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临床试验/NCT05572645
NCT05572645已完成不适用

Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab in 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 333 人开始时间: 2022年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
333
试验地点
1
主要终点
PFS

研究概览

简要总结

Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab

详细描述

This is a retrospective study aiming to explore the efficacy and safety of Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab in patients with 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 received Pyrotinib(320-400 mg, po, qd) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) or Pertuzumab(840mg q3w, and then 420 mg q3w) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) for at least one cycle, starting from Jan 2018 to Sep
  • Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions.

排除标准

  • Incomplete medical history

研究组 & 干预措施

PyroH

treatment based on Pyrotinib(320-400 mg, po, qd) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)

干预措施: Pyrotinib Plus Trastuzumab (Drug)

PertH

treatment based on Pertuzumab(840mg q3w, and then 420 mg q3w) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)

干预措施: Pertuzumab Plus Trastuzumab (Drug)

结局指标

主要结局

PFS

时间窗: 6 weeks

Progression free survival

次要结局

  • Adverse Events(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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