NSABP B-14 — A Randomized Clinical Trial Evaluating Tamoxifen in the Treatment of Patients With Node-Negative Breast Cancer Who Have Estrogen-Receptor-Positive Tumors

Phase 3 · 1989 · Breast Cancer

Design

Randomized, double-blind, placebo-controlled trial comparing 5 years of adjuvant tamoxifen versus placebo after primary surgery.

Population

Women with node-negative, estrogen-receptor-positive breast cancer following surgery.

Primary Endpoint

Disease-free survival

Key Result

Tamoxifen significantly improved 4-year disease-free survival (83% vs 77%; P<0.00001), reducing recurrence and contralateral breast cancer.

Guideline Impact

Adopted into NCCN/ASCO adjuvant endocrine therapy guidelines