Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-29 @ 8:06 PM
Study NCT ID:
NCT00558168
Status:
COMPLETED
Last Update Posted:
2008-07-28
First Post:
2007-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Study for Anastrozole Pharmacovigilance Evaluation
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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1850}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-25', 'studyFirstSubmitDate': '2007-11-13', 'studyFirstSubmitQcDate': '2007-11-13', 'lastUpdatePostDateStruct': {'date': '2008-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-14', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anastrazole', 'safety', 'early breast cancer'], 'conditions': ['Early Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Collecting information regarding adverse events from patients on treatment with anastrazole with early stage breast cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menopausal Early Invasive Breast Cancer Patients who are under anastrazole treatment, who have normal renal and hepatic functions.\n\nExclusion Criteria:\n\n* Metastatic breast cancer patients, previous hormonal therapy, other malignancies.'}, 'identificationModule': {'nctId': 'NCT00558168', 'acronym': 'E-SAFE', 'briefTitle': 'Electronic Study for Anastrozole Pharmacovigilance Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Electronic Study for Anastrozole Pharmacovigilance Evaluation', 'orgStudyIdInfo': {'id': 'ARI-IPEP-0104'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nejdet Uskent', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kadir Has University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}