Ibrance Real World Insights
- Conditions
- Malignant Neoplasm of Breast
- Registration Number
- NCT03159195
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 652
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer, Inc.
🇺🇸New York, New York, United States