NCT01134523Unknown3 期
Phase 3 Study of Regimens Comparison for Breast Cancers of Positive Lymph Nodes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
To compare the efficacy and safety of EC-T and ET regimen as adjuvant treatment of breast cancer patients with positive lymph nodes
详细描述
EC-T regimen: epirubicin 90mg/m2 day1, CTX 600mg/m2, day 1, 21 days per cycle *4cycle. followed by paclitaxel 175mg/m2,d1,21days per cycle, 4 cycle.
ET regimen: epirubicin 75mg/m2 day1,paclitaxel 175mg/m2,d2,21days per cycle, 6 cycle
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with breast cancer after breast cancer surgery with positive lymph nodes age 18-70 years old
排除标准
- •with other malignance disease
研究组 & 干预措施
Group A: EC-T regimen
Active Comparator
干预措施: Epirubicin, CTX, Paclitaxel (Drug)
Group B: ET regimen
Experimental
干预措施: Epirubicin, Paclitaxel (Drug)
结局指标
主要结局
PFS
时间窗: 5 years after all the recuiment
次要结局
- OS(5 years after all the adjuvent treatments)
- Safety(5 years after all the recruiment)
研究者
Binghe Xu
Chief
Chinese Academy of Medical Sciences
研究点 (1)
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