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Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction

RecruitingPhase 2Ages any - anyAllPopulation Health Research Institute
NCT04680442 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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). In SCHOLAR-2, we will compare two thresholds of withholding or discontinuing trastuzumab/pertuzumab/trastuzumab-emtansine: a threshold that is currently advocated for by existing treatment practice guide

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Stage I-III HER-2 positive breast cancer 2. Receiving adjuvant or neoadjuvant therapy with trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) 3. Evidence of left ventricular dysfunction, as defined by at least one of: a) LVEF \< 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 Exclusion Criteria: 1. Current use of both angiotensin converting enzyme inhibitor (ACEI) /angiotensin receptor blocker (ARB) and beta-blocker 2. Contra-indication to both ACE-I/ARB and beta-blockers 3. NYHA class III or IV heart failure 4. LVEF \<40% 5. Systolic blood pressure \<100mmHg 6. Current or planned pregnancy or breastfeeding
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What it tests

  • Trastuzumab
  • Pertuzumab
  • Trastuzumab emtansine
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Where

8 sites
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Irmandade Da Santa Casa De Misericórdia De Porto Alegre
Porto Alegre, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil
Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
São Paulo, Brazil
Juravnski Cancer Centre
Hamitlon, Canada
Ottawa Hospital Research Institute
Ottawa, Canada
Toronto General Hospital, University Health Network
Toronto, Canada
E.Meshalkin National medical research center of the Ministry of Health of the Russian Federation
Novosibirsk, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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