NCT00845910终止2 期
A Phase II Trial of Evaluating Circulating Endothelial Cell as A Surrogate Marker for Monitoring Treatment Efficacy of Docetaxel Plus Capecitabine With Bevacizumab as First Line Treatment for Patients With Locally Recurrent and Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 22
- 主要终点
- Overall response rate
研究概览
简要总结
This single arm study will evaluate the correlation between circulating endothelial cell levels and treatment efficacy in patients with locally recurrent and metastatic breast cancer given first line treatment with Avastin in combination with docetaxel + Xeloda.Patients will be treated with docetaxel 60mg/m2 iv on day 1, and Xeloda 900mg/m2 po on days 1-14, of each 3 week cycle, plus Avastin 7.5 mg/kg iv on day 1 of each 3 week cycle. 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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients, 18-65 years of age;
- •locally recurrent and metastatic breast cancer;
- •measurable or evaluable disease;
- •ECOG performance status of 0-2;
- •LVEF >=50% without clinical symptoms or signs of heart failure.
排除标准
- •unknown HER2 status, or known HER2-positive status;
- •prior chemotherapy for locally recurrent or metastatic disease;
- •prior adjuvant or neoadjuvant taxane therapy within 12 months prior to start of treatment;
- •clinical or radiological evidence of CNS metastases;
- •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: capecitabine [Xeloda] (Drug)
1
Experimental
干预措施: docetaxel (Drug)
结局指标
主要结局
Overall response rate
时间窗: Every 12 weeks
次要结局
- Time to disease progression(Event driven)
- Serious adverse events(At planned visits, till disease progression)
研究者
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