EC‐DOC.
Methods | Randomised controlled trial Multi‐centre, international Randomisation method not specified Accrual March 2000 to August 2005 Baseline patient and tumour characteristics well balanced |
Participants | Female, premenopausal and postmenopausal Mean age: 51.5 years Operable breast cancer with clear surgical margins 1 to 3 positive lymph nodes Exclusion of metastatic disease HR positive: 78% |
Interventions | ARM 1 (EC‐Doc):
EC × 4 21‐day cycles (epirubicin 90 mg/m², cyclophosphamide 600 mg/m²) followed by docetaxel × 4 21‐day cycles (docetaxel 100 mg/m²) ARM 2 (CEF/CMF): FEC × 6 21‐day cycles (fluorouracil 500 mg/m², epirubicin 100 mg/m², cyclophosphamide 500 mg/m²) or CMF × 6 28‐day cycles (cyclophosphamide 600 mg/m², methotrexate 40 mg/m², fluorouracil 600 mg/m² on days 1 and 8) |
Outcomes | Primary endpoint:
Secondary endpoints:
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Notes | Median follow‐up: 64 months Numbers of events and time‐to‐event data not reported in the abstract (64‐month follow‐up) |