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This trial demonstrated that the addition of radiation therapy to tomoxifen significantly decreased the rate of local relapse in women 50 years of age or older who had T1 or T2 node-negative breast cancer. 769 women with early breast cancer were randomly assigned to receive breast irradiation plus tamoxifen or tamoxifen alone. As compared with tamoxifen alone, radiotherapy plus tamoxifen significantly reduces the risk of breast and auxiliary recurrence after lumpectomy in women with small, node-negative, hormone-receptor-positive breast cancers.