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临床试验/EUCTR2010-024454-10-GB
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

Boehringer Ingelheim0 个研究点目标入组 30 人开始时间: 2011年4月18日最近更新:
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

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