Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT04429633
Status:
UNKNOWN
Last Update Posted:
2020-06-12
First Post:
2020-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Strain vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D066126', 'term': 'Cardiotoxicity'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': 'C081643', 'term': 'candesartan'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2023-07-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-10', 'studyFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-06-10', 'lastUpdatePostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular ejection fraction (LVEF)', 'timeFrame': 'at months 3,6,9,12,18', 'description': 'Maximum change in LVEF'}], 'secondaryOutcomes': [{'measure': 'Overt chemotherapy induced cardiotoxicity', 'timeFrame': 'any time', 'description': 'LVEF \\< 45%, decline in LVEF by \\>10% to a value to 45-49%, symptomatic congestive heart failure'}, {'measure': 'Changes in cardiac biomarker', 'timeFrame': 'at months 3,6,9,12,18', 'description': 'NT-pro BNP, cardiac troponin'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiotoxicity', 'Breast Cancer', 'Prevention', 'Adjuvant', 'Trastuzumab']}, 'descriptionModule': {'briefSummary': 'Comparing preventive effect of myocardial global longitudinal strain-based cardioprotective stragety (angiotensin receptor blocker prophylaxis) with left ventricular ejection fraction-based strategy in breast cancer patients treated with adjuvant trastuzumab.', 'detailedDescription': 'Despite the left ventricular global longitudinal strain (GLS) enables early prediction of trastuzumab-related cardiomyopathy, its clinical application has been hampered due to the lack of appropriate evaluation and treatment strategies. Therefore, we aimed to evaluate the effect of early intervention strategy (GLS-based cardiotoxicity monitoring and administration of candesartan) by comparing with conventional intervention strategy (left ventricular ejection fraction-based cardiotoxicity monitoring and administration of candesartan) in breast cancer patients who treated with adjuvant trastuzumab.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female aged ≥ 18 years\n* Pathologically confirmed HER2-positive breast cancer\n* Adjuvant treatment plan comprises at least 12 cycles of Trastuzumab\n* Baseline echocardiogram should be performed before starting trastuzumab\n* Cumulative anthracycline dose ≤ 300mg/m2\n* Written informed consent to participate in the study\n\nExclusion Criteria:\n\n* History of hypersensitivity or alllergic reaction to the study medication\n* Metastatic breast cancer\n* Treatment with angiotensin converting enzyme(ACE) inhibitor , Angiotensin receptor blocker (ARB), beta-blocking agents, or diuretics\n* Patients with NCI/CTCAE grade ≥ 2 congestive heart failure, myocardial infarction, symptomatic left ventricular systolic dysfunction, heart's valve disease (≥ moderate), arrhythmias (Grade ≥ 3) \\< 12 months before enrollment\n* Pregnancy or breast feeding\n* Baseline systolic pressure \\< 90mmHg\n* Cumulative anthracycline dose \\> 300mg/m2\n* Serious concurrent illness"}, 'identificationModule': {'nctId': 'NCT04429633', 'briefTitle': 'Strain vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Strain-based vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention Strategy in Patients With Breast Cancer Who Treated With Adjuvant Trastuzumab', 'orgStudyIdInfo': {'id': '2018-11-128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Cardiac intervention', 'description': 'Starting candesartan in patients with left ventricular ejection fraction (LVEF) between 45% and 50% by echocardiogram.', 'interventionNames': ['Drug: Candesartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Early Cardiac intervention', 'description': 'Starting candesartan in patients with decreased myocardial strain below 18% regardless of LVEF by echocardiogram.', 'interventionNames': ['Drug: Candesartan']}], 'interventions': [{'name': 'Candesartan', 'type': 'DRUG', 'description': 'If GLS decreased less than 18% or LVEF decreased to 45-50% during the treatment of adjuvant trastuzumab, start candesartan medication.', 'armGroupLabels': ['Conventional Cardiac intervention', 'Early Cardiac intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yeon Hee Park, MD, Ph.D', 'role': 'CONTACT', 'email': 'yeonh.park@samsung.com', 'phone': '+82-2-3410-3459'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Yeon Hee Park, MD, PhD', 'role': 'CONTACT', 'email': 'yeonh.park@samsung.com', 'phone': '+82-2-3410-3450'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD', 'investigatorFullName': 'Yeon Hee Park', 'investigatorAffiliation': 'Samsung Medical Center'}}}}