Preservation of Ovarian Function in Young Women Treated With (Neo) Adjuvant Chemotherapy for Breast Cancer: A Randomized Trial Using the Gonadotropin-releasing Hormone (GnRH) Agonist (Triptorelin) During Chemotherapy

Fecha de inicio: 1 de julio de 2004

Inclusion Criteria: DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Early-stage, operable disease * Scheduled to receive adjuvant or neoadjuvant systemic chemotherapy for breast cancer * Hormone receptor status: * Meets 1 of the following criteria: * Estrogen receptor (ER)- OR progesterone receptor (PR)-positive * ER- AND PR-negative * No history of premature ovarian failure PATIENT CHARACTERISTICS: Age * Under 45 Sex * Female Menopausal status * Premenopausal * Follicle-stimulating hormone levels \< 40 IU/L at baseline AND at least 2 menstrual periods within the past 6 months * No first-degree relative menopausal at \< 40 years of age Performance status * Eastern Cooperative Oncology Group \[ECOG\] 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Fertile patients must use effective non-hormonal methods of contraception * No prior osteoporosis or other non-malignant systemic disease that would preclude prolonged follow-up * No known allergies to gonadotrophin-releasing hormone agonists * No other cancer except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No prior chemotherapy Endocrine therapy * At least 2 weeks since prior oral contraceptives * No prior fertility treatment * Clomiphene or pergonal for polycystic ovarian disease allowed * No other concurrent oral or transdermal hormonal therapy, including any of the following: * Estrogen * Progesterone * Androgens * Aromatase inhibitors * Hormone replacement therapy * Oral contraceptives Radiotherapy * No prior ovarian radiotherapy Surgery * No prior bilateral oophorectomy * No plans for oophorectomy or hysterectomy within the next 2 years Other * At least 1 week since prior warfarin Exclusion Criteria: * History of premature ovarian failure * Over 45 years of age * First-degree relative menopausal at \< 40 years of age * Pregnant or nursing * Prior osteoporosis or other non-malignant systemic disease that would preclude prolonged follow-up * Known allergies to gonadotrophin-releasing hormone agonists * Other cancer besides nonmelanoma skin cancer * Prior chemotherapy * Prior ovarian radiotherapy * Prior bilateral oophorectomy