Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT02483767
Status:
COMPLETED
Last Update Posted:
2017-10-17
First Post:
2015-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017273', 'term': 'Goserelin'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}], 'ancestors': [{'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-14', 'studyFirstSubmitDate': '2015-06-09', 'studyFirstSubmitQcDate': '2015-06-24', 'lastUpdatePostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ovarian failure', 'timeFrame': '2 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Ovarian dysfunction', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Time to the resumption of menstrual activity', 'timeFrame': '2 year', 'description': 'Time to the resumption of menstrual activity will be assessed at 3month，1 year and 2year after the end of chemotherapy.'}, {'measure': 'pregnancy', 'timeFrame': '5 year', 'description': 'whether pregnancy will be accessed at 1year, 2year, 3year, 4year, 5year after the end of chemotherapy'}, {'measure': 'DFS OS', 'timeFrame': '5 year', 'description': 'Disease free survival (DFS) and overall survival (OS) will be assessed at 5years after the end of chemotherapy.'}, {'measure': 'FSH,E2,AMH', 'timeFrame': '2 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Premenopausal Breast Cancer', 'Preservation of Ovarian Function', 'Gonadotropin-Releasing Hormone Agonist'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients signed the written informed consent.\n* Histologically proven stage I, II, or III breast cancer\n* Must be candidates for adjuvant or neoadjuvant chemotherapy,\n* Must be premenopausal.\n* Trastuzumab is permitted in patients with human epidermal growth factor receptor 2 (HER2) overexpressing tumors.\n\nExclusion Criteria:\n\n* The patients were previous chemotherapy;\n* Evidence of distant metastases;\n* Other malignancies in the previous 5 years.\n* 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.\n* Pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT02483767', 'acronym': 'POF', 'briefTitle': 'Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer', 'orgStudyIdInfo': {'id': 'PUMCH-BC-ovarian suppression'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'standard chemotherapy with goserelin', 'description': 'standard chemotherapy with the GnRH agonist goserelin', 'interventionNames': ['Drug: goserelin', 'Drug: standard chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard chemotherapy without goserelin', 'description': 'standard chemotherapy without goserelin', 'interventionNames': ['Drug: standard chemotherapy']}], 'interventions': [{'name': 'goserelin', 'type': 'DRUG', 'otherNames': ['Gonadotropin-Releasing Hormone Agonist'], 'description': 'Gonadotropin-Releasing Hormone Agonist', 'armGroupLabels': ['standard chemotherapy with goserelin']}, {'name': 'standard chemotherapy', 'type': 'DRUG', 'otherNames': ['AC-P', 'TC', 'TA', 'TAC', 'FAC followed by T', 'AC'], 'description': '(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;', 'armGroupLabels': ['standard chemotherapy with goserelin', 'standard chemotherapy without goserelin']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}