EUCTR2010-024454-10-GB进行中(未招募)不适用
An open label, phase II trial of afatinib with or without vinorelbine forthe treatment of HER2-overexpressing Inflammatory Breast Cancer
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
- •2. Locally advanced or metastatic disease
- •3. Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)
- •4. For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment
- •5. Investigator-confirmed diagnosis of Inflammatory Breast Cancer
- •6. Must have biopsiable disease
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •1. Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population)
- •2. Must not have received prior vinorelbine treatment
研究者
相似试验
Unknown
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