NCT06135194招募中不适用
Efficacy and Safety of T-Dxd in the Treatment of HER2-positive Breast Cancer With Brain Metastases After Prior Pyrotinib Treatment
Beijing 302 Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年4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
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Central neryous system Progression Free Survival，CNS-PFS
研究概览
简要总结
To evaluate the efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(1) Women ≥18 years of age :(2) pathological diagnosis of HER2-positive breast cancer, defined as positive immunohistochemistry detection (+++) or FISH(Fluorescent In Situ Hybridization); (3) Imaging evidence of brain metastases; (4) Progression of brain metastases after prior treatment with pyrotinib, defined as progression of new or pre-existing brain metastases during treatment with pyrotinib; (5)ECOG score ≤3 points; (6) The efficacy of T-DXd should be evaluated at least once after treatment; (7) Bone marrow and organ functions are basically normal; (8) Complete medical records
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
Central neryous system Progression Free Survival，CNS-PFS
时间窗: 3years
The interval from the start of treatment to the onset of disease progression or death from any cause in the intracranial lesions
次要结局
- Overall Response Rate (ORR)for intracranial and extracranial lesions(3years)
- Overall Clinical Benefit Rate (CBR) for intracranial and extracranial lesions(3years)
- Overall survival (Oversall Survival, OS) and security(5years)
研究者
研究点 (1)
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