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
Overview
- Phase
- Phase 2
- Intervention
- triptorelin
- Conditions
- Breast Cancer
- Sponsor
- University of South Florida
- Enrollment
- 49
- Locations
- 9
- Primary Endpoint
- Time to Resumption of Menses
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect normal ovarian cells from the side effects of chemotherapy.
PURPOSE: This randomized phase II trial is studying how well triptorelin works in preserving ovarian function in premenopausal women who are receiving chemotherapy for early-stage breast cancer.
Detailed Description
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.
Investigators
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:
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
Arms & Interventions
triptorelin
GnRH analogue (triptorelin) during chemotherapy
Intervention: triptorelin
Outcomes
Primary Outcomes
Time to Resumption of Menses
Time Frame: Baseline, end of chemotherapy then 5 years
Ovarian function as assessed by follicle stimulating hormone (FSH) and record of menses every 6 months beginning in month 6 for 2 years and then annually for 3 years
Secondary Outcomes
- Chemotherapy-related Amenorrhea(Baseline, end of chemotherapy then 5 years)