Breast Cancer
Conditions
Keywords
Premenopausal Breast Cancer, Preservation of Ovarian Function, Gonadotropin-Releasing Hormone Agonist
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.
Interventions
DRUGgoserelin
Gonadotropin-Releasing Hormone Agonist
DRUGstandard chemotherapy
(Anthracyclines/cyclophosphamide) followed by paclitaxel or doxetaxel; doxetaxel/cyclophosphamide; doxetaxel or paclitaxel/Anthracyclines; fluorouraci/Anthracyclines/cyclophosphamide followed by doxetaxel or paclitaxel; doxetaxel/Anthracyclines/cyclophosphamide; Anthracyclines/cyclophosphamide;
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Outcome results
None listed