Ibrance Real World Insights

Study Overview
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Brief Summary
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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.

Official Title
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TREATMENT PATTERNS AND CLINICAL OUTCOMES AMONG PATIENTS RECEIVING PALBOCICLIB COMBINATIONS FOR HR+/HER2- ADVANCED/METASTATIC BREAST CANCER IN REAL WORLD SETTINGS

Conditions
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Malignant Neoplasm of Breast

Participation Criteria
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Eligibility Criteria
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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).
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer Patients<br>HR+/HER2- advanced/metastatic breast cancer patients across multiple countries. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Progression Free Survival (PFS) at 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 12 months based on the Kaplan-Meier estimate were reported. | Day 1 of palbociclib combination treatment up to Month 12 (data recorded during 4 years of retrospective observation period) | 
| Percentage of Participants With Progression Free Survival at Month 24 | 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. | Day 1 of palbociclib combination treatment up to Month 24 (data recorded during 4 years of retrospective observation period) | 
| Percentage of Participants With Objective Response Rate (ORR) | 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. | From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period) | 
| Percentage of Participants Alive After 1 Year Post Palbociclib Treatment Initiation | 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. | 1 Year (Month 12) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period) | 
| Percentage of Participants Alive After 2 Years Post Palbociclib Treatment Initiation | 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. | 2 years (Month 24) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic breast cancer, advanced breast cancer, HR+/ HER2-