Condition: Breast Cancer · Heart Failure · Sponsor: Population Health Research Institute
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 guidelines versus a more aggressive threshold that allows trastuzumab/pertuzumab/trastuzumab-emtansine to continue at lower levels of LVEF than currently supported by guideline documents.
This description comes directly from the study's public registry record.
Maha Mushtaha, BSc · 9052973479 · maha.mushtaha@phri.ca
Sumathy Rangarajan, MSc · 9052973479 · sumathy.rangarajan@phri.ca
Always discuss trial participation with your own doctor first.
| Hospital de Clínicas de Porto Alegre | Porto Alegre, Rio Grande do Sul, Brazil | Recruiting |
| Irmandade Da Santa Casa De Misericórdia De Porto Alegre | Porto Alegre, Rio Grande do Sul, Brazil | Recruiting |
| Hospital Alemão Oswaldo Cruz | São Paulo, São Paulo, Brazil | Recruiting |
| Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda | São Paulo, São Paulo, Brazil | Recruiting |
| Juravnski Cancer Centre | Hamitlon, Ontario, Canada | Recruiting |
| Ottawa Hospital Research Institute | Ottawa, Ontario, Canada | Recruiting |
| Toronto General Hospital, University Health Network | Toronto, Ontario, Canada | Recruiting |
| E.Meshalkin National medical research center of the Ministry of Health of the Russian Federation | Novosibirsk, Russia | Suspended |
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Source record: clinicaltrials.gov/study/NCT04680442