[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02772367":3,"trial-entities:NCT02772367":97,"trial-summary:NCT02772367":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":15,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":32,"secondary_outcomes":37,"sex":38,"minimum_age":39,"maximum_age":15,"healthy_volunteers":40,"eligibility_criteria":41,"std_ages":67,"locations":70,"central_contacts":84,"overall_officials":90,"references":93,"see_also_links":94},"NCT02772367","16-025","Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients","Generation of Induced Pluripotent Stem Cell Derived Cardiomyocytes From Patients Exposed to Trastuzumab Therapy for Breast Cancer","RECRUITING","2027-05","2026-06","2026-06-03","2016-05-11","Memorial Sloan Kettering Cancer Center","OTHER",null,"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.",[18],"Breast Cancer",[20,5],"cardiotoxicity","OBSERVATIONAL",[],{"count":24,"type":25},120,"ESTIMATED",[27],{"type":28,"name":29,"armGroupLabels":30},"PROCEDURE","skin punch biopsy",[31],"Breast Cancer Patients",[33],{"measure":34,"description":35,"timeFrame":36},"derive iPSs from skin fibroblasts","described by Yamanaka et al with modification using the Millipore STEMCCA excisable polycystronic lentivirus reprogramming kit.2","1 day",[],"FEMALE","18 Years",false,{"inclusion":42,"exclusion":57,"raw_text":66},[43,44,45,46,47,48,49,50,47,51,52,53,54,55,56],"Female","Age greater than 18 years","Willing to participate in protocol procedures with signed informed consent","Assessment of LVEE via echocardiogram, cardiac MRI, or MUGA","History of HER2 positive breast cancer (stage I-IV)","Prior\u002Fcurrent treatment with anthracycline based chemotherapy followed by anti-HER2 directed therapy or anti-HER2 directed therapy alone","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","Prior confirmed diagnosis of cardiotoxicity associated with anti-HER2 based therapy, defined as a decrease in LVEF \\> 10% from baseline to \\\u003C 53% with symptoms of heart failure (NYHA class II-IV).","Completion of planned anthracycline and anti-HER2 therapy, or anti-HER2 therapy alone","No symptoms of heart failure (NYHA class II-IV) during and at the end of anthracycline and anti-HER2 therapy","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","Normal LVEF \\>53% at each assessment during and at the end of trastuzumab therapy.","Maximum absolute decrease in LVEF \\\u003C5% from baseline during and at the end of trastuzumab therapy.","LVEF assessment performed at baseline and at least two time points during trastuzumab therapy.",[58,59,60,61,62,63,64,65],"Unwilling or unable to give skin biopsies","Contraindications to punch biopsy including but not limited to bleeding diathesis, as determined by the investigator.","Known pre-existing CV disease prior to initiation of breast cancer therapy as determined by the investigator, including","Obstructive coronary artery disease (stenosis \\>70%)","Arrhythmia - paroxysmal or persistent atrial arrhythmias, sustained ventricular tachycardia (\\>30 seconds), ventricular fibrillation, or cardiac arrest","Cardiomyopathy (EF \\\u003C53%)","Heart failure (NYHA class II-IV)","Valvular heart disease with equal to or greater than moderate stenosis or regurgitation","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\u002Fcurrent 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 \\\u003C 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 \\\u003C5% 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 \\\u003C53%)\n  * Heart failure (NYHA class II-IV)\n  * Valvular heart disease with equal to or greater than moderate stenosis or regurgitation",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":72,"status":8,"city":73,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":81},"Memorial Sloan-Kettering Cancer Center","New York","10065","United States",[77],{"name":78,"role":79,"phone":80},"Angel Chan, MD, PhD","CONTACT","212-639-7217",{"lat":82,"lon":83},40.71427,-74.00597,[85,87],{"name":78,"role":79,"phone":80,"email":86},"chana5@mskcc.org",{"name":88,"role":79,"phone":89},"Richard Steingart, MD","212-639-8488",[91],{"name":78,"affiliation":13,"role":92},"PRINCIPAL_INVESTIGATOR",[],[95],{"label":13,"url":96},"https:\u002F\u002Fwww.mskcc.org\u002F",{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Breast Carcinoma",[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an observational study with a planned enrollment of 120 women. It is not a treatment study, but rather aims to understand how certain breast cancer treatments affect the heart.","completed","Studying Heart Health in Breast Cancer Patients","This observational study aims to understand why some breast cancer patients treated with chemotherapy, specifically anthracycline-based drugs like Doxorubicin and anti-HER2 therapy like Herceptin, develop heart problems. Researchers will take a small skin sample (skin punch biopsy) from participants. They will then turn these skin cells into heart muscle cells (cardiomyocytes) in a lab. By studying these lab-grown heart cells, they hope to learn more about how these treatments affect heart function. The study is looking for 120 women over 18 years old who have HER2-positive breast cancer and have received anthracycline-based chemotherapy. The main goal is to successfully create these heart cells from skin cells within one day. The current recruitment status is unclear.","The primary endpoint, deriving iPSs from skin fibroblasts, is measured at 1 day. Further follow-up information is not specified.",115,"You would undergo a skin punch biopsy. Your heart function would be assessed via echocardiogram, cardiac MRI, or MUGA.","Not stated in the trial record.",[29],"v2"]