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临床试验/NCT03159195
NCT03159195已完成不适用

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

Pfizer1 个研究点 分布在 1 个国家目标入组 652 人开始时间: 2017年6月12日最近更新:
适应症

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

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

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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