4 x Epirubicin, Cyclophosphamide, Followed by 4 x Docetaxel Versus 6 x CMF / 6 x CEF
Phase 3
Completed
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT02115204
- Lead Sponsor
- West German Study Group
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2011
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EC-Doc Docetaxel 4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks CMF/CEF Epirubicin 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 EC-Doc Epirubicin 4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks EC-Doc Cyclophosphamide 4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks CMF/CEF Cyclophosphamide 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 CMF/CEF Methotrexate 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 CMF/CEF 5-fluorouracil 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
- Primary Outcome Measures
Name Time Method Comparison of event-free survival 60 months after end of treatment
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Ev. Hospital Bethesda
🇩🇪Moenchengladbach, Germany