Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2026-01-01 @ 3:57 PM
Study NCT ID:
NCT00681369
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2008-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France
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': 217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-21', 'studyFirstSubmitDate': '2008-05-20', 'studyFirstSubmitQcDate': '2008-05-20', 'lastUpdatePostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate Faslodex therapeutic strategy and treatment duration', 'timeFrame': 'At the end of the study'}, {'measure': 'Describe the characteristics of patients treated with Faslodex', 'timeFrame': 'At the end of the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer', 'fulvestrant', 'longitudinal study', 'France'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'the purpose of this study is to describe the way Faslodex is used in France, in patients suffering from initial breast cancer, that is to evaluate Faslodex treatment duration and to determine patients profile'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007'}, 'identificationModule': {'nctId': 'NCT00681369', 'briefTitle': 'Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France', 'orgStudyIdInfo': {'id': 'NIS-OFR-FAS-2007/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alain FLINOIS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TNS Healthcare - France138, avenue Marx Dormoy92120 Montrouge'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Francisco Sapunar - Medical Science Director', 'oldOrganization': 'AstraZeneca'}}}}