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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: West German Study Group
• Collaborator: AGO Germany
• Treatments: Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil; Methotrexate

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

• Patients not able to consent