Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: goserelin
* Drug: standard chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard chemotherapy with goserelin<br>standard chemotherapy with the GnRH agonist goserelin | Drug: goserelin<br>* Gonadotropin-Releasing Hormone Agonist<br>* Other names: Gonadotropin-Releasing Hormone Agonist;Drug: standard chemotherapy<br>* (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;<br>* Other names: AC;|
| Active Comparator: standard chemotherapy without goserelin<br>standard chemotherapy without goserelin | Drug: standard chemotherapy<br>* (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;<br>* Other names: AC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premenopausal Breast Cancer, Preservation of Ovarian Function, Gonadotropin-Releasing Hormone Agonist