TAM-01 Trial Shows 10-Year Follow-up of Low-Dose Tamoxifen Is Effective in Preventing Recurrence of Breast Noninvasive Neoplasia.
A 10-year follow-up study of the TAM-01 trial has shown that low-dose tamoxifen can significantly reduce the risk of recurrence in patients with breast noninvasive neoplasia. The study, which was conducted in Italy and involved 408 patients, found that the group that received tamoxifen had a significantly lower risk of developing invasive breast cancer or ductal carcinoma in situ (DCIS) compared to the placebo group.
The TAM-01 trial was designed to investigate whether low-dose tamoxifen (5 mg/day) could reduce the risk of recurrence in patients with noninvasive breast neoplasia. The initial results, which were published in 2013, showed that tamoxifen reduced the risk of recurrence by 52% compared to placebo.
The 10-year follow-up study confirms the long-term benefits of low-dose tamoxifen. At a median follow-up of 10.9 years, the tamoxifen group had a 50% reduction in the risk of invasive breast cancer or DCIS compared to the placebo group. The risk of contralateral breast cancer was also significantly reduced in the tamoxifen group.
The study also found that low-dose tamoxifen was well-tolerated, with no significant differences in adverse events between the tamoxifen and placebo groups. The authors of the study conclude that low-dose tamoxifen should be considered as a preventive therapy for patients with breast noninvasive neoplasia.