Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-01-04 @ 2:57 AM
Study NCT ID:
NCT00660803
Status:
COMPLETED
Last Update Posted:
2010-01-21
First Post:
2008-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Brazilian Study of Fulvestrant in Advanced 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': 'D000077267', 'term': 'Fulvestrant'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-20', 'studyFirstSubmitDate': '2008-04-15', 'studyFirstSubmitQcDate': '2008-04-15', 'lastUpdatePostDateStruct': {'date': '2010-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to tumour progression'}, {'measure': 'Objective response'}], 'secondaryOutcomes': [{'measure': 'Duration of treatment with fulvestrant'}, {'measure': 'Time and duration of response'}, {'measure': 'Overall survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced Breast Cancer', 'Hormone Therapy'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Characterize the demographic and clinical features, as well as the main treatment results, among patients with advanced breast cancer treated with fulvestrant in Brazil.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hospitals and primary care clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive HR or ER by immunohistochemistry\n* Postmenopausal status at the time of treatment with fulvestrant\n* Failure of at least one previous endocrine therapy before treatment with fulvestrant.\n\nExclusion Criteria:\n\n* Patients who are still undergoing treatment with fulvestrant will not be eligible to participate in the study'}, 'identificationModule': {'nctId': 'NCT00660803', 'briefTitle': 'Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'NIS-OBR-FAS-2007/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Postmenopausal women with hormone-receptor positive, advanced breast cancer who have failed at least one previous endocrine therapy and who have been treated at any one of the participating centres with fulvestrant.', 'interventionNames': ['Drug: Fulvestrant']}], 'interventions': [{'name': 'Fulvestrant', 'type': 'DRUG', 'otherNames': ['Faslodex'], 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Dendrix - Scientific Information Architecture', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Jose Eduardo Neves - Medical Science Director', 'oldOrganization': 'AstraZeneca'}}}}