Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-28 @ 4:44 PM
Study NCT ID:
NCT01501266
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2011-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Faslodex Specific Clinical Experience Investigation
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 660}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-09', 'studyFirstSubmitDate': '2011-12-27', 'studyFirstSubmitQcDate': '2011-12-28', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse drug reactions.', 'timeFrame': '1 year'}, {'measure': 'Incidence of serious adverse events.', 'timeFrame': '1 Year'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse drug reactions with injection site reaction, thromboembolic events and hepatic impairment', 'timeFrame': '1 year'}, {'measure': 'Progression-free survival', 'timeFrame': '6 month'}, {'measure': 'Progression-free survival', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['postmenopausal breast cancer', 'Faslodex', 'cohort'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=590&filename=CSR_Synopsis_D6997C00008.pdf', 'label': 'CSR\\_Synopsis\\_D6997C00008'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=590&filename=D6997C00008Fulvestrant_Specific_Clinical_Experience_Investigation_Protocol_redacted_23February2016.pdf', 'label': 'D6997C00008Fulvestrant\\_Specific\\_Clinical\\_Experience\\_Investigation\\_Protocol\\_redacted\\_23February2016'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm the safety profile such as the frequency of serious adverse events or any unexpected adverse events and overall efficacy of Faslodex for long term treatment in daily clinical practice.', 'detailedDescription': 'MC MD'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with Faslodex for the first time due to postmenopausal breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated with Faslodex for the first time due to postmenopausal breast cancer\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01501266', 'briefTitle': 'Faslodex Specific Clinical Experience Investigation', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Faslodex Specific Clinical Experience Investigation for Long-term Use', 'orgStudyIdInfo': {'id': 'D6997C00008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Faslodex'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Akita', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'city': 'Aomori', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 40.81667, 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'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Saga', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Shiga', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.02247, 'lon': 138.13005}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Tochigi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'city': 'Tokushima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tottori', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.24877, 'lon': 134.67796}}, {'city': 'Toyama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'city': 'Wakayama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}, {'city': 'Yamagata', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}, {'city': 'Yamaguchi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.18333, 'lon': 131.46667}}, {'city': 'Yamanashi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.67152, 'lon': 138.69827}}], 'overallOfficials': [{'name': 'Shigeru Yoshida', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca KK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}