Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT00885612
Status:
COMPLETED
Last Update Posted:
2010-06-29
First Post:
2009-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
10 Year Coronary Heart Disease (CHD) Risk Evaluation and Its Treatment Pattern Analysis in Postmenopausal Early Breast Cancer (EBC) Patients Taking Aromatase Inhibitors (AI)
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-28', 'studyFirstSubmitDate': '2009-04-21', 'studyFirstSubmitQcDate': '2009-04-21', 'lastUpdatePostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study is to define 10-year CHD risk according to Framingham risk score in postmenopausal early breast cancer patients who are taking aromatase inhibitors as an adjuvant treatment.', 'timeFrame': '1 visit'}], 'secondaryOutcomes': [{'measure': 'To describe 10-year CHD risk comparing to the historical data of 10-year cancer-specific mortality in breast cancer', 'timeFrame': '1 Visit'}, {'measure': 'To analyse CHD management patterns according to defined 10-year CHD risk categories', 'timeFrame': '1 Visit'}, {'measure': 'To describe correlation between concommitant medication(Anthracycline, Trasuzumab) and CHD risk', 'timeFrame': '1 Visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CHD-Risk', 'Breast Cancer', 'Aromatase Inhibitors', 'postmenopausal early breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '10-year CHD risk evaluation and its treatment pattern analysis in postmenopausal early breast cancer patients taking aromatase inhibitors.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Postmenopausal patients with early breast cancer, who are taking aromatase inhibitors no longer than 6 months as an adjuvant treatment after surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Early Breast Cancer patients\n* Postmenopausal Status\n* patients taking Aromatase Inhibitor as adjuvant treatment no longer than 6 months\n\nExclusion Criteria:\n\n* Advanced Breast Cancer patients(stage iii, iv)\n* Patients who are hard to be analysed by limitation of chart record according to investigators discretion\n* patients who already have been registered in this study'}, 'identificationModule': {'nctId': 'NCT00885612', 'briefTitle': '10 Year Coronary Heart Disease (CHD) Risk Evaluation and Its Treatment Pattern Analysis in Postmenopausal Early Breast Cancer (EBC) Patients Taking Aromatase Inhibitors (AI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '10-year CHD Risk Evaluation and Its Treatment Pattern Analysis in Postmenopausal Early Breast Cancer Patients Taking Aromatase Inhibitors', 'orgStudyIdInfo': {'id': 'NIS-OKR-DUM-2009/1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Cheonan', 'state': 'Chungcheongnam-do', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Chuncheon', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'city': 'Pohang', 'state': 'Gyeongsangbuk-do', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 36.02917, 'lon': 129.36481}}, {'city': 'Masan-si', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Anyang', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gangneung', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.75266, 'lon': 128.87239}}, {'city': 'GuangJu', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Inchon', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.55479, 'lon': 126.6251}}, {'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Junam', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.42306, 'lon': 129.15398}}, {'city': 'Koyang', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Kyunggi', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul(Kangbuk)', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul(Kangdong)', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul(Kangnam)', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul(Yeouido)', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'JoonWoo Bahn, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MC MD', 'oldOrganization': 'AstraZeneca'}}}}