Phase II Study Evaluating the Efficacy and Tolerance of Bevacizumab (Avastin) in HER2- Inflammatory Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 100
- 试验地点
- 28
- 主要终点
- Complete histologic response rate
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as 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. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab and radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying giving bevacizumab together with chemotherapy before surgery and bevacizumab and radiation therapy after surgery to see how well it works in treating patients with inflammatory breast cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the complete histological response rate in patients with inflammatory HER2-negative breast cancer treated with bevacizumab and concurrent chemotherapy followed by bevacizumab and concurrent hormonal therapy after surgery and radiotherapy.
Secondary
- Evaluate the progression-fee and overall survival of these patients at 3 and 5 years.
- Evaluate the tolerance of bevacizumab in these patients.
- Assess circulating metastatic disease before, during, and after treatment.
- Assess circulating endothelial cells before, during, and after treatment.
- Assess predictive factors of response by genomic and proteomic studies on frozen tumor samples and fluid samples (i.e., serum and plasma).
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
- All
- 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
(FEC / Docetaxel) + Bevacizumab
Neoadjuvant treatment: 4 cycles FEC + Bevacizumab followed by 4 cycles Docetaxel + Bevacizumab Adjuvant: Bevacizumab for 1 year
干预措施: bevacizumab (Biological)
(FEC / Docetaxel) + Bevacizumab
Neoadjuvant treatment: 4 cycles FEC + Bevacizumab followed by 4 cycles Docetaxel + Bevacizumab Adjuvant: Bevacizumab for 1 year
干预措施: cyclophosphamide (Drug)
(FEC / Docetaxel) + Bevacizumab
Neoadjuvant treatment: 4 cycles FEC + Bevacizumab followed by 4 cycles Docetaxel + Bevacizumab Adjuvant: Bevacizumab for 1 year
干预措施: docetaxel (Drug)
(FEC / Docetaxel) + Bevacizumab
Neoadjuvant treatment: 4 cycles FEC + Bevacizumab followed by 4 cycles Docetaxel + Bevacizumab Adjuvant: Bevacizumab for 1 year
干预措施: epirubicin hydrochloride (Drug)
(FEC / Docetaxel) + Bevacizumab
Neoadjuvant treatment: 4 cycles FEC + Bevacizumab followed by 4 cycles Docetaxel + Bevacizumab Adjuvant: Bevacizumab for 1 year
干预措施: fluorouracil (Drug)
结局指标
主要结局
Complete histologic response rate
时间窗: Post surgery
次要结局
- Genomic and proteomic analyses and correlation with histologic response(Post surgery)
- Progression-free survival(3 and 5 years)
- Overall survival(3 and 5 years)
- Predictive factors of response to bevacizumab(3 and 5 years)
- Circulating peripheral cells (circulating endothelial and tumor cells): correlation of initial rate and association with histological response after surgery(Post-surgery)
- Toxicity as assessed by CTCAE v3.0(3 and 5 years)