Actively Recruiting
Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction
Led by Population Health Research Institute · Updated on 2025-04-06
130
Participants Needed
8
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 defined by either LVEF less than 54% or LVEF 54% or higher with either a fall in LVEF of at least 15% from prior treatment or New York Heart Association class II heart failure symptoms within the past 6 months
You will not qualify if you...
- Current use of both angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) and beta-blocker
- Contraindication to both ACE-I/ARB and beta-blockers
- New York Heart Association class III or IV heart failure
- Left ventricular ejection fraction less than 40%
- Systolic blood pressure below 100 mmHg
- Current or planned pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035903 / 90410000
Actively Recruiting
2
Irmandade Da Santa Casa De Misericórdia De Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
Actively Recruiting
3
Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo, Brazil, 01327-903
Actively Recruiting
4
Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
São Paulo, São Paulo, Brazil, 1317000
Actively Recruiting
5
Juravnski Cancer Centre
Hamitlon, Ontario, Canada
Actively Recruiting
6
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Actively Recruiting
7
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2N2
Actively Recruiting
8
E.Meshalkin National medical research center of the Ministry of Health of the Russian Federation
Novosibirsk, Russia, 630055
Suspended
Research Team
M
Maha Mushtaha, BSc
CONTACT
S
Sumathy Rangarajan, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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