A randomised trial of goserelin versus control after adjuvant, risk-adapted chemotherapy in premenopausal patients with primary breast cancer – GABG-IV B-93

Abstract

GABG-IV B-93 is a prospective, randomised study comparing goserelin ( n = 384) with no further treatment ( n = 392) in hormone receptor (HR)-negative breast cancer patients ( n = 465) after 3 cycles cyclophosphamide, methotrexate, 5-fluorouracil (CMF) for patients with 0–3 positive lymph nodes (LN) or 4 cycles epirubicin, cyclophosphamide (EC) followed by 3 cycles CMF for patients with 4–9 positive LN. After completion of the ZEBRA trial the study was amended to enrol also HR-positive patients with 1–9 + LN ( n = 311). After a median follow-up of 4.7 years neither HR-negative nor HR-positive patients showed a benefit for goserelin. The adjusted estimated hazard ratio for event-free survival in HR-negative patients was 1.01 (goserelin versus control, 95% confidence interval [CI] 0.72–1.42, P = 0.97) and 0.77 in HR-positive patients (95% CI 0.47–1.24, P = 0.27). These results do not support the general use of goserelin after adjuvant chemotherapy in this group of premenopausal patients.