NCT00774241撤回4 期
An Open Label Study of the Effect of First Line Combination Treatment With Avastin and Docetaxel on Disease Response in Patients With Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Response rate, median progression free survival, overall survival
研究概览
简要总结
This single arm study will assess the efficacy and safety of first line combination treatment with Avastin + docetaxel in patients with HER2 negative metastatic breast cancer.Patients will receive Avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6 cycles). The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female patients, >=18 years of age;
- •stage IV, HER2 negative metastatic breast cancer;
- •candidate for taxane-based therapy;
- •ECOG performance status 0-2.
排除标准
- •prior chemotherapy for metastatic breast cancer;
- •concomitant primary malignant disease, except for adequately treated cervical cancer in situ, or basal or squamous cell skin cancer within last 5 years;
- •suspicion of CNS metastasis;
- •clinically significant cardiovascular disease.
研究组 & 干预措施
1
Experimental
干预措施: bevacizumab [Avastin] (Drug)
1
Experimental
干预措施: docetaxel (Drug)
结局指标
主要结局
Response rate, median progression free survival, overall survival
时间窗: Event driven
次要结局
- Adverse events(Throughout study)
研究者
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