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JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year

RecruitingNAAges 18 Years - 79 YearsAllWomen's College Hospital
NCT06930521 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study focuses on male and female patients being treated for breast cancer that is positive for the HER2 receptor which requires special treatments targeting that receptor. The problem is that these treatments, while effective for the cancer, can sometimes harm the heart. Because of this, patients have to undergo heart tests every three months during treatment, even if they have no history of heart disease or feel fine. The guidelines for these regular heart tests were established decades ago when these treatments were first introduced, but research shows that most of these tests don't actually change the treatment plan. This suggests that many patients are going through unnecessary tests, which can cause stress, delay treatments, and increase healthcare costs. To address this, the researchers propose a new study with 300 patients with HER2 positive breast cancer to test a more per

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Stage 1-3 breast cancer (BC). 2. Age 18-79 years. 3. HER-2 positive BC with planned HER2 targeted therapy (HER2TT) for curative intent. Exclusion Criteria: 1. Distant metastases detected clinically, radiographically, or histologically 2. Baseline echocardiogram images of insufficient quality for a quantitative assessment of left ventricular ejection fraction (LVEF) 3. Pre-existing cardiovascular disease, defined as: 1. Prior myocardial infarction (even if LVEF has normalized) 2. Prior heart failure (HF, including patients with preserved ejection fraction and normalized LVEF) 3. Baseline LVEF \<55% 4. Atrial fibrillation 5. Greater than moderate valvular disease (i.e., severe, or moderate-severe) 4. Cumulative anthracycline exposure ≥250mg/m2 before starting HER2TT 5. New York Heart Association Functional Class II, III or IV, or Eastern Cooperative Oncology Group score \>2\* 6. Symptoms potentially due to serious cardiac disease as per investigator's judgement\* \*Exclusion criterion adopted as they make clinical assessment less reliable to detect emergent HF.
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What it tests

  • Intervention - Low Risk Group OR Intermediate Risk Group
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Where

1 site
Toronto General Hospital
Toronto, Canada
🤝 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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