TREATMENT PATTERNS AND CLINICAL OUTCOMES AMONG PATIENTS RECEIVING PALBOCICLIB COMBINATIONS FOR HR+/HER2- ADVANCED/METASTATIC BREAST CANCER IN REAL WORLD SETTINGS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 652
- 试验地点
- 1
- 主要终点
- Percentage of Participants Alive After 1 Year Post Palbociclib Treatment Initiation
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants Alive After 1 Year Post Palbociclib Treatment Initiation
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
