Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 98
- Primary Endpoint
- ovarian failure
Study Overview
Brief Summary
The study is a prospective randomized control clinical trial which is sponsored by the researchers. The purpose of this study is to determine the effectiveness of Gonadotropin-Releasing hormone agonist on ovarian function for premenopausal breast cancer patients during chemotherapy. The premenopausal breast cancer patients will be randomly (1:1) enrolled to receive standard chemotherapy with the GnRH agonist goserelin (goserelin group) or standard chemotherapy without goserelin (chemotherapy alone group). All patients are stratified according to age (<35years vs.36-44years), hormone receptor status (HR+ or ER+ vs.HR- and ER-), chemotherapy regimen(3-4 cycles vs.6-8 cycles, and cyclophosphamide-based vs.noncyclophosphamide).The follow-up time will be at least 2years. The ovarian failure, follicle-stimulating hormone, estradiol and anti-Mullerian hormone, pregnancy outcomes and disease-free and overall survival will be compared between two groups to evaluate the effectiveness of protect against ovarian failure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patients signed the written informed consent.
- •Histologically proven stage I, II, or III breast cancer
- •Must be candidates for adjuvant or neoadjuvant chemotherapy,
- •Must be premenopausal.
- •Trastuzumab is permitted in patients with human epidermal growth factor receptor 2 (HER2) overexpressing tumors.
Exclusion Criteria
- •The patients were previous chemotherapy;
- •Evidence of distant metastases;
- •Other malignancies in the previous 5 years.
- •The patients were using GnRHa, progesterone, stimulate ovulation drugs, oral contraceptives, aromatase inhibitors, intrauterine device with hormone, subcutaneous preparations contraceptive drugs such as hormone drugs and instruments during 3 month preceding the start of chemotherapy.
- •Pregnancy or lactation.
Arms & Interventions
standard chemotherapy with goserelin
standard chemotherapy with the GnRH agonist goserelin
Intervention: goserelin (Drug)
standard chemotherapy with goserelin
standard chemotherapy with the GnRH agonist goserelin
Intervention: standard chemotherapy (Drug)
standard chemotherapy without goserelin
standard chemotherapy without goserelin
Intervention: standard chemotherapy (Drug)
Outcomes
Primary Outcomes
ovarian failure
Time Frame: 2 years
Ovarian failure is defined as amenorrhea for the preceding 6 months and follicle-stimulating hormone (FSH) and E2 levels in the post -menopausal range 2 year after the end of chemotherapy.
Secondary Outcomes
- pregnancy(5 year)
- DFS OS(5 year)
- Time to the resumption of menstrual activity(2 year)
- FSH,E2,AMH(2 year)
- Ovarian dysfunction(1 year)