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临床试验/NCT03541863
NCT03541863已完成不适用

What Comes After Fulvestrant? A Real World Multicenter Retrospective Study-Treatment After Progression of Fulvestrant Among Metastatic Breast Cancer Patients in China

Fudan University1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2017年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
131
试验地点
1
主要终点
PFS

研究概览

简要总结

What Comes After Fulvestrant? A Real World Multicenter Retrospective Study-Treatment After Progression of Fulvestrant Among Metastatic Breast Cancer Patients in China.

详细描述

There is no evidence of treatment after progression of Ful. We retrospectively evaluated HR+, HER2- MBC patients failed on Ful 500mg as first line or second line therapy from 2014 to 2017 in 6 institutions. Treatment pattern, PFS, OS and safety were analyzed to figure out the situation and efficacy of treatment after Fulvestrant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who were treated with Fulvestrant between June 2014 to June 2017 as first line or second line therapy
  • Patients received subsequent treatment after progressing on Fulvestrant for at least one cycle (>1 month)
  • Complete medical history was available

排除标准

  • Subsequent treatment was not standard therapy (cannot be classified into endocrine therapy/ chemotherapy)
  • Medical history was incomplete

结局指标

主要结局

PFS

时间窗: 6 weeks

Progression free survival

次要结局

  • OS(From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Biyun Wang, MD

Professor

Fudan University

研究点 (1)

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