Goserelin versus control after adjuvant, risk-adapted chemotherapy in premenopausal patients with breast cancer. GABG trial IV-B-93

588 Background: The role of medical ablation after adjuvant chemotherapy in endocrine sensitive or non-sensitive tumors is not yet clearly defined. Methods: We initiated a prospective, randomized multicenter study comparing goserelin (3.6 mg every 28 days for 2 years) and control after adjuvant chemotherapy consisting of three cycles of CMF (500/40/600 mg/m2, i.v. on days 1, 8 q 29) in patients with 0–3+ lymph nodes (LN) and four cycles of EC (90/600 mg/m2, i.v. day 1 q 22) followed by 3 x CMF in patients with 4–9+ LN. At first only patients with hormone receptor (HR)-negative breast cancer were included. However, the study was extended to patients with HR-positive breast cancer and 1–9+ LN, when the ZEBRA study was closed. Results: 776 patients were included (goserelin: n=384; control: n=392), 60% had negative HR, 40% were LN-, 23% had 4–9+ LN; 30% of the patients were 40 years or younger, and 60% received breast conserving surgery. 215 events were observed after a median follow-up of 4.7 years. The firs...