Low-dose tamoxifen to prevent recurrence in breast noninvasive neoplasia: ten-year follow-up of TAM-01

The Italian phase 3 TAM-01 trial randomized women with breast intraepithelial neoplasia to low-dose tamoxifen (5 mg once daily) versus placebo administered for 3 years. Ten-year follow-up of the trial found that among women with noninvasive breast cancer, three years of tamoxifen was associated with significant prevention of recurrence for at least seven years after treatment cessation. No between-group difference in the incidence of serious adverse events was reported during the follow-up period.