NCT00191438已完成3 期
Phase III Study of Docetaxel in Combination With Gemcitabine Versus Docetaxel in Combination With Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 7
- 主要终点
- Progression free survival. The final analysis will occur when 250 patients have progressed or died.
研究概览
简要总结
This is a phase III randomized study which compares two different regimens of chemotherapy. The purpose of the study is to determine which of the two regimens will make the tumor smaller or disappear, and for how long. In addition the disease-related symptoms will be evaluated. The safety of the drugs will be determined based upon evaluation of the side effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Locally advanced and/or metastatic breast cancer.
- •Measurable disease
- •Previously treated with anthracycline
排除标准
- •Patients with inflammatory breast disease
结局指标
主要结局
Progression free survival. The final analysis will occur when 250 patients have progressed or died.
次要结局
- Quality of Life
- Overall Survival
- Overall Response Rate
- Time to Treatment Failure
- Overall toxicity
研究者
研究点 (7)
Loading locations...
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