Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer

OBJECTIVES: Primary * Determine the protective effect of chemical ovarian suppression using triptorelin on the preservation of ovarian function in premenopausal women with early-stage operable breast cancer undergoing adjuvant or neoadjuvant systemic chemotherapy. Secondary * Determine the rate of chemotherapy-related amenorrhea in patients treated with this drug. * Determine the value of inhibin A and B as alternative markers of premature ovarian failure in patients treated with this drug. * Determine quality of life of patients treated with this drug. * Determine disease-free and overall survival of patients treated with this drug. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (\< 35 years vs 35 to 39 years vs \> 39 years); concurrent neoadjuvant or adjuvant systemic chemotherapy (fluorouracil, epirubicin, and cyclophosphamide \[6 courses\] OR fluorouracil, doxorubicin, and cyclophosphamide \[6 courses\] vs doxorubicin and cyclophosphamide \[AC\] \[4 courses\] vs doxorubicin and cyclophosphamide \[AC\] \[4 courses\] followed by a taxane \[4 courses\]); and hormone receptor status (estrogen receptor \[ER\]- AND progesterone receptor \[PR\]-negative vs ER- OR PR-positive). * Arm I: Beginning within 1-4 weeks before the start of chemotherapy, patients receive triptorelin intramuscularly once monthly for 4-6 months during neoadjuvant or adjuvant systemic chemotherapy. * Arm II: Patients receive neoadjuvant or adjuvant systemic chemotherapy only. Quality of life is assessed at baseline, monthly during treatment, every 6 months for 2 years, and then annually for 3 years. Patients are followed every 6 months for 2 years and then annually for 3 years. PROJECTED ACCRUAL: A total of 138 patients (69 per treatment arm) will be accrued for this study within 35 months.