Key clinical point: In women with noninvasive neoplasia of the breast, treatment with low-dose tamoxifen for 3 years continued to prevent breast cancer (BC) recurrence, with an optimal safety profile, for at least 7 years after treatment cessation.
Major finding: After a median follow-up of 9.7 years, fewer cases of both invasive and in-situ BC (hazard ratio [HR] 0.58; log-rank P = .03) and contralateral BC (HR 0.36; P = .025) were reported in the tamoxifen vs placebo group. There was no increase in serious adverse events during tamoxifen therapy.
Study details: Findings are from a 10-year follow-up analysis of the phase 3 TAM-01 trial including 500 women with intraepithelial neoplasia of the breast who were randomly assigned to receive low-dose tamoxifen or placebo.
Disclosures: This study was supported by the Italian Ministry of Health and other sources. The authors declared serving as employees, consultants, or advisors, or receiving honoraria and travel and accommodation expenses from several sources.
Source: Lazzeroni M et al. Randomized placebo controlled trial of low-dose tamoxifen to prevent recurrence in breast noninvasive neoplasia: A 10-year follow-up of TAM-01 study. J Clin Oncol. 2023 (Mar 14). Doi: 10.1200/JCO.22.02900