Docetaxel, Carboplatin, Trastuzumab and Bevacizumab (TCH+B) For Early-Stage HER-2/Neu(+) Breast Cancer and Bone Marrow Micrometastases
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Proportion of patients who have a complete response in bone marrow.
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: This clinical trial is studying how well giving docetaxel and carboplatin together with trastuzumab and bevacizumab works in treating patients with stage I, stage II, or stage III breast cancer and bone marrow micrometastases.
详细描述
OBJECTIVES:
Primary
- Determine the clinical response in patients with HER2/neu-positive stage I-III breast cancer and bone marrow micrometastases treated with docetaxel, carboplatin, trastuzumab, and bevacizumab.
Secondary
- Investigate the specific contribution of VEGF and CXCL-12 (SDF-1) signaling to bone marrow support of HER2/neu-positive breast cancer cells.
- Evaluate growth factor and chemokine expression profiles to investigate the potential correlation of expression with patient outcome and frequency of tumor cell clusters (mammospheres with tumor stem cell phenotype) in microenvironment supported cultures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Docetaxel,Carboplatin,Trastuzumab and Bevacizumab
干预措施: bevacizumab (Biological)
Docetaxel,Carboplatin,Trastuzumab and Bevacizumab
干预措施: trastuzumab (Biological)
Docetaxel,Carboplatin,Trastuzumab and Bevacizumab
干预措施: carboplatin (Drug)
Docetaxel,Carboplatin,Trastuzumab and Bevacizumab
干预措施: docetaxel (Drug)
Docetaxel,Carboplatin,Trastuzumab and Bevacizumab
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Proportion of patients who have a complete response in bone marrow.
时间窗: at 4 weeks after completing 6 courses of therapy
次要结局
- Specific contribution of VEGF and CXCL-12 (SDF-1) signaling to bone marrow support of HER2/neu-positive breast cancer cells(pre- and post-treatment)
- Potential correlation of growth factor and chemokine expression with patient outcome and frequency of tumor cell clusters (mammospheres with tumor stem cell phenotype) in microenvironment supported cultures(pre- and post-therapy)