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

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

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).

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