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临床试验/NCT03708432
NCT03708432已完成不适用

An Observational, Retrospective Study of 500mg Fulvestrant in Hormone Receptor+/HER2- Advanced Breast Cancer

Fudan University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年7月15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
100
试验地点
1
主要终点
PFS

研究概览

简要总结

To study the real world use of 500mg Fulvestrant in HR+ MBC.

详细描述

An observational, retrospective study of 500mg Fulvestrant in hormone receptor+/HER2- advanced breast cancer

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

  • Diagnosed with ER/PR+,HER2- advanced breast cancer
  • Advanced breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
  • 3.500mg Fulvestrant treatment of advanced breast cancer for at least one month, between Jan 2011 and Dec
  • 4.Available medical history

排除标准

  • Incomplete medical history
  • HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.

结局指标

主要结局

PFS

时间窗: 6 weeks

Progression free survival

次要结局

  • 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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