SOFT — Suppression of Ovarian Function Trial: Adjuvant Ovarian Suppression in Premenopausal Breast Cancer

Phase 3 · 2015 · Breast Cancer

Design

Randomized to tamoxifen alone, tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression.

Population

Premenopausal women with HR-positive early breast cancer.

Primary Endpoint

disease-free survival (DFS)

Key Result

8-yr DFS 83.2% (exemestane+OFS) vs 78.9% (tamoxifen alone); OS 91.5% vs 89.5%, with greatest benefit in high-risk/chemotherapy-treated women.

Guideline Impact

NCCN option for premenopausal high-risk HR+ disease