Tests continuing HER-2 breast cancer drugs despite mild heart weakness
Tests whether continuing HER-2 breast cancer drugs is safe with mild heart weakness.
Plain-language title generated from the registry record
Registry title: Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction
Key facts
- Where
- Porto Alegre and São Paulo, BrazilSee the 4 sites
- Phase
- Phase 2
Where in Brazil
- Hospital de Clinicas de Porto AlegrePorto Alegre, BrazilTaking people
- Irmandade Da Santa Casa de Misericordia de Porto AlegrePorto Alegre, BrazilTaking people
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria LtdaSão Paulo, BrazilTaking people
- Hospital Alemão Oswaldo CruzSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Population Health Research Institute
- Trial code
- NCT04680442
- Record updated
- 6 April 2025
- Original description
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).Read full original descriptionShow less
Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction: A Randomized, Controlled Trial
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.
Inclusion: 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:; 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: Current use of both angiotensin converting enzyme inhibitor (ACEI) /angiotensin receptor blocker (ARB) and beta-blocker; NYHA class III or IV heart failure; LVEF <40%; Contra-indication to both ACE-I/ARB and beta-blockers; Systolic blood pressure <100mmHg; Current or planned pregnancy or breastfeeding.