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临床试验/NCT06344793
NCT06344793已完成不适用

A Multi-center Study of the Clinical Outcomes Between Initial CDK 4/6 Inhibitor Plus Endocrine Therapy and Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer in Real World Practice

Fudan University1 个研究点 分布在 1 个国家目标入组 608 人开始时间: 2023年5月20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
608
试验地点
1
主要终点
PFS

研究概览

简要总结

A multi-center, real world study to evaluate the clinical outcomes between initial CDK 4/6 Inhibitor plus endocrine therapy and initial chemotherapy in HR positive, HER2 negative unresectable or 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 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • age >= 18 years old;
  • Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between June 2020 to October 2023;
  • Received CDK4/6 inhibitor plus endocrine treatment or chemotherapy as first-line therapy for at least one cycle;
  • Complete medical history was available.

排除标准

  • 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(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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