Phase II Open Label Study of Gemcitabine, Paclitaxel and Bevacizumab Combination as First Line Treatment for Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Time-to-Progression (TTP)
研究概览
简要总结
Single-institution phase 2 trial investigating the efficacy of capecitabine, oxaliplatin and bevacizumab for patients with metastatic neuroendocrine tumors.
详细描述
This study will evaluate the time-to-progression (TTP) in patients with metastatic breast cancer, receiving 1st line therapy with bevacizumab in combination with paclitaxel and gemcitabine.
Secondary objectives will include response rates and overall survival (OS).
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
Phase II 3-drug regimen
Gemcitabine + Paclitaxel + Bevacizumab
干预措施: Gemcitabine (Drug)
Phase II 3-drug regimen
Gemcitabine + Paclitaxel + Bevacizumab
干预措施: Paclitaxel (Drug)
Phase II 3-drug regimen
Gemcitabine + Paclitaxel + Bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Time-to-Progression (TTP)
时间窗: 2 years
Time-to-Progression (TTP) was assessed as the time from start of treatment to progression, as observed on radiographic scans and assessed per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for progressive disease (ie, a 5-mm absolute increase of the sum of the longest diameters of the target lesions in addition to a 20% increase in the sum of the target lesions)
次要结局
- Response Rates(24 weeks)
- Overall Survival (OS), Confirmed(6 years)
- Overall Survival (OS), All Participants(6 years)
研究者
George Albert Fisher
Associate Professor of Medicine
Stanford University