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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard chemotherapy with goserelin | Experimental | standard chemotherapy with the GnRH agonist goserelin |
|
| standard chemotherapy without goserelin | Active Comparator | standard chemotherapy without goserelin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| goserelin | Drug | Gonadotropin-Releasing Hormone Agonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| ovarian failure | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Ovarian dysfunction | 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. | 1 year |
| Time to the resumption of menstrual activity |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017273 | Goserelin |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| standard chemotherapy | Drug | (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; |
|
|
Time to the resumption of menstrual activity will be assessed at 3month,1 year and 2year after the end of chemotherapy. |
| 2 year |
| pregnancy | whether pregnancy will be accessed at 1year, 2year, 3year, 4year, 5year after the end of chemotherapy | 5 year |
| DFS OS | Disease free survival (DFS) and overall survival (OS) will be assessed at 5years after the end of chemotherapy. | 5 year |
| FSH,E2,AMH | 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. | 2 year |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |