Recruiting

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

ClinicalTrials.gov IDNCT04680442

PhasePHASE2

Enrollment130

SponsorPopulation Health Research Institute

AgeNo minimum reported

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer, Heart Failure

About this study

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.

Interventions

Drug: Trastuzumab — Trastuzumab is a HER-2 targeting monoclonal antibody that improves overall survival and reduces the risk of recurrent disease in early stage HER-2 positive breast cancer.
Drug: Pertuzumab — Pertuzumab (also called 2C4, trade name Perjeta) is a monoclonal antibody used in combination with trastuzumab and docetaxel for the treatment of metastatic HER2-positive breast cancer; it also used in the same combination as a neoadjuvant in early HER2-positive breast cancer
Drug: Trastuzumab emtansine — Ado-trastuzumab emtansine is approved to treat: Breast cancer that is HER2 positive and has already been treated with a taxane and trastuzumab.

Primary outcomes

primary efficacy outcome (one year)
co-primary safety outcomes (one year)

Eligibility information

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

Study locations

Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul 90035903 / 90410000 Brazil
Irmandade Da Santa Casa De Misericórdia De Porto Alegre, Porto Alegre, Rio Grande do Sul 90050-170 Brazil
Hospital Alemão Oswaldo Cruz, São Paulo, São Paulo 01327-903 Brazil
Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda, São Paulo, São Paulo 1317000 Brazil
Juravnski Cancer Centre, Hamitlon, Ontario Canada
Ottawa Hospital Research Institute, Ottawa, Ontario Canada
Toronto General Hospital, University Health Network, Toronto, Ontario M5G 2N2 Canada
E.Meshalkin National medical research center of the Ministry of Health of the Russian Federation, Novosibirsk, 630055 Russia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.