Randomised Comparison of Adjuvant Docetaxel / Cyclophosphamide With Sequential Adjuvant EC / Docetaxel Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,198
- 试验地点
- 1
- 主要终点
- disease-free survival in patients treated with either 6 cycles of Docetaxel / Cyclophosphamide chemotherapy or 4 cycles of EC followed by 4 cycles of Docetaxel as adjuvant treatment
研究概览
简要总结
The planned trial compares an anthracycline-free taxane based regimen versus a modern third generation (anthracycline/taxane-based) regimen in HER2/neu non-over expressing tumors. The aim is to define a further anthracycline-free standard and to spare anthracycline toxicity to a patient, who will only have a modest benefit from this compound. Prior to randomization for chemotherapy for all patients with HR positive disease OncotypeDX® will be performed to identify patients who should not receive chemotherapy.
Secondary objectives of this trial will be to compare overall survival and toxicity between the two chemotherapy arms, to evaluate survival in the observation arm and to perform translational research regarding prognostic and predictive factors.
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 75 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
Epirubicin and Cyclophosphamid followed by Docetaxel
4 cycles of EC on day one every three weeks followed by 4 cycles of Docetaxel on day one every three weeks
干预措施: Docetaxel (Drug)
Epirubicin and Cyclophosphamid followed by Docetaxel
4 cycles of EC on day one every three weeks followed by 4 cycles of Docetaxel on day one every three weeks
干预措施: Epirubicin (Drug)
Epirubicin and Cyclophosphamid followed by Docetaxel
4 cycles of EC on day one every three weeks followed by 4 cycles of Docetaxel on day one every three weeks
干预措施: Cyclophosphamide (Drug)
Combination of Docetaxel and Cyclophosphamid
intravenous infusion on day one every three weeks
干预措施: Cyclophosphamide (Drug)
Combination of Docetaxel and Cyclophosphamid
intravenous infusion on day one every three weeks
干预措施: Docetaxel (Drug)
结局指标
主要结局
disease-free survival in patients treated with either 6 cycles of Docetaxel / Cyclophosphamide chemotherapy or 4 cycles of EC followed by 4 cycles of Docetaxel as adjuvant treatment
时间窗: 5 years
次要结局
未报告次要终点