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临床试验/NCT04850625
NCT04850625已完成不适用

Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine in Patients With Previously Treated HER2-Positive Metastatic Breast Cancer: a Multicenter, Retrospective Study

Fudan University1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2020年1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
224
试验地点
1
主要终点
PFS

研究概览

简要总结

Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

详细描述

This is a retrospective study aiming to explore the efficacy and safety of Pyrotinib plus Vinorelbine versus Lapatinib plus Capecitabine in patients with previously treated HER2-positive metastatic 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

  • HER2+ MBC patients scored +3 by immunohistochemical (IHC) analysis or scored +2 and the result of fluorescence in situ hybridization was positive.
  • Patients were previously treated with trastuzumab in the advanced setting and a taxane in any setting.
  • Patients received lapatinib (750-1,250 mg/day) plus capecitabine (1,500-2,000 mg/m2) or pyrotinib (320-400 mg/day) plus vinorelbine (25mg/ m2 intravenously or 60 mg/m2 orally on days 1 and 8 per 21 days) for at least one cycle, starting from Jun 2015 to Jan
  • Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions.

排除标准

  • Incomplete medical history

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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