Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT00562458
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2007-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Study to Evaluate Arimidex in Postmenopausal Women With Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077384', 'term': 'Anastrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'lastUpdateSubmitDate': '2013-02-04', 'studyFirstSubmitDate': '2007-11-21', 'studyFirstSubmitQcDate': '2007-11-21', 'lastUpdatePostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-22', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced breast cancer', 'Advanced breast cancer in postmenopausal women'], 'conditions': ['Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate Arimidex 6 month therapy as an adjuvant treatment in postmenopausal patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Postmenopausal patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients to be included in the program are that ones according to the indications specified in the Romanian anastrozole (Arimidex) approved SmPC (attached to the protocol)and who are already treated with anastrozole for at least 1 month before inclusion in this program/non-interventional study.\n\nExclusion Criteria:\n\n* Patients not to be included in the programme: patients who have a known hypersensitivity to anastrozole (Arimidex®) or any of its excipients.'}, 'identificationModule': {'nctId': 'NCT00562458', 'briefTitle': 'Non-interventional Study to Evaluate Arimidex in Postmenopausal Women With Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'ARIMIDEX Study ( Non-interventional Study to Evaluate Arimidex in Adjuvant Therapy in Partial or Complete Response or Stabilized Disease After First Line Chemotherapy in Postmenopausal Women With Advanced Breast Cancer)', 'orgStudyIdInfo': {'id': 'NIS-ARO-HCH-2006/1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'anastrozole', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}