Trial Outcomes & Findings for Ibrance Real World Insights (NCT NCT03159195)
NCT ID: NCT03159195
Last Updated: 2025-07-01
Results Overview
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.
COMPLETED
652 participants
Day 1 of palbociclib combination treatment up to Month 12 (data recorded during 4 years of retrospective observation period)
2025-07-01
Participant Flow
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.
Participant milestones
| Measure |
Palbociclib + Aromatase Inhibitor (AI) (P+AI)
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.
|
Palbociclib + Fulvestrant (P+FV)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
360
|
292
|
|
Overall Study
COMPLETED
|
360
|
292
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ibrance Real World Insights
Baseline characteristics by cohort
| Measure |
Palbociclib + Aromatase Inhibitor (P+AI)
n=360 Participants
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.
|
Palbociclib + Fulvestrant (P+FV)
n=292 Participants
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
n=652 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
63.0 Years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
64.0 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
360 Participants
n=5 Participants
|
292 Participants
n=7 Participants
|
652 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · White/Caucasian
|
221 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
391 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · African American
|
70 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Asian
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Hispanic/Latino
|
40 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Other
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 of palbociclib combination treatment up to Month 12 (data recorded during 4 years of retrospective observation period)Population: 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.
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.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor (P+AI)
n=360 Participants
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.
|
Palbociclib + Fulvestrant (P+FV)
n=292 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Progression Free Survival (PFS) at Month 12
|
84.1 Percentage of participants
|
79.8 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 of palbociclib combination treatment up to Month 24 (data recorded during 4 years of retrospective observation period)Population: 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.
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.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor (P+AI)
n=360 Participants
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.
|
Palbociclib + Fulvestrant (P+FV)
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.
|
|---|---|---|
|
Percentage of Participants With Progression Free Survival at Month 24
|
64.3 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)Population: 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.
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.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor (P+AI)
n=360 Participants
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.
|
Palbociclib + Fulvestrant (P+FV)
n=292 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Objective Response Rate (ORR)
|
79.5 Percentage of participants
|
74.0 Percentage of participants
|
PRIMARY outcome
Timeframe: 1 Year (Month 12) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period)Population: 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.
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.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor (P+AI)
n=354 Participants
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.
|
Palbociclib + Fulvestrant (P+FV)
n=290 Participants
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.
|
|---|---|---|
|
Percentage of Participants Alive After 1 Year Post Palbociclib Treatment Initiation
|
95.1 Percentage of participants
|
87.9 Percentage of participants
|
PRIMARY outcome
Timeframe: 2 years (Month 24) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period)Population: 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.
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.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor (P+AI)
n=354 Participants
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.
|
Palbociclib + Fulvestrant (P+FV)
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.
|
|---|---|---|
|
Percentage of Participants Alive After 2 Years Post Palbociclib Treatment Initiation
|
90.1 Percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)Population: 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.
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.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor (P+AI)
n=360 Participants
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.
|
Palbociclib + Fulvestrant (P+FV)
n=292 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Clinical Benefit Rate (CBR)
|
93.8 Percentage of participants
|
93.2 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)Population: FAS population was analyzed. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor (P+AI)
n=356 Participants
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.
|
Palbociclib + Fulvestrant (P+FV)
n=281 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Best Overall Response
Complete Response
|
11.0 Percentage of participants
|
8.5 Percentage of participants
|
|
Percentage of Participants With Best Overall Response
Partial Response
|
68.5 Percentage of participants
|
65.5 Percentage of participants
|
|
Percentage of Participants With Best Overall Response
Stable Disease >=24 Weeks
|
14.3 Percentage of participants
|
11.0 Percentage of participants
|
|
Percentage of Participants With Best Overall Response
Stable Disease <24 Weeks
|
1.4 Percentage of participants
|
3.2 Percentage of participants
|
Adverse Events
Palbociclib + Aromatase Inhibitor (P+AI)
Palbociclib + Fulvestrant (P+FV)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER