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.
Key facts
- Who runs it
- Population Health Research Institute
- Where
- Hamitlon, Ottawa, and Toronto, CanadaSee the 3 sitesAlso in 2 other countries, 5 sites
- Trial code
- Registry title
- Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 130 people, planned
- Started
- 1 Jul 2021
- Planned end
- 30 Jun 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Trastuzumab
- Pertuzumab
- Trastuzumab emtansine
- Record updated
- 6 April 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with early stage HER-2 positive breast cancer who are getting trastuzumab, pertuzumab or T-DM1 and whose heart pumps less well than normal.
- Sex
- All sexes can join.
- Disease stage
- Stage I-III HER-2 positive breast cancer, with signs of left ventricular dysfunction: LVEF < 54%, or LVEF ≥54% with a fall of ≥15% or NYHA class II heart failure symptoms in the past 6 months.
- Earlier treatment
- Must be getting trastuzumab, pertuzumab or trastuzumab-emtansine (T-DM1) before or after surgery.
- Biomarker or test result
- HER-2 positive breast cancer; heart pumping measured as LVEF.
Main reasons for not taking part
- Already taking both an ACE inhibitor or ARB and a beta-blocker
- Cannot take both ACE-I/ARB and beta-blockers
- NYHA class III or IV heart failure
- LVEF <40%
- Systolic blood pressure <100mmHg
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Canada
Also in 2 other countries, 5 sites
- Juravnski Cancer CentreHamitlon, CanadaContact: Som MukherjeeTaking people
- Ottawa Hospital Research InstituteOttawa, CanadaContact: Kelsey RossTaking people
- Toronto General Hospital, University Health NetworkToronto, CanadaContact: Tiffanie KeiTaking people
About the trial
What the trial wants to find out
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
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.
The 2 groups in the trial
- Control GroupExisting treatment, for comparison
Recommendations for continuing or holding trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) for the control group are guided by an adaptation of the 2008 Canadian recommendations.
Treatment: Trastuzumab, Pertuzumab, and Trastuzumab emtansine
- Intervention GroupTreatment being tested
The intervention group will continue to receive trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) in the setting of asymptomatic decline in LVEF up to an LVEF of 40% as outlined in the criteria listed in Table 3. For reasons of practicality, in the intervention group, the first dose of trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) after randomization can be administered up to 3 weeks late. This will allow time for the participant to be reviewed by a cardiologist and to receive ACE-I/angiotensin receptor blocker and/or beta-blocker, and for dose titration.
Treatment: Trastuzumab, Pertuzumab, and Trastuzumab emtansine
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction: A Randomized, Controlled Trial
- Plain-language title
- Tests continuing HER-2 breast cancer drugs despite mild heart weaknessGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 6 April 2025