NCT05834686招募中不适用
An Exploratory Clinical Study of HER2 Expression of Circulating Tumor Cells : Predictive and Prognostic Value in HER2-positive Advanced Breast Cancer Patients Treated With ADC
Beijing 302 Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progression free survival(PFS)
研究概览
简要总结
To evaluate the predictive and prognostic value of HER2 expression of circulating tumor cells in HER2-positive advanced breast cancer patients treated with ADC
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Has pathologically documented breast cancer that:
- •Is unresectable or metastatic
- •has confirmed HER2-positive expression defined as IHC 2+/ISH+ or IHC 3+
- •was previously treated with trastuzumab and taxane in the advanced setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane
- •Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
- •Receives anti-HER2 ADC treatment
- •Life expectancy > 3 months
- •Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection
排除标准
- •Has uncontrolled or significant cardiovascular disease
- •Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- •Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
结局指标
主要结局
Progression free survival(PFS)
时间窗: 3 years
PFS was defined as the time from the start of treatment to either the first documented disease progression or death from any cause
次要结局
- Objective response rate (ORR)(2years)
- Overall survival(OS)(5 years)
研究者
研究点 (1)
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