POEMS — POEMS/S0230: Goserelin for Ovarian Protection during Breast-Cancer Adjuvant Chemotherapy

Phase 3 · 2015 · Breast Cancer

Design

Randomized phase 3 trial comparing standard cyclophosphamide-containing chemotherapy alone versus chemotherapy plus the LHRH agonist goserelin.

Population

Premenopausal women with operable hormone-receptor-negative (estrogen- and progesterone-receptor-negative) early-stage breast cancer.

Primary Endpoint

Rate of ovarian failure at 2 years

Key Result

Ovarian failure at 2 years occurred in 8% of the goserelin group versus 22% with chemotherapy alone (odds ratio 0.30, 95% CI 0.09-0.97; P=0.04), with more pregnancies and improved disease-free and overall survival in the goserelin group.

Guideline Impact

Incorporated into ASCO fertility-preservation guidance as an option for ovarian protection during chemotherapy