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
Overview
- Phase
- Phase 3
- Intervention
- Epirubicin
- Conditions
- Breast Cancer
- Sponsor
- West German Study Group
- Enrollment
- 2011
- Locations
- 1
- Primary Endpoint
- Comparison of event-free survival
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
EC-Doc
4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks
Intervention: Epirubicin
EC-Doc
4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks
Intervention: Cyclophosphamide
EC-Doc
4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks
Intervention: Docetaxel
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
Intervention: Epirubicin
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
Intervention: Cyclophosphamide
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
Intervention: Methotrexate
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
Intervention: 5-fluorouracil
Outcomes
Primary Outcomes
Comparison of event-free survival
Time Frame: 60 months after end of treatment
Secondary Outcomes
- 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)