Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction
Recruiting now · Phase 2
Conditions studied: Breast Cancer, Heart Failure
In brief
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.
Key facts
- Study ID
- NCT04680442
- Run by
- Population Health Research Institute
- People needed
- 130
- Starts
- 2021-07-01
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2025-04-06
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Stage I-III HER-2 positive breast cancer
- Receiving adjuvant or neoadjuvant therapy with trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1)
- 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
You may not qualify if…
- Current use of both angiotensin converting enzyme inhibitor (ACEI) /angiotensin receptor blocker (ARB) and beta-blocker
- Contra-indication to both ACE-I/ARB and beta-blockers
- NYHA class III or IV heart failure
- LVEF <40%
- Systolic blood pressure <100mmHg
- Current or planned pregnancy or breastfeeding
Where it is running
- Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
- Irmandade Da Santa Casa De Misericórdia De Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
- Hospital Alemão Oswaldo Cruz — São Paulo, São Paulo, Brazil (enrolling)
- Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda — São Paulo, São Paulo, Brazil (enrolling)
- Juravnski Cancer Centre — Hamitlon, Ontario, Canada (enrolling)
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (enrolling)
- Toronto General Hospital, University Health Network — Toronto, Ontario, Canada (enrolling)
- E.Meshalkin National medical research center of the Ministry of Health of the Russian Federation — Novosibirsk, Russia
Full record on ClinicalTrials.gov
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