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临床试验/NCT05594082
NCT05594082进行中(未招募)不适用

Real-world Effectiveness and Safety Study of T-Dxd in Chinese Metastatic Breast Cancer.

Fudan University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年11月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150
试验地点
1
主要终点
PFS

研究概览

简要总结

The aim of this trial is to explore the real-world effectiveness and poteintial predictors in Chinese metastatic breast cancer patients.

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

  • Patients aged over 18 years old.
  • Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
  • Plan to receive or has received Trastuzumab Deruxtecan monotherapy
  • Available medical history.

排除标准

  • Incomplete medical history.
  • Pregnancy or breast-breeding

结局指标

主要结局

PFS

时间窗: 6 weeks

progression-free survival

次要结局

  • ORR(6 weeks)
  • OS(6 weeks)
  • CBR(6 weeks)
  • 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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