Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-02-21 @ 1:34 AM
Study NCT ID:
NCT03708432
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2018-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
500mg Fulvestrant in HR+ MBC
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-23', 'studyFirstSubmitDate': '2018-10-13', 'studyFirstSubmitQcDate': '2018-10-13', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '6 weeks', 'description': 'Progression free survival'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '33022852', 'type': 'DERIVED', 'citation': 'Zhao Y, Li Y, Gong C, Xie Y, Zhang J, Wang L, Cao J, Tao Z, Wang B, Hu X. Optimal duration of prior endocrine therapy predicts the efficacy of Fulvestrant in a real-world study for patients with hormone receptor-positive and HER2-negative advanced breast cancer. Cancer Med. 2020 Dec;9(23):8821-8831. doi: 10.1002/cam4.3491. Epub 2020 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'To study the real world use of 500mg Fulvestrant in HR+ MBC.', 'detailedDescription': 'An observational, retrospective study of 500mg Fulvestrant in hormone receptor+/HER2- advanced breast cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with ER/PR+，HER2- advanced breast cancer\n2. Advanced breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.\n\n3.500mg Fulvestrant treatment of advanced breast cancer for at least one month, between Jan 2011 and Dec 2015.\n\n4.Available medical history\n\nExclusion Criteria:\n\n1. Incomplete medical history\n2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.'}, 'identificationModule': {'nctId': 'NCT03708432', 'briefTitle': '500mg Fulvestrant in HR+ MBC', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'An Observational, Retrospective Study of 500mg Fulvestrant in Hormone Receptor+/HER2- Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'YOUNGBC-4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fulvestrant', 'description': 'Fulvestrant 500mg per month (D1, D28, q28d), with a loading dose 500mg of first dose at D15'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Biyun Wang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Biyun Wang, MD', 'investigatorAffiliation': 'Fudan University'}}}}