Dissecting the Pathways of Therapy Resistance in Early Breast Cancer: A Sub-study of the EORTC 10041/BIG 3-04 MINDACT Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 5
- 主要终点
- Disease progression
研究概览
简要总结
Within the 1st step MINDACT patients who have already relapsed will be asked to participate. For these patients a biopsy of the metastasis should have been taken. A molecular analysis of the stored primary tumor sample and of the metastatic sample, using new technologies, will be performed, and the characteristics of both samples will be compared.
Within the 2nd step a prospective collection of the metastasis samples will be implemented and analysis of biological material from relapsing MINDACT patients is foreseen.
This process will provide insights on the biology of breast cancer and allow us to better understand mechanisms of resistance to therapies, contributing to overcoming this important problem.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Disease progression
时间窗: 2 years after FPI
Characterization of disease progression using molecular characterization of tumour and germline molecular markers in tissue and blood.
Number of enrolled patients per year with adequate clinicopathologically annotated biological material and clinical data.
时间窗: 2 years after FPI
Collection of tissue from the first site of relapse or new primary breast cancer, and blood samples for patients still alive that have relapsed (retrospective collection) or will relapse (prospective collection)
Treatment resistance
时间窗: 2 years after FPI
Treatment resistance studies aiming to verify if a given mechanism is responsible for the relapse after exposure to anticancer agents will be performed using molecular characterization of tumour and germline molecular markers in tissue and blood..
次要结局
未报告次要终点