HER2 Heterogeneity and Its Impact on Benefit From Trastuzumab Deruxtecan in Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 28
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of this observational study is to learn about the HER2 heterogeneity and its impact on benefit from trastuzumab deruxtecan in metastatic breast cancer. The main question it aims to answer is:
- Does the heterogeneity of HER2 expression level and spatial distribution in different tissues affect the efficacy of trastuzumab deruxtecan in 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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced or locally unresectable breast cancer;
- •Treated with T-DXd (DS-8201, trastuzumab deruxtecan) regardless of line of therapy, HR, and HER2 expression level;
- •HER2 immunohistochemistry staining information of the primary lesion or metastatic/recurrent lesion;
- •Measurable lesions with treatment response results that can be evaluated through imaging examinations;
- •Able to follow up with the latest progression-free survival or overall survival.
排除标准
- •Patients with missing basic clinical information or HER2 immunohistochemistry staining information;
- •Patients with missing pathological results for both primary and metastatic/recurrent lesions;
- •Patients with no measurable lesions and unable to evaluate T-DXd treatment response;
- •Discontinue T-DXd therapy for unacceptable adverse events or other reasons;
- •Patients lost to follow-up after T-DXd treatment.
研究组 & 干预措施
Trastuzumab Deruxtecan
干预措施: Trastuzumab Deruxtecan (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From date of T-DXd treatment initiation until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 60 months.
Progression-free survival (PFS) is defined as the time from T-DXd treatment initiation to disease progression or death from any cause.
次要结局
- Overall survival (OS)(From date of T-DXd treatment initiation until the date of death from any cause, assessed up to 60 months.)
研究者
Yutian Zou
Assistant Professor
Sun Yat-sen University