Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT03575260
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2018-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
500mg Fulvestrant Versus Exemestane in 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': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2018-06-21', 'studyFirstSubmitQcDate': '2018-06-21', 'lastUpdatePostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-10', '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': {'keywords': ['Fulvestrant', 'Exemestane'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '30846408', 'type': 'DERIVED', 'citation': 'Xie Y, Li Y, Zhang Y, Zhang S, Li W, Guan X, Zhao Y, Gong C, Hu X, Zhang J, Cao E, Wang L, Ge R, Wang B. Fulvestrant 500 mg Versus Exemestane in Postmenopausal Women With Metastatic Breast Cancer Resistant to Adjuvant Nonsteroidal Aromatase Inhibitors in Clinical Practice: A Multicenter Retrospective Study. Clin Breast Cancer. 2019 Jun;19(3):e452-e458. doi: 10.1016/j.clbc.2019.01.015. Epub 2019 Feb 7.'}]}, 'descriptionModule': {'briefSummary': '500mg Fulvestrant versus Exemestane in MBC', 'detailedDescription': '500mg Fulvestrant versus Exemestane in Metastatic Breast Cancer (MBC) resistant to adjuvant Non-steroidal Aromatase Inhibitors in clinical practice- a multicenter retrospective study'}, '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\n* Postmenopausal woman, age \\> 18 years old\n* Diagnosed with ER/PR+，HER2- Metastatic Breast Cancer\n* Adjuvant treatment of Non-steroidal Aromatase Inhibitors\n* First line of Metastatic Breast Cancer is 500mg Fulvestrant or Exemestane for at least one month, starting from 2014.01.01-2017.06.01\n* Available medical history\n\nExclusion Criteria:\n\n* Incomplete medical history'}, 'identificationModule': {'nctId': 'NCT03575260', 'briefTitle': '500mg Fulvestrant Versus Exemestane in MBC', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': '500mg Fulvestrant Versus Exemestane in Metastatic Breast Cancer (MBC) Resistant to Adjuvant Non-steroidal Aromatase Inhibitors in Clinical Practice- a Multicenter Retrospective Study', 'orgStudyIdInfo': {'id': 'YOUNGBC-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fulvestrant', 'description': 'Fulvestrant 500 mg on days 0, 14, and 28, and every 28 days thereafter'}, {'label': 'Exemestane', 'description': 'Exemestane 25mg per day'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Biyun Wang, MD', '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'}}}}