IRIS: Ibrance Real World Insights

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03159195
• Collaborator: (none)
• Enrollment: 652
• Location: 1
• Actual Duration (Months): 48.4
• Patients Per Site Per Month: 13.5

Study Details

Study Description

Brief Summary

To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments in line with regional licensed indications in real world settings across multiple countries.

Condition or Disease	Intervention/Treatment	Phase
Malignant Neoplasm of Breast

Study Design

• Study Type: Observational
• Actual Enrollment: 652 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: TREATMENT PATTERNS AND CLINICAL OUTCOMES AMONG PATIENTS RECEIVING PALBOCICLIB COMBINATIONS FOR HR+/HER2- ADVANCED/METASTATIC BREAST CANCER IN REAL WORLD SETTINGS
• Actual Study Start Date: Jun 12, 2017
• Actual Primary Completion Date: Jul 23, 2020
• Actual Study Completion Date: Jun 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Breast Cancer Patients HR+/HER2- advanced/metastatic breast cancer patients across multiple countries.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Progression Free Survival (PFS) at Month 12 [Day 1 of palbociclib combination treatment up to Month 12 (data recorded during 4 years of retrospective observation period)]

   PFS was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) while on palbociclib, 2) death, 3) start of a new therapy line after final palbociclib dose, if the reason for discontinuation of palbociclib was disease progression, or 4) last available follow-up, whichever occurred first. Participants who did not experience a progression event (items 1, 2 and 3) were censored at date of last available follow-up. PFS (in months) was calculated as (first event date - palbociclib initiation date + 1)/30.4. Progressive disease - An increase in visible disease and/or presence of any new lesions; included cases where the clinician indicated progressive disease. Percentage of participants with PFS events at 12 months based on the Kaplan-Meier estimate were reported.

2. Percentage of Participants With Progression Free Survival at Month 24 [Day 1 of palbociclib combination treatment up to Month 24 (data recorded during 4 years of retrospective observation period)]

   PFS was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) while on palbociclib, 2) death, 3) start of a new therapy line after final palbociclib dose, if the reason for discontinuation of palbociclib was disease progression, or 4) last available follow-up, whichever occurred first. Participants who did not experience a progression event (items 1, 2 and 3) were censored at date of last available follow-up. PFS (in months) was calculated as (first event date - palbociclib initiation date + 1)/30.4. Progressive disease - An increase in visible disease and/or presence of any new lesions; included cases where the clinician indicated progressive disease. Percentage of participants with PFS events at 24 months based on the Kaplan-Meier estimate were reported.

3. Percentage of Participants With Objective Response Rate (ORR) [From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)]

   ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) on palbociclib combination therapy according to the RECIST version 1.1 recorded from first dose of study treatment until disease progression due to any cause. Complete response: complete resolution of all visible disease. Partial response: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.

4. Percentage of Participants Alive After 1 Year Post Palbociclib Treatment Initiation [1 Year (Month 12) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period)]

   Percentage of participants alive from date of initiation of palbociclib treatment through up to 2 or above progression-based lines of therapy were recorded and reported in this outcome measure. Percentage of participants who alive after 1 year post Palbociclib treatment initiation were based on the Kaplan-Meier estimate.

5. Percentage of Participants Alive After 2 Years Post Palbociclib Treatment Initiation [2 years (Month 24) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period)]

   Percentage of participants alive from date of initiation of palbociclib treatment through up to 2 or above progression-based lines of therapy were recorded and reported in this outcome measure. Percentage of participants who alive after 2 years post Palbociclib treatment initiation were based on the Kaplan-Meier estimate.

Other Outcome Measures

1. Percentage of Participants With Clinical Benefit Rate (CBR) [From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)]

   CBR was defined as the percentage of participants who achieved complete (where 'complete response' was recorded at any time on treatment) or partial response (where 'partial response' was recorded at any time on treatment), or stable disease at greater than equal to (>=) 24 weeks on palbociclib combination therapy. Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Complete response - Complete resolution of all visible disease. Partial response - Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.

2. Percentage of Participants With Best Overall Response [From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)]

   Best overall response was defined as the percentage of participants who achieved complete (where 'complete response' was recorded at any time on treatment), partial response (where 'partial response' was recorded at any time on treatment) and stable disease at greater than equal to (>=) 24 weeks on palbociclib combination therapy. Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Physician inclusion criteria

• Oncologist or gynecologist

• Responsible for treating a minimum of ≥2-6 (depending on country) ABC/MBC patients who meet the eligibility criteria.

• Agrees to participate in the study and complete the eCRFs within the data collection period.

Patient inclusion criteria

• Female

• ≥18 years old.

• HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.

• Received palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licenced indication(s).

• No prior or current enrolment in an interventional clinical trial for ABC/MBC.

• Minimum of three months of follow up data since palbociclib with fulvestrant initiation, or minimum of six months of follow up data since palbociclib with letrozole/aromatase inhibitor initiation (core medical record review).

• Minimum of three months of follow up data since palbociclib initiation (German interim medical record review only).

• Inoperable or recurrent breast cancer (Japan only)

Exclusion criteria:

Physician exclusion criteria

• Qualified less than 2 years ago or more than 35 years ago

• Participated in observational research for ABC/MBC in the last 3 months

• Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor in line with the licenced indication(s).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer, Inc.	New York	New York	United States	10017

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Nov 25, 2019
• Statistical Analysis Plan - Oct 4, 2019

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: NCT03159195
• Other Study ID Numbers: A5481090; IRIS
• First Posted: May 18, 2017
• Last Update Posted: Jun 1, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer: metastatic breast cancer; advanced breast cancer; HR+/ HER2-
• Additional relevant MeSH terms: Neoplasms; Breast Neoplasms

Study Results

Participant Flow

Pre-assignment Detail	Participants who received palbociclib plus aromatase inhibitor (P + AI) or palbociclib plus fulvestrant (P + FV) as treatment of hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (ABC/MBC) in April 2017 or later, were observed retrospectively for treatment patterns and clinical outcomes.

Arm/Group Title	Palbociclib + Aromatase Inhibitor (AI) (P+AI)	Palbociclib + Fulvestrant (P+FV)
Arm/Group Description	Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.	Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
Period Title: Overall Study
STARTED	360	292
COMPLETED	360	292
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Palbociclib + Aromatase Inhibitor (P+AI)	Palbociclib + Fulvestrant (P+FV)	Total
Arm/Group Description	Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.	Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.	Total of all reporting groups
Overall Participants	360	292	652
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	64.8 (10.4)	63.0 (11.4)	64.0 (10.9)
Sex: Female, Male (Count of Participants)
Female	360 100%	292 100%	652 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White/Caucasian	221 61.4%	170 58.2%	391 60%
African American	70 19.4%	49 16.8%	119 18.3%
Asian	9 2.5%	15 5.1%	24 3.7%
Hispanic/Latino	40 11.1%	31 10.6%	71 10.9%
Other	20 5.6%	27 9.2%	47 7.2%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Progression Free Survival (PFS) at Month 12
Description	PFS was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) while on palbociclib, 2) death, 3) start of a new therapy line after final palbociclib dose, if the reason for discontinuation of palbociclib was disease progression, or 4) last available follow-up, whichever occurred first. Participants who did not experience a progression event (items 1, 2 and 3) were censored at date of last available follow-up. PFS (in months) was calculated as (first event date - palbociclib initiation date + 1)/30.4. Progressive disease - An increase in visible disease and/or presence of any new lesions; included cases where the clinician indicated progressive disease. Percentage of participants with PFS events at 12 months based on the Kaplan-Meier estimate were reported.
Time Frame	Day 1 of palbociclib combination treatment up to Month 12 (data recorded during 4 years of retrospective observation period)

Outcome Measure Data

Analysis Population Description

FAS population included participants aged >=18 years, diagnosed with HR+/HER- breast cancer with confirmed ABC/MBC, received palbociclib + letrozole/AI or palbociclib + fulvestrant in line with the licensed indication, had no prior or current enrolment in an interventional clinical trial for ABC/MBC, had minimum of 3 months of follow up data since palbociclib with fulvestrant initiation, or minimum of 6 months of follow up data since palbociclib with letrozole/AI initiation.

Arm/Group Title	Palbociclib + Aromatase Inhibitor (P+AI)	Palbociclib + Fulvestrant (P+FV)
Arm/Group Description	Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.	Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
Measure Participants	360	292
Number [Percentage of participants]	84.1 23.4%	79.8 27.3%

2. Primary Outcome

Title	Percentage of Participants With Progression Free Survival at Month 24
Description	PFS was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) while on palbociclib, 2) death, 3) start of a new therapy line after final palbociclib dose, if the reason for discontinuation of palbociclib was disease progression, or 4) last available follow-up, whichever occurred first. Participants who did not experience a progression event (items 1, 2 and 3) were censored at date of last available follow-up. PFS (in months) was calculated as (first event date - palbociclib initiation date + 1)/30.4. Progressive disease - An increase in visible disease and/or presence of any new lesions; included cases where the clinician indicated progressive disease. Percentage of participants with PFS events at 24 months based on the Kaplan-Meier estimate were reported.
Time Frame	Day 1 of palbociclib combination treatment up to Month 24 (data recorded during 4 years of retrospective observation period)

Outcome Measure Data

Analysis Population Description

FAS population was analyzed for this outcome measure. Data for this outcome measure for reporting group ''P+FV'' was not collected due to limited time on treatment for participants in this group, data was not available beyond Month 12.

Arm/Group Title	Palbociclib + Aromatase Inhibitor (P+AI)
Arm/Group Description	Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
Measure Participants	360
Number [Percentage of participants]	64.3 17.9%

3. Primary Outcome

Title	Percentage of Participants With Objective Response Rate (ORR)
Description	ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) on palbociclib combination therapy according to the RECIST version 1.1 recorded from first dose of study treatment until disease progression due to any cause. Complete response: complete resolution of all visible disease. Partial response: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Time Frame	From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)

Outcome Measure Data

Analysis Population Description

FAS population included participants aged >=18 years, diagnosed with HR+/HER- breast cancer with confirmed ABC/MBC, received palbociclib + letrozole/AI or palbociclib + fulvestrant in line with the licensed indication, had no prior or current enrolment in an interventional clinical trial for ABC/MBC, had minimum of 3 months of follow up data since palbociclib with fulvestrant initiation, or minimum of 6 months of follow up data since palbociclib with letrozole/AI initiation.

Arm/Group Title	Palbociclib + Aromatase Inhibitor (P+AI)	Palbociclib + Fulvestrant (P+FV)
Arm/Group Description	Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.	Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
Measure Participants	360	292
Number [Percentage of participants]	79.5 22.1%	74.0 25.3%

4. Primary Outcome

Title	Percentage of Participants Alive After 1 Year Post Palbociclib Treatment Initiation
Description	Percentage of participants alive from date of initiation of palbociclib treatment through up to 2 or above progression-based lines of therapy were recorded and reported in this outcome measure. Percentage of participants who alive after 1 year post Palbociclib treatment initiation were based on the Kaplan-Meier estimate.
Time Frame	1 Year (Month 12) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period)

Outcome Measure Data

Analysis Population Description

FAS:participants aged >=18 years, diagnosed with HR+/HER- breast cancer with confirmed ABC/MBC, received P + letrozole/AI or P + FV in line with licensed indication, had no prior or current enrolment in an interventional clinical trial for ABC/MBC, had minimum of 3 months of follow up data since P with FV initiation, or minimum of 6 months of follow up data since P with letrozole/AI initiation. "Overall Number of Participants Analyzed"=participants evaluable for this outcome measure.

Arm/Group Title	Palbociclib + Aromatase Inhibitor (P+AI)	Palbociclib + Fulvestrant (P+FV)
Arm/Group Description	Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.	Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
Measure Participants	354	290
Number [Percentage of participants]	95.1 26.4%	87.9 30.1%

5. Primary Outcome

Title	Percentage of Participants Alive After 2 Years Post Palbociclib Treatment Initiation
Description	Percentage of participants alive from date of initiation of palbociclib treatment through up to 2 or above progression-based lines of therapy were recorded and reported in this outcome measure. Percentage of participants who alive after 2 years post Palbociclib treatment initiation were based on the Kaplan-Meier estimate.
Time Frame	2 years (Month 24) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period)

Outcome Measure Data

Analysis Population Description

FAS population was analyzed for this outcome measure. Data for this outcome measure for reporting group ''P+FV'' was not collected due to limited time on treatment for participants in this group, data was not available beyond Month 12. Here, "Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

Arm/Group Title	Palbociclib + Aromatase Inhibitor (P+AI)
Arm/Group Description	Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
Measure Participants	354
Number [Percentage of participants]	90.1 25%

6. Other Pre-specified Outcome

Title	Percentage of Participants With Clinical Benefit Rate (CBR)
Description	CBR was defined as the percentage of participants who achieved complete (where 'complete response' was recorded at any time on treatment) or partial response (where 'partial response' was recorded at any time on treatment), or stable disease at greater than equal to (>=) 24 weeks on palbociclib combination therapy. Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Complete response - Complete resolution of all visible disease. Partial response - Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Time Frame	From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)

Outcome Measure Data

Analysis Population Description

FAS population included participants aged >=18 years, diagnosed with HR+/HER- breast cancer with confirmed ABC/MBC, received palbociclib + letrozole/AI or palbociclib + fulvestrant in line with the licensed indication, had no prior or current enrolment in an interventional clinical trial for ABC/MBC, had minimum of 3 months of follow up data since palbociclib with fulvestrant initiation, or minimum of 6 months of follow up data since palbociclib with letrozole/AI initiation.

Arm/Group Title	Palbociclib + Aromatase Inhibitor (P+AI)	Palbociclib + Fulvestrant (P+FV)
Arm/Group Description	Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.	Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
Measure Participants	360	292
Number [Percentage of participants]	93.8 26.1%	93.2 31.9%

7. Other Pre-specified Outcome

Title	Percentage of Participants With Best Overall Response
Description	Best overall response was defined as the percentage of participants who achieved complete (where 'complete response' was recorded at any time on treatment), partial response (where 'partial response' was recorded at any time on treatment) and stable disease at greater than equal to (>=) 24 weeks on palbociclib combination therapy. Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.
Time Frame	From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)

Outcome Measure Data

Analysis Population Description

FAS population was analyzed. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Arm/Group Title	Palbociclib + Aromatase Inhibitor (P+AI)	Palbociclib + Fulvestrant (P+FV)
Arm/Group Description	Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.	Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
Measure Participants	356	281
Complete Response	11.0 3.1%	8.5 2.9%
Partial Response	68.5 19%	65.5 22.4%
Stable Disease >=24 Weeks	14.3 4%	11.0 3.8%
Stable Disease <24 Weeks	1.4 0.4%	3.2 1.1%

Adverse Events

Time Frame	Not applicable as safety data was not planned to be collected for the study
Adverse Event Reporting Description	Due to non-interventional nature of the study, safety data was not collected.
Arm/Group Title	Palbociclib + Aromatase Inhibitor (P+AI)		Palbociclib + Fulvestrant (P+FV)
Arm/Group Description	Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.		Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.
All Cause Mortality
	Palbociclib + Aromatase Inhibitor (P+AI)		Palbociclib + Fulvestrant (P+FV)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Palbociclib + Aromatase Inhibitor (P+AI)		Palbociclib + Fulvestrant (P+FV)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Palbociclib + Aromatase Inhibitor (P+AI)		Palbociclib + Fulvestrant (P+FV)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

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.