NCT00740532已完成不适用
Observational Study Assessing Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients
Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2007年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Association of a specific biomarker with response to Herceptin-based therapy
研究概览
简要总结
Aim of the study is to assess the impact on response to Herceptin-based therapy in patients with advanced breast cancer. Tumor specimens from primary breast cancer will be analized for several biological factors potentially involved in Herceptin sensitivity.
Tests that will be performed include: FISH analyses of EGFR, HER-2, HER-3, C-MYC, PTEN, MET, IGFR-1. Immunofluorecence of P95HER2. Mutation analyses of EGFR, HER-2, MET, C-MYC, PTEN, KRAS, PIK3CA, IGFR-1. Immunohistochemistry of the same biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hystological diagnosis of breast cancer
- •Availability of tumor tissue
- •Availability to assess the response to Trastuzumab according to RECIST criteria
- •Availability of clinical data
排除标准
- •Unavailability of tumor tissue
- •Impossibility to assess the response to Trastuzumab according to RECIST criteria
结局指标
主要结局
Association of a specific biomarker with response to Herceptin-based therapy
时间窗: Response after two months of treatment
次要结局
- Association of a specific biomarker with time to progression survival and patient's characteristics(At the end of enrollment)
研究者
研究点 (1)
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