Safety and Efficacy Real-world Data of Trastuzumab Deruxtecan and Sacituzumab Govitecan in Patients With Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- The primary endpoint was toxicity rate of each drug
研究概览
简要总结
The study aims to evaluate real-world efficacy and toxicity data of treatment with Trastuzumab deruxtecan (T-DXd), a HER2-targeting ADC and sacituzumab govitecan (SG), a TROP-2-targeting ADC in pretreated patients with advanced breast cancer.
详细描述
Antibody-drug conjugates (ADCs) have significantly changed the therapeutic landscape of advanced breast cancer. Trastuzumab deruxtecan (T-DXd), a HER2-targeting ADC and sacituzumab govitecan (SG), a TROP-2-targeting ADC, recently demonstrated superior efficacy over standard of care treatments depending on breast cancer subtype. The study aims to evaluate real-world efficacy and toxicity data of treatment with T-DXd and SG in pretreated patients with advanced breast cancer.
This study includes a retrospective/prospective multicenter review of medical records of patients with advanced breast cancer who received treatment with T-DXd and SG at Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic/recurrent breast cancer
- •18 years of age
- •Triple-negative (TNBC), HER2-positive and/or hormone receptor positive advanced breast cancer
- •Treatment with an ADC at any of line of treatment
- •Treatment with at least one cycle of T-DXd and/or SG
排除标准
- 未提供
研究组 & 干预措施
Patients treated with trastuzumab deruxtecan or sacituzumab govitecan
Patients with TNBC, HER2-positive and/or hormone receptor positive advanced breast treated with trastuzumab deruxtecan or sacituzumab govitecan
干预措施: Antibody-Drug Conjugates (Drug)
结局指标
主要结局
The primary endpoint was toxicity rate of each drug
时间窗: From the initiation of ADC to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, throughout study completion, up to 24 months
Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
次要结局
- progression-free survival (PFS)(From the date of disease progression to the date of death from any cause or last contact, throughout study completion,up to 24 months)