NCT00467012已完成2 期
Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 5
- 主要终点
- Safety
研究概览
简要总结
To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 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
step 1
Experimental
6 enrollment for 1 cycle(4 weeks)
干预措施: bevacizumab (Drug)
step 1
Experimental
6 enrollment for 1 cycle(4 weeks)
干预措施: Paclitaxel (Drug)
step 2
Experimental
114 enrollment through to meet the stopping criteria
干预措施: bevacizumab (Drug)
step 2
Experimental
114 enrollment through to meet the stopping criteria
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Safety
时间窗: throughout study
Progression-free survival (PFS)
时间窗: event driven
次要结局
- Overall Survival(OS)(event driven)
- Time to Treatment Failure(TTF)(evnt driven)
- Response Rate(RR)(event driven)
研究者
研究点 (5)
Loading locations...
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