Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT02772367
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2016-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D066126', 'term': 'Cardiotoxicity'}], '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'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'skin tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2016-05-11', 'studyFirstSubmitQcDate': '2016-05-11', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'derive iPSs from skin fibroblasts', 'timeFrame': '1 day', 'description': 'described by Yamanaka et al with modification using the Millipore STEMCCA excisable polycystronic lentivirus reprogramming kit.2'}]}, 'conditionsModule': {'keywords': ['cardiotoxicity', '16-025'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether cells from a biopsy taken from the patient skin can be transformed into cardiomyocytes the changes in cardiomyocyte (heart muscle cells) when grown in a special culture medium outside of the body. The structure and function of these cells will then be studied to determine why some patients with breast cancer who are treated with chemotherapy including anthracycline (e.g. Doxorubicin) and anti-HER2 therapy (e.g. Herceptin) develop decreased heart function.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering Cancer Center (MSKCC).", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Age greater than 18 years\n* Willing to participate in protocol procedures with signed informed consent\n* Assessment of LVEE via echocardiogram, cardiac MRI, or MUGA\n\nSubjects in the cardiotoxicity group (TOX) must meet the following criteria:\n\n* History of HER2 positive breast cancer (stage I-IV)\n* Prior/current treatment with anthracycline based chemotherapy followed by anti-HER2 directed therapy or anti-HER2 directed therapy alone\n* Assessment of LVEF at baseline prior to initiation of anthracycline or anti-HER2 therapy and during anti-HER2 therapy via echocardiogram, cardiac MRI, or MUGA\n* Prior confirmed diagnosis of cardiotoxicity associated with anti-HER2 based therapy, defined as a decrease in LVEF \\> 10% from baseline to \\< 53% with symptoms of heart failure (NYHA class II-IV).\n\nSubjects in the no cardiotoxicity group (NO-TOX) must meet the following criteria:\n\n* History of HER2 positive breast cancer (stage I-IV)\n* Completion of planned anthracycline and anti-HER2 therapy, or anti-HER2 therapy alone\n* No symptoms of heart failure (NYHA class II-IV) during and at the end of anthracycline and anti-HER2 therapy\n* Assessment of LVEF at baseline prior to innitiation of anthracycline or anti-HER2 therapy and during anti-HER2 therapy via echocardiogram, cardiac MRI, or MUGA\n* Normal LVEF \\>53% at each assessment during and at the end of trastuzumab therapy.\n* Maximum absolute decrease in LVEF \\<5% from baseline during and at the end of trastuzumab therapy.\n* LVEF assessment performed at baseline and at least two time points during trastuzumab therapy.\n\nExclusion Criteria:\n\n* Unwilling or unable to give skin biopsies\n* Contraindications to punch biopsy including but not limited to bleeding diathesis, as determined by the investigator.\n* Known pre-existing CV disease prior to initiation of breast cancer therapy as determined by the investigator, including\n\n * Obstructive coronary artery disease (stenosis \\>70%)\n * Arrhythmia - paroxysmal or persistent atrial arrhythmias, sustained ventricular tachycardia (\\>30 seconds), ventricular fibrillation, or cardiac arrest\n * Cardiomyopathy (EF \\<53%)\n * Heart failure (NYHA class II-IV)\n * Valvular heart disease with equal to or greater than moderate stenosis or regurgitation'}, 'identificationModule': {'nctId': 'NCT02772367', 'briefTitle': 'Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Generation of Induced Pluripotent Stem Cell Derived Cardiomyocytes From Patients Exposed to Trastuzumab Therapy for Breast Cancer', 'orgStudyIdInfo': {'id': '16-025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Cancer Patients', 'description': 'In study participants undergoing breast reconstruction surgery prior to breast radiation therapy, we will obtain skin tissue at the time of reconstruction surgery from the surgical specimen.', 'interventionNames': ['Procedure: skin punch biopsy']}], 'interventions': [{'name': 'skin punch biopsy', 'type': 'PROCEDURE', 'armGroupLabels': ['Breast Cancer Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angel Chan, MD, PhD', 'role': 'CONTACT', 'phone': '212-639-7217'}], 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Angel Chan, MD, PhD', 'role': 'CONTACT', 'email': 'chana5@mskcc.org', 'phone': '212-639-7217'}, {'name': 'Richard Steingart, MD', 'role': 'CONTACT', 'phone': '212-639-8488'}], 'overallOfficials': [{'name': 'Angel Chan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}