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Aims: Breast cancer has been considered a more indolent disease in the elderly compared to younger women. The aim of this trial was to test the hypothesis that tamoxifen alone would provide adequate control of breast cancer over the normal expectation of life of an elderly woman, thereby sparing them surgery. Methods: Patients with operable invasive breast cancer aged over 70 were randomized to either tamoxifen alone, 40 mg daily, or surgery plus the same dose of tamoxifen. As the tumour was still in situ in half the patients, the first change of management (COM) was taken to signal primary treatment failure in place of recurrence-free interval. Overall and breast cancer mortality was compared in the two groups. Results: Between 1984 and 1992, 455 patients with operable disease were randomized into the trial. This analysis is based on a median follow-up of 12.3 years. The COM-free interval was significantly shorter in the tamoxifen-alone group (hazard ratio (HR) = 2.80 (95 per cent confidence interval (CI) = 2.09–3.74)) as was the progression-free interval (HR = 4.42(95 per centCI = 3.33–5.87)). For surgery-plus-tamoxifen patients the most frequent intervention was hormonal therapy (51 per cent) whereas for tamoxifen-alone patients it was surgery (64 per cent). The greater hazard ratio for progression-free interval compared to COM-free interval is due to a delay in changing management once patients in the tamoxifen-alone group had evidence of progression. Overall mortality and mortality from breast cancer were significantly increased in the tamoxifen-alone group compared to the surgery-plus-tamoxifen group, HR = 1.3 (95 per cent CI = 1.05–1.61) and HR = 1.75 (95 per cent CI = 1.18–2.59), respectively. Stratification of overall mortality by age and tumour size suggested that patients aged 70–72 or with T3 tumours had an increased mortality when treated with tamoxifen alone compared to surgery-plus-tamoxifen, HR = 2.00 (... [ABSTRACT FROM AUTHOR]