or distant recurrence or new cancer or death from any cause.
    Time Frame From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS)
    Arm/Group Title Olaparib Placebo
    Arm/Group Description Olaparib tablets 300mg taken orally twice daily. Placebo tablets taken orally twice daily.
    Measure Participants 921 915
    Count of Participants [Participants]
    106
    11.5%
    178
    19.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Olaparib, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0000073
    Comments A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.
    Method Log Rank
    Comments Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.581
    Confidence Interval (2-Sided) 99.5%
    0.409 to 0.816
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, <1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.
    2. Secondary Outcome
    Title Distant Disease Free Survival (DDFS)
    Description A DDFS event is defined as documented evidence of first distant recurrence of breast cancer or death from any cause
    Time Frame From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS)
    Arm/Group Title Olaparib Placebo
    Arm/Group Description Olaparib tablets 300mg taken orally twice daily. Placebo tablets taken orally twice daily.
    Measure Participants 921 915
    Count of Participants [Participants]
    89
    9.7%
    152
    16.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Olaparib, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0000257
    Comments A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.
    Method Log Rank
    Comments Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.574
    Confidence Interval (2-Sided) 99.5%
    0.392 to 0.831
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, <1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.
    3. Secondary Outcome
    Title Overall Survival (OS)
    Description An OS event is defined as death by any cause.
    Time Frame From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS)
    Arm/Group Title Olaparib Placebo
    Arm/Group Description Olaparib tablets 300mg taken orally twice daily. Placebo tablets taken orally twice daily.
    Measure Participants 921 915
    Count of Participants [Participants]
    59
    6.4%
    86
    9.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Olaparib, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0236
    Comments A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.
    Method Log Rank
    Comments Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.683
    Confidence Interval (2-Sided) 99%
    0.438 to 1.053
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, <1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.
    4. Secondary Outcome
    Title Number of Participants With Contralateral Breast Cancers, New Primary Ovarian Cancer, New Primary Fallopian Tube Cancer and New Primary Peritoneal Cancer
    Description Number of patients with contralateral invasive breast cancer, contralateral non-invasive breast cancer, new primary ovarian cancer, new primary fallopian tube cancer and new primary peritoneal cancer. Analysis of contralateral breast cancers exclude patients with a bilateral mastectomy prior to randomisation. Analysis of new primary ovarian cancers excludes male patients and patients with a bilateral oophorectomy prior to randomisation. Analysis of new primary fallopian tube cancer excludes male patients and patients with a bilateral salpingectomy prior to randomisation. Analysis of new primary peritoneal cancers excludes male patients.
    Time Frame From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS)
    Arm/Group Title Olaparib Placebo
    Arm/Group Description Olaparib tablets 300mg taken orally twice daily. Placebo tablets taken orally twice daily.
    Measure Participants 921 915
    Contralateral invasive breast cancer
    11
    1.2%
    14
    1.5%
    Contralateral non-invasive breast cancer
    2
    0.2%
    3
    0.3%
    New primary ovarian cancer
    1
    0.1%
    4
    0.4%
    New primary fallopian tube cancer
    1
    0.1%
    4
    0.4%
    New primary peritoneal cancer
    0
    0%
    0
    0%
    5. Secondary Outcome
    Title Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy
    Description Change from baseline for FACIT-Fatigue Score at 6 and 12 months for patients who completed neoadjuvant chemotherapy. Adjusted least-square mean changes and 95% Confidence Interval (CI) are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. FACIT-Fatigue score ranges from 0 to 52 with higher score indicating less fatigue.
    Time Frame 6 and 12 months after randomisation

    Outcome Measure Data

    Analysis Population Description
    Patient reported outcomes (PRO) Analysis Set
    Arm/Group Title Olaparib Placebo
    Arm/Group Description Olaparib tablets 300mg taken orally twice daily. Placebo tablets taken orally twice daily.
    Measure Participants 371 356
    Change from baseline FACIT-Fatigue Score to 6 months
    -1.5
    -0.2
    Change from baseline FACIT-Fatigue Score to 12 months
    -1.5
    0.0
    6. Secondary Outcome
    Title Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Adjuvant Chemotherapy
    Description Change from baseline for FACIT-Fatigue Score at 6 and 12 months for patients who completed adjuvant chemotherapy. Adjusted least-square mean changes and 95% CI are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. FACIT-Fatigue score ranges from 0 to 52 with higher score indicating less fatigue.
    Time Frame 6 and 12 months after randomisation

    Outcome Measure Data

    Analysis Population Description
    Patient reported outcomes (PRO) Analysis Set
    Arm/Group Title Olaparib Placebo
    Arm/Group Description Olaparib tablets 300mg taken orally twice daily. Placebo tablets taken orally twice daily.
    Measure Participants 375 403
    Change from baseline FACIT-Fatigue Score to 6 months
    -0.7
    0.6
    Change from baseline FACIT-Fatigue Score to 12 months
    -0.8
    0.5
    7. Secondary Outcome
    Title Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Neoadjuvant Chemotherapy
    Description Change from baseline for EORTC QLQ-C30 Global health status QOL (Quality of Life) Score at 6 and 12 months for patients who completed neoadjuvant chemotherapy. Adjusted least-square mean changes and 95% CI are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. EORTC QLQ-C30 scores range from 0 to 100 with higher score indicating better quality of life.
    Time Frame 6 and 12 months after randomisation

    Outcome Measure Data

    Analysis Population Description
    Patient reported outcomes (PRO) Analysis Set
    Arm/Group Title Olaparib Placebo
    Arm/Group Description Olaparib tablets 300mg taken orally twice daily. Placebo tablets taken orally twice daily.
    Measure Participants 380 358
    Change from baseline EORTC QLQ-C30 Global health status score to 6 months
    -0.2
    0.5
    Change from baseline EORTC QLQ-C30 Global health status score to 12 months
    0.4
    2.8
    8. Secondary Outcome
    Title Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Adjuvant Chemotherapy
    Description Change from baseline for EORTC QLQ-C30 Global health status QOL (Quality of Life) Score at 6 and 12 months for patients who completed adjuvant chemotherapy. Adjusted least-square mean changes and 95% CI are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. EORTC QLQ-C30 scores range from 0 to 100 with higher score indicating better quality of life.
    Time Frame 6 and 12 months after randomisation

    Outcome Measure Data

    Analysis Population Description
    Patient reported outcomes (PRO) Analysis Set
    Arm/Group Title Olaparib Placebo
    Arm/Group Description Olaparib tablets 300mg taken orally twice daily. Placebo tablets taken orally twice daily.
    Measure Participants 383 406
    Change from baseline EORTC QLQ-C30 Global health status score to 6 months
    -0.4
    2.3
    Change from baseline EORTC QLQ-C30 Global health status score to 12 months
    0.7
    3.3

    Adverse Events

    Time Frame Maximum of approximately 13 months
    Adverse Event Reporting Description All-Cause Mortality was collected for the Full Analysis Set (FAS). Serious and Other Adverse Events were collected for the Safety Analysis Set (SAS), which includes all participants who received at least 1 dose of randomized study treatment (N=1815). There were 10 patients in the olaparib arm and 11 patients in the placebo arm that did not receive study treatment and therefore are excluded from the SAS. The Other Adverse Events section reports AE's of any grade where the frequency is above 5%.
    Arm/Group Title Olaparib Placebo
    Arm/Group Description Olaparib tablets 300mg taken orally twice daily. Placebo tablets taken orally twice daily.
    All Cause Mortality
    Olaparib Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 59/921 (6.4%) 86/915 (9.4%)
    Serious Adverse Events
    Olaparib Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 79/911 (8.7%) 76/904 (8.4%)
    Blood and lymphatic system disorders
    Anaemia 15/911 (1.6%) 17 1/904 (0.1%) 1
    Febrile neutropenia 3/911 (0.3%) 3 0/904 (0%) 0
    Cardiac disorders
    Acute myocardial infarction 0/911 (0%) 0 1/904 (0.1%) 1
    Angina pectoris 1/911 (0.1%) 1 0/904 (0%) 0
    Cardiac arrest 1/911 (0.1%) 1 0/904 (0%) 0
    Cardiac failure 1/911 (0.1%) 1 0/904 (0%) 0
    Cardiac failure congestive 1/911 (0.1%) 1 0/904 (0%) 0
    Coronary artery disease 1/911 (0.1%) 1 0/904 (0%) 0
    Coronary artery dissection 0/911 (0%) 0 1/904 (0.1%) 1
    Myocardial infarction 0/911 (0%) 0 1/904 (0.1%) 1
    Pericardial effusion 1/911 (0.1%) 1 0/904 (0%) 0
    Ear and labyrinth disorders
    Deafness 0/911 (0%) 0 1/904 (0.1%) 1
    Sudden hearing loss 1/911 (0.1%) 1 0/904 (0%) 0
    Endocrine disorders
    Hypothyroidism 1/911 (0.1%) 1 0/904 (0%) 0
    Eye disorders
    Vision blurred 1/911 (0.1%) 1 0/904 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 0/911 (0%) 0 3/904 (0.3%) 3
    Chronic gastritis 1/911 (0.1%) 1 0/904 (0%) 0
    Colitis 1/911 (0.1%) 1 0/904 (0%) 0
    Diarrhoea 1/911 (0.1%) 1 0/904 (0%) 0
    Intestinal prolapse 0/911 (0%) 0 1/904 (0.1%) 1
    Large intestine polyp 0/911 (0%) 0 1/904 (0.1%) 1
    Melaena 0/911 (0%) 0 1/904 (0.1%) 1
    Nausea 1/911 (0.1%) 1 0/904 (0%) 0
    Small intestinal obstruction 1/911 (0.1%) 1 0/904 (0%) 0
    Vomiting 2/911 (0.2%) 2 0/904 (0%) 0
    General disorders
    Chest pain 1/911 (0.1%) 1 0/904 (0%) 0
    Fatigue 1/911 (0.1%) 5 0/904 (0%) 0
    Foreign body reaction 0/911 (0%) 0 1/904 (0.1%) 1
    Impaired healing 1/911 (0.1%) 1 0/904 (0%) 0
    Non-cardiac chest pain 1/911 (0.1%) 1 0/904 (0%) 0
    Pyrexia 1/911 (0.1%) 1 3/904 (0.3%) 3
    Hepatobiliary disorders
    Cholecystitis 0/911 (0%) 0 1/904 (0.1%) 1
    Cholecystitis acute 0/911 (0%) 0 1/904 (0.1%) 1
    Hepatic function abnormal 1/911 (0.1%) 1 0/904 (0%) 0
    Immune system disorders
    Anaphylactic reaction 1/911 (0.1%) 1 0/904 (0%) 0
    Infections and infestations
    Appendicitis 1/911 (0.1%) 1 0/904 (0%) 0
    Breast cellulitis 0/911 (0%) 0 1/904 (0.1%) 1
    Bronchitis 1/911 (0.1%) 1 0/904 (0%) 0
    Cellulitis 1/911 (0.1%) 1 2/904 (0.2%) 3
    Cystitis 0/911 (0%) 0 1/904 (0.1%) 1
    Device related infection 3/911 (0.3%) 3 2/904 (0.2%) 2
    Gastroenteritis 2/911 (0.2%) 2 0/904 (0%) 0
    Gingivitis 1/911 (0.1%) 1 0/904 (0%) 0
    Influenza 0/911 (0%) 0 1/904 (0.1%) 1
    Lower respiratory tract infection 0/911 (0%) 0 1/904 (0.1%) 1
    Lymphangitis 0/911 (0%) 0 1/904 (0.1%) 1
    Mastitis 3/911 (0.3%) 3 6/904 (0.7%) 6
    Pneumonia 1/911 (0.1%) 1 1/904 (0.1%) 1
    Urinary tract infection 1/911 (0.1%) 1 0/904 (0%) 0
    Wound infection 2/911 (0.2%) 2 1/904 (0.1%) 1
    Injury, poisoning and procedural complications
    Craniocerebral injury 0/911 (0%) 0 1/904 (0.1%) 1
    Gastrointestinal procedural complication 0/911 (0%) 0 1/904 (0.1%) 1
    Post procedural haematoma 1/911 (0.1%) 1 0/904 (0%) 0
    Post procedural haemorrhage 0/911 (0%) 0 1/904 (0.1%) 1
    Radiation pneumonitis 1/911 (0.1%) 1 0/904 (0%) 0
    Ureteric injury 1/911 (0.1%) 1 0/904 (0%) 0
    Vascular access complication 0/911 (0%) 0 1/904 (0.1%) 1
    Wound complication 0/911 (0%) 0 1/904 (0.1%) 1
    Wound dehiscence 1/911 (0.1%) 1 4/904 (0.4%) 4
    Investigations
    Blood bilirubin increased 0/911 (0%) 0 1/904 (0.1%) 3
    Neutrophil count decreased 1/911 (0.1%) 1 0/904 (0%) 0
    Platelet count decreased 0/911 (0%) 0 1/904 (0.1%) 1
    Metabolism and nutrition disorders
    Dehydration 1/911 (0.1%) 1 0/904 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 2/911 (0.2%) 2 1/904 (0.1%) 1
    Bone pain 0/911 (0%) 0 1/904 (0.1%) 1
    Chest wall mass 0/911 (0%) 0 1/904 (0.1%) 1
    Intervertebral disc protrusion 0/911 (0%) 0 1/904 (0.1%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia 1/911 (0.1%) 1 1/904 (0.1%) 1
    Benign breast neoplasm 0/911 (0%) 0 1/904 (0.1%) 1
    Breast cancer 1/911 (0.1%) 1 3/904 (0.3%) 3
    Breast cancer female 0/911 (0%) 0 2/904 (0.2%) 2
    Chest wall tumour 0/911 (0%) 0 1/904 (0.1%) 1
    Endometrial adenocarcinoma 1/911 (0.1%) 1 0/904 (0%) 0
    Fallopian tube cancer 0/911 (0%) 0 1/904 (0.1%) 1
    Fibroadenoma of breast 0/911 (0%) 0 1/904 (0.1%) 1
    Invasive lobular breast carcinoma 1/911 (0.1%) 1 0/904 (0%) 0
    Malignant melanoma 1/911 (0.1%) 1 4/904 (0.4%) 4
    Ovarian cancer 0/911 (0%) 0 4/904 (0.4%) 4
    Ovarian germ cell teratoma 0/911 (0%) 0 1/904 (0.1%) 1
    Nervous system disorders
    Ataxia 1/911 (0.1%) 1 0/904 (0%) 0
    Cognitive disorder 1/911 (0.1%) 1 0/904 (0%) 0
    Dizziness 0/911 (0%) 0 1/904 (0.1%) 1
    Headache 2/911 (0.2%) 2 1/904 (0.1%) 1
    Lacunar infarction 0/911 (0%) 0 1/904 (0.1%) 1
    Migraine with aura 0/911 (0%) 0 1/904 (0.1%) 1
    Sciatica 0/911 (0%) 0 1/904 (0.1%) 1
    Syncope 1/911 (0.1%) 1 1/904 (0.1%) 1
    Vith nerve disorder 1/911 (0.1%) 1 0/904 (0%) 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 0/911 (0%) 0 1/904 (0.1%) 1
    Product Issues
    Device dislocation 1/911 (0.1%) 1 0/904 (0%) 0
    Psychiatric disorders
    Bipolar disorder 1/911 (0.1%) 1 0/904 (0%) 0
    Depression 0/911 (0%) 0 2/904 (0.2%) 2
    Suicidal ideation 0/911 (0%) 0 1/904 (0.1%) 1
    Suicide attempt 1/911 (0.1%) 1 0/904 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 1/911 (0.1%) 1 0/904 (0%) 0
    Bladder disorder 0/911 (0%) 0 1/904 (0.1%) 1
    Nephrolithiasis 1/911 (0.1%) 1 0/904 (0%) 0
    Reproductive system and breast disorders
    Breast disorder 1/911 (0.1%) 1 0/904 (0%) 0
    Breast fibrosis 0/911 (0%) 0 1/904 (0.1%) 1
    Breast mass 0/911 (0%) 0 1/904 (0.1%) 1
    Breast pain 0/911 (0%) 0 1/904 (0.1%) 1
    Dysfunctional uterine bleeding 1/911 (0.1%) 1 0/904 (0%) 0
    Endometrial hyperplasia 1/911 (0.1%) 1 0/904 (0%) 0
    Metrorrhagia 1/911 (0.1%) 1 0/904 (0%) 0
    Ovarian cyst 1/911 (0.1%) 1 0/904 (0%) 0
    Ovarian haemorrhage 1/911 (0.1%) 1 0/904 (0%) 0
    Uterine polyp 1/911 (0.1%) 1 1/904 (0.1%) 1
    Vaginal haemorrhage 1/911 (0.1%) 1 0/904 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 0/911 (0%) 0 1/904 (0.1%) 1
    Dyspnoea 2/911 (0.2%) 2 0/904 (0%) 0
    Lung disorder 1/911 (0.1%) 1 0/904 (0%) 0
    Pneumonitis 2/911 (0.2%) 2 1/904 (0.1%) 1
    Pneumothorax 0/911 (0%) 0 1/904 (0.1%) 1
    Surgical and medical procedures
    Oophorectomy 0/911 (0%) 0 1/904 (0.1%) 1
    Vascular disorders
    Embolism 2/911 (0.2%) 2 0/904 (0%) 0
    Lymphoedema 1/911 (0.1%) 1 0/904 (0%) 0
    Other (Not Including Serious) Adverse Events
    Olaparib Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 791/911 (86.8%) 668/904 (73.9%)
    Blood and lymphatic system disorders
    Anaemia 200/911 (22%) 261 34/904 (3.8%) 39
    Gastrointestinal disorders
    Abdominal pain 86/911 (9.4%) 96 65/904 (7.2%) 77
    Constipation 84/911 (9.2%) 89 77/904 (8.5%) 87
    Diarrhoea 160/911 (17.6%) 198 124/904 (13.7%) 162
    Dyspepsia 55/911 (6%) 62 37/904 (4.1%) 39
    Nausea 518/911 (56.9%) 680 211/904 (23.3%) 265
    Stomatitis 81/911 (8.9%) 116 36/904 (4%) 38
    Vomiting 204/911 (22.4%) 293 74/904 (8.2%) 84
    General disorders
    Fatigue 365/911 (40.1%) 439 247/904 (27.3%) 287
    Influenza like illness 57/911 (6.3%) 64 43/904 (4.8%) 55
    Pain 68/911 (7.5%) 78 74/904 (8.2%) 83
    Pyrexia 48/911 (5.3%) 57 39/904 (4.3%) 44
    Infections and infestations
    Nasopharyngitis 31/911 (3.4%) 45 52/904 (5.8%) 74
    Upper respiratory tract infection 79/911 (8.7%) 91 75/904 (8.3%) 104
    Investigations
    Lymphocyte count decreased 61/911 (6.7%) 87 15/904 (1.7%) 16
    Neutrophil count decreased 145/911 (15.9%) 210 59/904 (6.5%) 80
    White blood cell count decreased 143/911 (15.7%) 210 52/904 (5.8%) 69
    Metabolism and nutrition disorders
    Decreased appetite 119/911 (13.1%) 135 53/904 (5.9%) 55
    Musculoskeletal and connective tissue disorders
    Arthralgia 84/911 (9.2%) 89 108/904 (11.9%) 119
    Back pain 60/911 (6.6%) 65 73/904 (8.1%) 77
    Myalgia 50/911 (5.5%) 58 49/904 (5.4%) 50
    Pain in extremity 63/911 (6.9%) 75 62/904 (6.9%) 68
    Nervous system disorders
    Dizziness 104/911 (11.4%) 112 67/904 (7.4%) 73
    Dysgeusia 107/911 (11.7%) 125 38/904 (4.2%) 41
    Headache 178/911 (19.5%) 217 151/904 (16.7%) 195
    Psychiatric disorders
    Insomnia 67/911 (7.4%) 71 61/904 (6.7%) 65
    Respiratory, thoracic and mediastinal disorders
    Cough 77/911 (8.5%) 84 72/904 (8%) 80
    Vascular disorders
    Hot flush 72/911 (7.9%) 75 75/904 (8.3%) 77

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Restrictions are imposed by the trial's Steering Committee (SC) and intend to ensure that all publications/presentations are peer reviewed by the SC. Sponsor has the right to review/comment on the content of the material to be published/presented, may request removal of confidential information (e.g. patentable information/trade secrets) within max 90 days. Individual Institutions may publish/present data from their site(s) in compliance with conditions defined in Study Publication Policy.

    Results Point of Contact

    Name/Title Global Clinical Lead
    Organization AstraZeneca
    Phone 1-877-240-9479
    Email information.center@astrazeneca.com
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT02032823
    Other Study ID Numbers:
    • D081CC00006
    • NSABP B-55
    • BIG 6-13
    First Posted:
    Jan 10, 2014
    Last Update Posted:
    Jun 13, 2022
    Last Verified:
    Jun 1, 2022