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First received: May 13, 2025

Clinical Trial: Long-term Follow-up of the TAM-01 Study and Pooled Analysis of Low-dose Tamoxifen Studies in Non-invasive or Microinvasive Breast Neoplasms

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Breast Cancer Invasive

Study Type: OBSERVATIONAL


Official Title: Long-term Follow-up of the TAM-01 Study, a Phase III Trial of Low-dose Tamoxifen, and Pooled Analysis of Three Studies in Breast DCIS, High-risk Lesions and Microinvasive Disease

Brief Summary: Low-dose tamoxifen (5 mg/day for three years, BabyTam) has emerged as a safer and effective alternative to the standard regimen (20 mg/day), reducing breast cancer recurrence with fewer adverse events.The TAM-01 phase III trial demonstrated a 42% reduction in breast cancer events over ten years compared to placebo in women with ductal carcinoma in situ (DCIS) or high-risk lesions (HRL, ADH, LCIS), supporting its inclusion in clinical guidelines.The phase III TAM-01 trial enrolled 500 women, comparing…

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