JPRN-jRCT2080223637已完成2 期
Phase 2 study of DS-8201a in subjects with breast cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 230
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Men or women the age of majority in their country
- •2.Has pathologically documented breast cancer that:
- •is unresectable or metastatic
- •has HER2 positive expression confirmed per protocol
- •3.Has an adequate tumor sample
- •4.Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- •5.Has protocol-defined adequate cardiac, renal and hepatic function
- •6.Agrees to follow protocol-defined method(s) of contraception
排除标准
- •1.Has a medical history of myocardial infarction, symptomatic CHF (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
- •2.Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females
- •3.Has a medical history of clinically significant lung disease
研究者
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