PACS 04.

Methods	Randomised controlled trial Multi‐centre (82 centres in France and Belgium), open‐label Randomisation method not specified. Stratified according to institution and number of involved nodes Accrual February 2001 to August 2004 Baseline patient and tumour characteristics well balanced
Participants	Female, premenopausal and postmenopausal Age: 18 to 64 years. Median age: 50 Localised, unilateral, operable breast cancer, resected with clear surgical margins Axillary node positive (N1 to 3) Exclusion of metastatic disease
Interventions	Part 1 Arm 1 (FEC) FEC × 6 21‐day cycles (fluorouracil 500 mg/m², epirubicin 100 mg/m², cyclophosphamide 500 mg/m²) Arm 2 (ED) ED × 6 21‐day cycles (epirubicin 75 mg/m², docetaxel 75 mg/m²) Part 2: for patients with HER2/neu‐positive tumours only, secondarily randomised to receive trastuzumab for 1 year or observation Tamoxifen 20 mg/d for 5 years given to all patients with ER and/or PR positive. Radiotherapy given as mandatory following breast‐conserving surgery
Outcomes	Primary endpoint: Progression‐free survival Secondary endpoints: Overall survival Toxicity Quality of life
Notes	Median follow‐up: 59.3 months Clinical Trial Identifier: NCT0054587 (see clinicaltrials.gov/ct2/show/NCT00054587) Number of events for DFS not reported; additional data for OS to be provided with longer follow‐up period

CMF: cyclophosphamide, methotrexate, fluorouracil.
 D: docetaxel.
 DFS: disease‐free survival.
 EC: epirubicin, cyclophosphamide.
 ED: epirubicin, docetaxel.
 ER: oestrogen receptor.
 FAC: fluorouracil, doxorubicin, cyclophosphamide.
 FEC: fluorouracil, epirubicin, cyclophosphamide.
 HR: hormone receptor.
 N: node.
 OS: overall survival.
 PR: progesterone receptor.