Role of luteinizing hormone-releasing hormone analog (LHRHa) triptorelin (T) in preserving ovarian function during chemotherapy for early breast cancer patients: Results of a multicenter phase III trial of Gruppo Italiano Mammella (GIM) group.

528 Background: To evaluate the role of LHRHa-induced ovarian suppression in preserving the ovarian function (OF) during chemotherapy (CT), a phase III trial was carried out. Methods: Main eligibility criteria: stage I-III premenopausal BC patients (pts), age 18 to 45; hormone receptor (HR) status positive or negative. Arm A: CT alone; arm B: CT + T. T (supplied by Ipsen, Italy) was given every 4 wks during all CT cycles. Allowed CT regimens: CEF or EC (cyclophosphamide, epirubicin, fluorouracil); A (doxorubicin) C; CEF or EC followed by paclitaxel or docetaxel; A or E followed by CMF; CMF. Pts with HR+ tumor received tamoxifen after CT. Primary endpoint: incidence of early menopause (defined by postmenopausal levels of both FSH and estradiol [E2] and no menstrual activity) 1 yr after the end of CT. Study design: multicenter, open-label, randomized, phase III trial. Assuming an incidence of permanent menopause of 60%, for alpha = 0.05 (2-sided) and beta = 0.1 (90% power), 140 pts per arm were needed to de...