[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100414732":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":49,"locations":60,"responsibleParty":173,"collaborators":78,"id":175,"slug":176,"hasResults":177,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":177,"sex":183,"minAge":78,"maxAge":78,"enrollmentInfo":184,"targetDuration":78,"studyType":187,"phases":188,"briefSummary":190,"conditions":191,"keywords":78,"overallStatus":63,"whyStopped":78,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},{"fullName":5,"class":6},"Population Health Research Institute","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","ACTIVE_COMPARATOR","Recommendations for continuing or holding trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) for the control group are guided by an adaptation of the 2008 Canadian recommendations.",[13,14,15],"Drug: Trastuzumab","Drug: Pertuzumab","Drug: Trastuzumab emtansine",{"label":17,"type":18,"description":19,"interventionNames":20},"Intervention Group","EXPERIMENTAL","The intervention group will continue to receive trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) in the setting of asymptomatic decline in LVEF up to an LVEF of 40% as outlined in the criteria listed in Table 3. For reasons of practicality, in the intervention group, the first dose of trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) after randomization can be administered up to 3 weeks late. This will allow time for the participant to be reviewed by a cardiologist and to receive ACE-I\u002Fangiotensin receptor blocker and\u002For beta-blocker, and for dose titration.",[13,14,15],[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Trastuzumab","Trastuzumab is a HER-2 targeting monoclonal antibody that improves overall survival and reduces the risk of recurrent disease in early stage HER-2 positive breast cancer.",[9,17],[28],"Herceptin, Herzuma, Ogivri, Trazimera, Kanjinti",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Pertuzumab","Pertuzumab (also called 2C4, trade name Perjeta) is a monoclonal antibody used in combination with trastuzumab and docetaxel for the treatment of metastatic HER2-positive breast cancer; it also used in the same combination as a neoadjuvant in early HER2-positive breast cancer",[9,17],[34],"Perjeta",{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Trastuzumab emtansine","Ado-trastuzumab emtansine is approved to treat: Breast cancer that is HER2 positive and has already been treated with a taxane and trastuzumab.",[9,17],[40],"Kadcyla,",[42,46],{"name":43,"affiliation":44,"role":45},"Darryl Leong, PhD. MBBSm","McMaster University","PRINCIPAL_INVESTIGATOR",{"name":47,"affiliation":48,"role":45},"Som Mukherjee, MD MSc FRCPC","Hamilton Health Sciences Corporation",[50,56],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},"Maha Mushtaha, BSc","CONTACT","9052973479","41084","maha.mushtaha@phri.ca",{"name":57,"role":52,"phone":53,"phoneExt":58,"email":59},"Sumathy Rangarajan, MSc","40464","sumathy.rangarajan@phri.ca",[61,85,96,109,119,132,146,161],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Hospital de Clínicas de Porto Alegre","RECRUITING","Porto Alegre","Rio Grande do Sul","90035903 \u002F 90410000","Brazil","BR",{"type":70,"coordinates":71},"Point",[72,73],-51.23019,-30.03283,{"lat":73,"lon":72},[76,80,83],{"name":77,"role":52,"phone":78,"phoneExt":78,"email":79},"Nathalia Santos",null,"natsantos@haoc.com.br",{"name":81,"role":52,"phone":78,"phoneExt":78,"email":82},"Rafael Zimmer","rzimmer@hcpa.edu.br",{"name":84,"role":45,"phone":78,"phoneExt":78,"email":78},"Felipe Homem Valle",{"facility":86,"status":63,"city":64,"state":65,"zip":87,"country":67,"countryCode":68,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"Irmandade Da Santa Casa De Misericórdia De Porto Alegre","90050-170",{"type":70,"coordinates":89},[72,73],{"lat":73,"lon":72},[92,94],{"name":77,"role":52,"phone":78,"phoneExt":78,"email":93},"natsantos@haoc.com",{"name":95,"role":45,"phone":78,"phoneExt":78,"email":78},"Katsuki Tiscoski",{"facility":97,"status":63,"city":98,"state":98,"zip":99,"country":67,"countryCode":68,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Hospital Alemão Oswaldo Cruz","São Paulo","01327-903",{"type":70,"coordinates":101},[102,103],-46.63611,-23.5475,{"lat":103,"lon":102},[106,107],{"name":77,"role":52,"phone":78,"phoneExt":78,"email":79},{"name":108,"role":45,"phone":78,"phoneExt":78,"email":78},"Pedro Exman",{"facility":110,"status":63,"city":98,"state":98,"zip":111,"country":67,"countryCode":68,"cosmosGeoPoint":112,"geoPoint":114,"contacts":115},"Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda","1317000",{"type":70,"coordinates":113},[102,103],{"lat":103,"lon":102},[116,117],{"name":77,"role":52,"phone":78,"phoneExt":78,"email":79},{"name":118,"role":45,"phone":78,"phoneExt":78,"email":78},"André Mattar",{"facility":120,"status":63,"city":121,"state":122,"zip":78,"country":123,"countryCode":124,"cosmosGeoPoint":78,"geoPoint":78,"contacts":125},"Juravnski Cancer Centre","Hamitlon","Ontario","Canada","CA",[126,131],{"name":127,"role":52,"phone":128,"phoneExt":129,"email":130},"Som Mukherjee","905-387-9711","63123","mukherjee@HHSC.CA",{"name":127,"role":45,"phone":78,"phoneExt":78,"email":78},{"facility":133,"status":63,"city":134,"state":122,"zip":78,"country":123,"countryCode":124,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Ottawa Hospital Research Institute","Ottawa",{"type":70,"coordinates":136},[137,138],-75.69812,45.41117,{"lat":138,"lon":137},[141,144],{"name":142,"role":52,"phone":78,"phoneExt":78,"email":143},"Kelsey Ross","kelross@ohri.ca",{"name":145,"role":45,"phone":78,"phoneExt":78,"email":78},"Marie-France Savard",{"facility":147,"status":63,"city":148,"state":122,"zip":149,"country":123,"countryCode":124,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Toronto General Hospital, University Health Network","Toronto","M5G 2N2",{"type":70,"coordinates":151},[152,153],-79.39864,43.70643,{"lat":153,"lon":152},[156,159],{"name":157,"role":52,"phone":78,"phoneExt":78,"email":158},"Tiffanie Kei","tiffanie.kei@uhn.ca",{"name":160,"role":45,"phone":78,"phoneExt":78,"email":78},"Dinesh Thavendiranathan",{"facility":162,"status":163,"city":164,"state":78,"zip":165,"country":166,"countryCode":167,"cosmosGeoPoint":168,"geoPoint":172,"contacts":78},"E.Meshalkin National medical research center of the Ministry of Health of the Russian Federation","SUSPENDED","Novosibirsk","630055","Russia","RU",{"type":70,"coordinates":169},[170,171],82.93175,55.02259,{"lat":171,"lon":170},{"type":174,"investigatorFullName":78,"investigatorTitle":78,"investigatorAffiliation":78,"oldNameTitle":78,"oldOrganization":78},"SPONSOR","100414732","phase-2-safety-of-continuing-her-2-directed-therapy-in-overt-left-ventricular-dysfunction-100414732",false,"NCT04680442","Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction","Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction: A Randomized, Controlled Trial","SCHOLAR-2","Inclusion Criteria:\n\n1. Stage I-III HER-2 positive breast cancer\n2. Receiving adjuvant or neoadjuvant therapy with trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1)\n3. Evidence of left ventricular dysfunction, as defined by at least one of:\n\n   a) LVEF \\\u003C 54% or b) LVEF ≥54% and either i) fall in LVEF of ≥15% from prior to trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) exposure, or ii) New York Heart Association (NYHA) class II heart failure symptoms within the past 6 months\n\nExclusion Criteria:\n\n1. Current use of both angiotensin converting enzyme inhibitor (ACEI) \u002Fangiotensin receptor blocker (ARB) and beta-blocker\n2. Contra-indication to both ACE-I\u002FARB and beta-blockers\n3. NYHA class III or IV heart failure\n4. LVEF \\\u003C40%\n5. Systolic blood pressure \\\u003C100mmHg\n6. Current or planned pregnancy or breastfeeding","ALL",{"count":185,"type":186},130,"ESTIMATED","INTERVENTIONAL",[189],"PHASE2","Trastuzumab is an important treatment for HER 2 positive breast cancer. But trastuzumab can cause injury to the heart, and this is one of the main reasons it cannot be administered as planned. Heart injury can often be successfully treated using cardiac medications. The objectives of SCHOLAR-2 are to evaluate whether is it safe and effective to continue trastuzumab, pertuzumab or trastuzumab-emtansine (T-DM1) in patients with early stage HER-2 positive breast cancer despite mild, minimally symptomatic or asymptomatic systolic left ventricular dysfunction as compared with a guideline-driven approach of withholding or discontinuing trastuzumab, pertuzumab or trastuzumab-emtansine (T-DM1).\n\nIn SCHOLAR-2, we will compare two thresholds of withholding or discontinuing trastuzumab\u002Fpertuzumab\u002Ftrastuzumab-emtansine: a threshold that is currently advocated for by existing treatment practice guidelines versus a more aggressive threshold that allows trastuzumab\u002Fpertuzumab\u002Ftrastuzumab-emtansine to continue at lower levels of LVEF than currently supported by guideline documents.",[192,193],"Breast Cancer","Heart Failure","2025-04-03",{"date":196,"type":197},"2025-04-06","ACTUAL",{"date":199,"type":197},"2021-07-01",{"date":201,"type":186},"2026-06-30",{"name":5,"class":6},8]