NCT01150513已完成2 期
Docetaxel Plus Carboplatin Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Disease Free Survival (DFS) of 3 years
研究概览
简要总结
Triple-negative breast cancer (TNBC) has a relatively bad prognosis whereas there is no standard regimen. Some data showed that platins could improve the efficacy of advance TNBC. In this trial, it is the hypothesis that TP (docetaxel plus carboplatin) has a better efficacy than EC-T (epirubicin plus cyclophosphamide followed by docetaxel).
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
- •Triple-negative breast cancer
- •Older than 18 years old
- •Have tumor resection surgery
- •Sufficient organ function (marrow, heart, liver)
排除标准
- •Other malignancy
- •Other serious disease( marrow, heart, liver)
研究组 & 干预措施
EC-T
Active Comparator
干预措施: EC-T (Drug)
TP
Experimental
干预措施: TP (Drug)
结局指标
主要结局
Disease Free Survival (DFS) of 3 years
时间窗: 3 years after mastectomy
local recurrence, distant metastasis, the secondary primary malignancy
次要结局
- Safety Profiles(Up to 24 weeks)
研究者
Peng Yuan
Chief Physician
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究点 (1)
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