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

West German Study Group

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Methotrexate; Drug: Epirubicin; Drug: 5-fluorouracil; Drug: Docetaxel; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT02115204

EC-Doc

Details and patient eligibility

About

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).

Enrollment: 2,011 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,011 participants in 2 patient groups

EC-Doc

Experimental group

Description:

4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks

Treatment:

Drug: Docetaxel

Drug: Cyclophosphamide

Drug: Epirubicin

CMF/CEF

Active Comparator group

Description:

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

Treatment:

Drug: 5-fluorouracil

Drug: Methotrexate

Drug: Cyclophosphamide

Drug: Epirubicin