Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer
- Registration Number
- NCT02483767
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 98
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard chemotherapy with goserelin standard chemotherapy standard chemotherapy with the GnRH agonist goserelin standard chemotherapy without goserelin standard chemotherapy standard chemotherapy without goserelin standard chemotherapy with goserelin goserelin standard chemotherapy with the GnRH agonist goserelin
- Primary Outcome Measures
Name Time Method ovarian failure 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 Outcome Measures
Name Time Method pregnancy 5 year whether pregnancy will be accessed at 1year, 2year, 3year, 4year, 5year after the end of chemotherapy
DFS OS 5 year Disease free survival (DFS) and overall survival (OS) will be assessed at 5years after the end of chemotherapy.
Time to the resumption of menstrual activity 2 year Time to the resumption of menstrual activity will be assessed at 3month，1 year and 2year after the end of chemotherapy.
FSH,E2,AMH 2 year FSH, estradiol, and anti-Mullerian hormone (AMH) levels in the postmenopausal range will be assessed at 3month，1 year and 2year after the end of chemotherapy.
Ovarian dysfunction 1 year Ovarian dysfunction is defined as amenorrhea for the preceding 3 months and follicle-stimulating hormone (FSH) and E2 levels in the post -menopausal range 1 year or 2year after the end of chemotherapy.