4 x Epirubicin, Cyclophosphamide, Followed by 4 x Docetaxel Versus 6 x CMF / 6 x CEF

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Epirubicin
* Drug: Cyclophosphamide
* Drug: Docetaxel
* Drug: Methotrexate
* Drug: 5-fluorouracil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EC-Doc<br>4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks | Drug: Epirubicin<br> <br> Drug: Cyclophosphamide<br> <br> Drug: Docetaxel<br> <br> |
| Active Comparator: CMF/CEF<br>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 | Drug: Epirubicin<br> <br> Drug: Cyclophosphamide<br> <br> Drug: Methotrexate<br> <br> Drug: 5-fluorouracil<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of event-free survival |  | 60 months after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |