Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
Breast Cancer, Hormone Changes, Drug Toxicity
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring drug/agent toxicity by tissue/organ, hormone changes, stage I breast cancer, stage II breast cancer
Eligibility Criteria
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
Sites / Locations
- CCOP - Bay Area Tumor Institute
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- MBCCOP - Medical College of Georgia Cancer Center
- MBCCOP - JHS Hospital of Cook County
- CCOP - Cancer Research for the Ozarks
- Hulston Cancer Center at Cox Medical Center South
- CCOP - MeritCare Hospital
- CCOP - Scott and White Hospital
- CCOP - Northwest
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
triptorelin
no triptorelin
GnRH analogue (triptorelin) during chemotherapy
No GnRH analogue (triptorelin) during chemotherapy