Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Time to Next Treatment
研究概览
简要总结
A national, multicenter, retrospective, observational study (Real-World Evidence-RWE) aimed to assess the efficacy of Trastuzumab-deruxtecan (T-DXd) in patients with triple-negative (RE<10%) metastatic HER2-Low breast cancer.
详细描述
Data from study DESTINY-04 have established T-DXd as the standard second-line treatment for HER2-Low breast tumors. In that study, about 90% of the population had estrogen-positive receptor (ER+) tumors, under-representing negative ER population. The investigators propose to assess T-DXd efficacy in HER2-Low/ER ≤10% patients in Brazilian population by means of a RWE analysis. Endpoints will be assessment of time to the next treatment, objective response rate, and real-world progression-free survival and real-world overall survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Aged above 18 years old;
- •Have advanced, hormone receptor negative (ER ≤10%), HER2-Low (1+ or 2+/FISH negative) breast cancer;
- •Have been treated with at least one trastuzumab-deruxtecan dose for advanced disease (incurable) as a second or later line;
- •Do not have active CNS metastatic lesions, characterized as stable, asymptomatic lesions and with no targeted treatment for at least 6 months.
排除标准
- •Have been previously treated with trastuzumab-deruxtecan (neoadjuvant, adjuvant, other neoplasms);
- •Have other active neoplasms (except from non-melanoma skin tumors);
- •Have serious or active non-oncology lung diseases;
- •Have other primary and concurrent breast tumor with differing receptor profiles.
研究组 & 干预措施
Trastuzumab-deruxtecan
干预措施: Trastuzumab deruxtecan (Drug)
结局指标
主要结局
Time to Next Treatment
时间窗: Through study completion, an average of 1 year
次要结局
- Response Rate(Through study completion, an average of 18 months)
- Real World Progression Free Survival(Through study completion, an average of 18 months)
- Real World Overall Survival(Through study completion, an average of 18 months)
- Epidemiological Features(Through study completion, an average of 18 months)