NCT01069796终止2 期
A Multi Phase II Clinical Trials Evaluating the Association of Bevacizumab With Weekly Paclitaxel and Capecitabine in First Line Treatment for Patients With Triple Negative Metastatic or Locally Advanced Cancer
ARCAGY/ GINECO GROUP17 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 64
- 试验地点
- 17
- 主要终点
- objective response rate
研究概览
简要总结
Patients with triple negative metastatic breast cancer (HER2-, PR-, ER-) will receive bevacizumab, paclitaxel and capecitabine as a first line of treatment (possibility to have received adjuvant chemotherapy).
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
- •Female histologically confirmed adenocarcinoma of the breast ER-, PR-, HER2- disease
- •Measurable disease
- •Patients may received prior radiotherapy as adjuvant treatment or/and metastatic disease provided that they have progressive disease at study entry
排除标准
- •Prior chemotherapy for metastatic disease
- •HER2 positive and/or hormonal receptor positive
研究组 & 干预措施
Association bevacizumab paclitaxel capecitabine breast cancer
Experimental
- bevacizumab 10 mg/kg in IV, D1 and D15
- paclitaxel 80mg/m2 in IV, D1 to D8 and D15
- capecitabine 1600mg/m2/D, per os, D1 to D5, Weeks 1,2 and 3
干预措施: Paclitaxel (Drug)
Association bevacizumab paclitaxel capecitabine breast cancer
Experimental
- bevacizumab 10 mg/kg in IV, D1 and D15
- paclitaxel 80mg/m2 in IV, D1 to D8 and D15
- capecitabine 1600mg/m2/D, per os, D1 to D5, Weeks 1,2 and 3
干预措施: Bevacizumab (Drug)
Association bevacizumab paclitaxel capecitabine breast cancer
Experimental
- bevacizumab 10 mg/kg in IV, D1 and D15
- paclitaxel 80mg/m2 in IV, D1 to D8 and D15
- capecitabine 1600mg/m2/D, per os, D1 to D5, Weeks 1,2 and 3
干预措施: Capecitabine (Drug)
结局指标
主要结局
objective response rate
时间窗: 36 months for recrutment and 30 months for follow up
次要结局
未报告次要终点
研究者
研究点 (17)
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