NCT01956552终止不适用
Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 130
- 试验地点
- 12
- 主要终点
- To assess the phenotype ant genotype discrepancies regarding hormonal receptor, FISH status and proliferation between the primary tumor and the first metastatic progression.
研究概览
简要总结
The primary objective is to compare the phenotype and genotype of the primary tumor with those of its metastases in order to optimize the treatment of metastatic disease, in patients presenting with first metastatic progression of breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •To be eligible to participate in the study, patients must fulfill all of the following criteria:
- •Female patients. Age ≥ 18 years. ECOG performance status ≤
- •Metastatic breast carcinoma, either at diagnosis or at first metastatic relapse.
- •Available FFPE +/- frozen primary tumor samples. Evaluable metastatic disease. Metastatic disease outside any previous radiotherapy field (e.g. sub-clavicular or internal mammary lymph nodes).
- •Metastatic disease accessible to either percutaneous or surgical sampling. Signed written informed consent (approved by an Independent Ethics Committee and obtained prior to any study-specific screening procedure).
- •Social and psychological welfare in concordance with compliance to the study.
排除标准
- •To be eligible to participate in the study, patients must fulfill none of the following criteria:
- •Bilateral or multifocal breast cancer. Isolated local or contralateral relapse.
- •Solitary bone and/or brain metastatic disease unless :
- •Metastatic sites eligible for a therapeutic surgery. Metastatic sites sampled for diagnosis purpose. Past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin. Carcinoma in situ of the cervix. Any coagulopathy contraindicating tumor biopsy. Presence of a contraindication to general anesthesia, if required.
结局指标
主要结局
To assess the phenotype ant genotype discrepancies regarding hormonal receptor, FISH status and proliferation between the primary tumor and the first metastatic progression.
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (12)
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