Table 1. Principal inclusion/exclusion criteria.

Inclusion criteria	Exclusion criteria
• Aged over 70 • Male or female • WHO performance status 0 or 1 • Histological diagnosis of early stage invasive breast carcinoma • Primary operable breast cancer surgically treated by wide local excision or mastectomy with clear margins • Axillary staging performed (node-positive patients to have axillary clearance or radiotherapy to the axilla) • Fit to receive chemotherapy • Adequate bone marrow, hepatic and renal function • No active, uncontrolled infection • Written informed consent • Available for routine long-term hospital follow-up	• Previous invasive breast cancer within the last 5 years • Previous DCIS within the last 5 years if treated systemically • Previous haematological malignancy or melanoma • Chemotherapy within the last 5 years • Previous anthracycline chemotherapy at any time • Primary inoperable breast cancer (T4 and/or N3 disease) • Breast-conserving surgery with no plans for postoperative radiotherapy • Previous mantle radiotherapy • Significant cardiac disease • Unable or willing to give informed consent
Changes made in July 2008
High risk of relapse within 5 years ER negative or ER weakly positive (Allred score ⩽5)	Any previous systemic anti-cancer therapy, or any solid tumour in the last 5 years
was changed to	was changed to
High risk (∼30%), includes patients with HER2-positive disease and/or ER-negative disease, or ER positive with grade 3 disease and/or 4+ positive nodes	No previous anthracycline chemotherapy at any time, and no systemic anti-cancer therapy within the last 5 years

Abbreviations: DCIS, ductal carcinoma in situ; ER=oestrogen receptor; WHO=World Health Organization.

Randomisation was as soon as reasonably possible after definitive surgery, ideally within 8 weeks.