跳至主要内容
临床试验/NCT01150513
NCT01150513已完成2 期

Docetaxel Plus Carboplatin Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer

Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2009年6月最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peng Yuan

Chief Physician

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (1)

Loading locations...

相似试验