Effect of low-dose tamoxifen on benign gynecological and breast conditions in a phase III trial in non-invasive breast cancer

Journal of the National Cancer Institute Pub Date : 2025-08-29 DOI:10.1093/jnci/djaf250

Alessio Carbone, Martino Oliva, Matteo Puntoni, Aliana Guerrieri-Gonzaga, Irene Maria Briata, Matteo Lazzeroni, Davide Serrano, Livia Giordano, Maria Digennaro, Laura Cortesi, Francesco Millo, Katia Cagossi, Giuseppe Aprile, Patrizia Serra, Elisa Gallerani, Bernardo Bonanni, Andrea DeCensi

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Abstract

Despite the proven efficacy of tamoxifen (T) in breast cancer prevention, its uptake remains limited due to concerns over side effects. A phase III trial showed that low-dose T (5 mg/day for 3 years) significantly reduces recurrence with minimal toxicity. After 10 years of follow-up, we observed no significant differences in benign gynecological or breast events between the tamoxifen and placebo (P) arms. The uterus was the most frequently affected site (30 cases per arm), followed by the breast (18) and ovary (5 vs 3 on T and P, respectively). Endometrial polyps were similarly distributed. Endometrial thickness remained stable in premenopausal women and showed only a mild, non-clinically significant increase in postmenopausal women on T (∼1.5 mm). Compared with data on standard-dose tamoxifen, rates of benign events were lower. These findings reinforce the favorable safety profile of low-dose tamoxifen. ClinicalTrials.gov: NCT01357772.

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低剂量他莫昔芬对非侵袭性乳腺癌III期临床试验中良性妇科和乳腺状况的影响

尽管它莫西芬(T)在预防乳腺癌方面已被证实有效，但由于对副作用的担忧，它的吸收仍然有限。一项III期试验表明，低剂量T治疗（5毫克/天，持续3年）可显著减少复发，毒性最小。经过10年的随访，我们观察到他莫昔芬组和安慰剂组在良性妇科或乳房事件方面没有显著差异。子宫是最常见的受累部位（每臂30例），其次是乳房（18例）和卵巢（分别为5例和3例）。子宫内膜息肉分布相似。绝经前妇女的子宫内膜厚度保持稳定，绝经后妇女在T （~ 1.5 mm）上只有轻微的、非临床显著的增加。与标准剂量的他莫昔芬相比，良性事件的发生率更低。这些发现加强了低剂量他莫昔芬良好的安全性。ClinicalTrials.gov: NCT01357772。

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Journal of the National Cancer Institute

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