A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide Versus Doxorubicin and Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment of Operable Breast Cancer HER2neu Negative Patients With Positive Axillary Lymph Nodes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 3,299
- 试验地点
- 2
- 主要终点
- Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival)
研究概览
简要总结
Primary objective :
- To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes.
Secondary objectives :
- To compare toxicity and quality of life between the 2 above-mentioned arms.
- To evaluate pathologic and molecular markers for predicting efficacy.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Doxorubicin in combination with cyclophosphamide followed by docetaxel (AC -> T)
干预措施: Docetaxel,doxorubicin, cyclophosphamide (Drug)
2
Docetaxel in combination with doxorubicin and cyclophosphamide (TAC)
干预措施: docetaxel, doxorubicin, cyclophosphamide (Drug)
结局指标
主要结局
Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival)
时间窗: Median follow-up 65 months
The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
次要结局
- Death From Any Cause (Overall Survival)(Median follow-up of 65 months)