A Prospective, Multicenter，Phase II Clinical Study of Trastuzumab and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- ORR(objective response rate)
研究概览
简要总结
This trial is a combination of trastuzumab and pyrotinib in the treatment of patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy. A total of 50 patients were enrolled in the study design. Preliminary efficacy and safety in patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Trastuzumab Emtansine for Injection；Pyrotinib Maleate Tablets
Trastuzumab Emtansine for Injection: 3.6 mg/kg body weight (IV), administered on day 1, 21 days as a treatment cycle; Pyrotinib Maleate Tablets: The initial dose is 320 mg (PO), administered orally within 30 minutes after meals, at the same time every day, 21 days as a treatment cycle; Efficacy was assessed every two cycles and treatment was continued until disease progression or intolerable toxicity or death.
干预措施: Trastuzumab Emtansine for Injection (Drug)
Trastuzumab Emtansine for Injection；Pyrotinib Maleate Tablets
Trastuzumab Emtansine for Injection: 3.6 mg/kg body weight (IV), administered on day 1, 21 days as a treatment cycle; Pyrotinib Maleate Tablets: The initial dose is 320 mg (PO), administered orally within 30 minutes after meals, at the same time every day, 21 days as a treatment cycle; Efficacy was assessed every two cycles and treatment was continued until disease progression or intolerable toxicity or death.
干预措施: Pyrotinib Maleate Tablets (Drug)
结局指标
主要结局
ORR(objective response rate)
时间窗: Estimated 24 months
rate of CR and PR in all subjects
次要结局
未报告次要终点