Adjuvant Chemotherapy of Breast Cancer: Sequential Chemotherapy vs. Standard Therapy. Prospective Randomised Comparison of 4 x Epirubicin and Cyclophosphamide (EC) --> 4 x Docetaxel (Doc) vs. 6 x CMF / CEF in Patients With 1 to 3 Positive Lymph Nodes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,011
- 试验地点
- 1
- 主要终点
- Comparison of event-free survival
研究概览
简要总结
Taxane-based adjuvant chemotherapy is standard in node-positive (N+) early breast cancer (BC). The magnitude of benefit in intermediate-risk N+ early BC is still unclear. West German Study Group and "Arbeitsgemeinschaft Gynäkologische Onkologie" (WSG-AGO) EC-Doc is a large trial evaluating modern sequential taxane-based chemotherapy in the subgroup with 1-3 involved lymph nodes (LN).
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •Age 18-65 years
- •Eastern Cooperative Oncology Group (ECOG) status < 2
- •Surgery: R0-resection and >= 10 removed axillary lymph nodes
- •M0 by chest x-ray, bone scintigraphy and liver sonography
排除标准
- •Polyneuropathy
- •Creatinin (serum) > 1,4 mg/dl; Bilirubin (serum) > 2,0 mg/dl
- •Cardia dysfunction, ejection fraction < lower normal value of each institution
- •Hematopoeitic insufficiency: leucocytes < 3,5 G/l, thrombocytes < 100 G/l
- •second malignant neoplasia, except curatively treated basalioma of the skin
- •Surgery before more the six weeks (42 days)
- •Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
- •Breast feeding woman
- •Sequential breast cancer
- •Reasons indicating risk of poor compliance
- •Patients not able to consent
研究组 & 干预措施
EC-Doc
4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks
干预措施: Epirubicin (Drug)
EC-Doc
4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks
干预措施: Cyclophosphamide (Drug)
EC-Doc
4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks
干预措施: Docetaxel (Drug)
CMF/CEF
6 cycles cyclophosphamide, methotrexate, 5-fluorouracil (CMF) (600/40/600) i.v., day 1 + 8, q = 4 weeks or 6 cycles cyclophosphamide, epirubicin, 5-fluorouracil (CEF) (500/100/500) i.v., day 1, q = 3 weeks
干预措施: Epirubicin (Drug)
CMF/CEF
6 cycles cyclophosphamide, methotrexate, 5-fluorouracil (CMF) (600/40/600) i.v., day 1 + 8, q = 4 weeks or 6 cycles cyclophosphamide, epirubicin, 5-fluorouracil (CEF) (500/100/500) i.v., day 1, q = 3 weeks
干预措施: Cyclophosphamide (Drug)
CMF/CEF
6 cycles cyclophosphamide, methotrexate, 5-fluorouracil (CMF) (600/40/600) i.v., day 1 + 8, q = 4 weeks or 6 cycles cyclophosphamide, epirubicin, 5-fluorouracil (CEF) (500/100/500) i.v., day 1, q = 3 weeks
干预措施: Methotrexate (Drug)
CMF/CEF
6 cycles cyclophosphamide, methotrexate, 5-fluorouracil (CMF) (600/40/600) i.v., day 1 + 8, q = 4 weeks or 6 cycles cyclophosphamide, epirubicin, 5-fluorouracil (CEF) (500/100/500) i.v., day 1, q = 3 weeks
干预措施: 5-fluorouracil (Drug)
结局指标
主要结局
Comparison of event-free survival
时间窗: 60 months after end of treatment
次要结局
- Comparison of overall survival(60 months after end of treatment)
- Comparison of toxicity (measured as number of adverse events)(60 months after end of treatment)
- Comparison of quality of life(60 months after end of treatment)
- Comparison of cost effectiveness across the applied regimens in relation to event-free survival(60 months after end of treatment)