NCT00140075已完成3 期
Phase III, Randomized Study Of Epirubicin/Cyclophosphamide Followed By Taxane (Sequential Chemotherapy) Versus Epirubicin/Taxane (Concurrent Chemotherapy) As Adjuvant Treatment For Operable, Node-Positive Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 606
- 试验地点
- 1
- 主要终点
- Disease free survival at 3 years
研究概览
简要总结
The purpose of this study is to compare two combinations of drugs, epirubicin given with a taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to see if one of the combinations is better at preventing or delaying the time for breast cancer recurrence and death after 3 years. The study will also evaluate the side effects of both treatment combinations.
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
- •Breast Cancer Stage T1-3, N1, M0
- •Suitable candidate for anthracycline-containing adjuvant chemotherapy
排除标准
- •Evidence of residual tumor following surgery, or metastatic disease
- •Received prior therapy for breast cancer
研究组 & 干预措施
B
Experimental
ET (8 cycles)
T = docetaxel or paclitaxel
干预措施: Epirubicin with a Taxane (Drug)
A
Experimental
EC (4 cycles) followed by T (4 cycles) for a total of 8 cycles
T = docetaxel or paclitaxel
干预措施: Epirubicin with Cyclophosphamide, followed by a Taxane (Drug)
结局指标
主要结局
Disease free survival at 3 years
时间窗: 3 years
次要结局
- Assess safety in both treatment arms at 3 years(3 years)
- Compare overall survival between the 2 treatment arms at 3 years(3 years)
研究者
研究点 (1)
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