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. 2019 Sep 2;2019(9):CD004421. doi: 10.1002/14651858.CD004421.pub3

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:
  • Event‐free survival


Secondary endpoints:
  • Overall survival

  • Toxicity

  • Quality of life

Notes Median follow‐up: 64 months
Numbers of events and time‐to‐event data not reported in the abstract (64‐month follow‐up)