Six‐year results of a controlled trial of tamoxifen as single adjuvant agent in management of early breast cancer

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Abstract
A randomized controlled trial of tamoxifen as a single adjuvant agent after mastectomy for early breast cancer, reported on at an average follow‐up of almost 2 years in 1983, has now been followed up to a maximum of 6 years. One thousand two hundred eighty five patients aged 75 or less were entered into the trial. Premenopausal women with positive axillary nodes and postmenopausal women with both positive and negative axillary nodes were randomized to receive either tamoxifen 10 mg twice daily for 2 years or to the untreated control group with systemic therapy reserved until the time of relapse. Forty‐six percent of the trial population had primary tumor specimens assayed for estrogen receptor (ER) content. There has been a highly significant reduction in death rate, with 45 (34%) fewer deaths observed in the treated group than in the control group. This benefit appeared to be independent of menopausal, nodal, or ER status.