Clinical Trial: Long-term Follow-up of the TAM-01 Study, a Phase III Trial of Low Dose Tamoxifen in Breast DCIS and Premalignant Disease

U.S., May 22 -- ClinicalTrials.gov registry received information related to the study (NCT06982313) titled 'Long-term Follow-up of the TAM-01 Study, a Phase III Trial of Low Dose Tamoxifen in Breast DCIS and Premalignant Disease' on May 13.

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 w...