Phase III Randomized Multicenter Trial Comparing Continued Maintenance Therapy With the Bevacizumab + Taxane Versus Bevacizumab + Substituting Exemestane in Patients With Metastatic Breast Cancer or Locally Advanced With Estrogen Receptor Positive and Having at Least a Stable Disease After 16 to 18 Weeks of Treatment With Bevacizumab + Taxane.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Primary free survival
研究概览
简要总结
In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free survival. The investigators make the hypothesis that there would be interest to discontinue treatment with taxane after 4 months, and to begin hormone therapy while continuing maintenance bevacizumab.
Exemestane was chosen because it has been shown potentially active in patients who progressed after letrozole, anastrozole or tamoxifen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age > 18 ans.
- •Metastatic breast cancer or locally advanced
- •RE+, HER2-
- •Patient receiving paclitaxel-bevacizumab first line chemotherapy
排除标准
- •Previous treatment by exemestane (both in adjuvant or metastatic treatment).
- •1st line of chemotherapy different thaan paclitaxel-bevacizumab.
- •Treatment by paclitaxel-bevacizumab > 18 weeks.
- •HER2 positifs et/ou récepteurs aux oestrogènes négatifs.
- •Previous thrombosis event within the 6 months before inclusion .
- •Previous significant surgery within the 28 days before treatment start
- •Previuous coagulopathy.
研究组 & 干预措施
paclitaxel-bevacizumab
Paclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15
干预措施: Paclitaxel (Drug)
paclitaxel-bevacizumab
Paclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15
干预措施: Bevacizumab (Drug)
exemestane-bevacizumab
exemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks
干预措施: Bevacizumab (Drug)
exemestane-bevacizumab
exemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks
干预措施: Exemestane (Drug)
结局指标
主要结局
Primary free survival
时间窗: 24 months for recruitment and 18 months for follow up
次要结局
未报告次要终点