Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-02-17 @ 6:48 PM
Study NCT ID:
NCT01436604
Status:
TERMINATED
Last Update Posted:
2017-07-28
First Post:
2011-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'lack of recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-27', 'studyFirstSubmitDate': '2011-09-15', 'studyFirstSubmitQcDate': '2011-09-16', 'lastUpdatePostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportions of late enhancement in patients with LV dysfunction as Herceptin ® and in a control group consisting of patients who did not have LV dysfunction after 6 months under the same treatment.', 'timeFrame': '2 years', 'description': 'A cardiac MRI is considered positive if demonstrated a late hyperintense from 15 to 20 minutes after injection of gadolinium chelate, whatever its size, topography subepicardial (intramyocardial) and without vascular systematization.\n\nThe primary endpoint is the proportion of delayed enhancement in the LV dysfunction group and the control group.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients recovering at 6 months in the absence of late enhancement signal in MRI heart after injection of gadolinium and compare the results of biological assays', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cardiac MRI', 'Cancer', 'Breast', 'Herceptin', 'LV dysfunction'], 'conditions': ['Cancer, Breast', 'LV Dysfunction']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to compare the proportions of late enhancement in patients with Left ventricular (LV) dysfunction as Herceptin ® and in a control group consisting of patients who did not have LV dysfunction after 6 months under the same treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women over 18 years\n* Free and informed consent signed\n* Histologically confirmed adenocarcinoma of the breast, metastatic or non-metastatic\n* LVEF\\> 50% angioscintigraphy before the start of treatment with Herceptin ®,\n* Overexpression of HER2 in the invasive component of the primary tumor (3 + 2 + according to ICH or with confirmation of positivity by FISH or CISH)\n* Patient receiving treatment with Herceptin ®,\n* Inclusion in the control group: patients treated with Herceptin ® episode without LV dysfunction,\n* For the inclusion in the Group LV dysfunction: the appearance of a decrease in LVEF during treatment with Herceptin ®, angioscintigraphy identified.\n\nExclusion Criteria:\n\n* Heart disease or serious medical conditions do not allow to administer Herceptin ® (documented history of heart failure, angina requiring treatment, severe dyspnoea at rest or oxygen dependency),\n* History of ischemic heart disease or myocarditis\n* Known allergy to trastuzumab, murine proteins or any of the excipients\n* Patients with an indication against the MRI (claustrophobia, ferromagnetic foreign body, pacemaker or implantable defibrillator, known allergy to gadolinium salts)\n* Renal impairment (creatinine clearance \\<60 ml / min according to the MDRD formula)\n* Arrhythmia atrial fibrillation,\n* Contraindications to the administration of Dotarem ®,\n* Patient unable to give informed consent,\n* Adult Trust,\n* Pregnant or lactating\n* Patient unable to undergo a medical for geographical, social or psychological.'}, 'identificationModule': {'nctId': 'NCT01436604', 'acronym': 'MRTOX', 'briefTitle': 'Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': 'MRTOX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'LV dysfunction group', 'description': 'Cardiac MRI', 'interventionNames': ['Other: Cardiac MRI']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Cardiac MRI', 'interventionNames': ['Other: Cardiac MRI']}], 'interventions': [{'name': 'Cardiac MRI', 'type': 'OTHER', 'description': 'The examinations will be conducted on an MRI with a dedicated antenna heart, by a physician with expertise in cardiac MRI.\n\nAfter establishing a good quality ECG synchronization, the following sequences are carried out successively:\n\n* Sequences locating anatomical\n* T2 black blood (such as ESF)\n* rapid sequence of cine-MRI (such as balanced FFE) vertical and horizontal long axis and short axis of the base to the apex\n* T1-weighted sequence with inversion recovery for the assessment of possible consequences of cell damage.', 'armGroupLabels': ['Control group', 'LV dysfunction group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges-François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Lille', 'country': 'France', 'facility': 'Clinique du Bois', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '54511', 'city': 'Nancy', 'country': 'France', 'facility': 'CHU de NANCY', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'MANRIQUE Alain, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'GIP Cyceron'}, {'name': 'SWITSERS Odile, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre François Baclesse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}