NCT04680442 Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction
| NCT ID | NCT04680442 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Population Health Research Institute |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2021-07-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 130 participants in total. It began in 2021-07-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Darryl Leong, PhD. MBBSm
PRINCIPAL INVESTIGATOR
McMaster University
Frequently Asked Questions
Who can join the NCT04680442 clinical trial?
This trial is open to participants of all sexes, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04680442 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04680442 currently recruiting?
Yes, NCT04680442 is actively recruiting participants. Contact the research team at maha.mushtaha@phri.ca for enrollment information.
Where is the NCT04680442 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil, Porto Alegre, Brazil, São Paulo, Brazil, São Paulo, Brazil and 4 additional locations.
Who is sponsoring the NCT04680442 clinical trial?
NCT04680442 is sponsored by Population Health Research Institute. The principal investigator is Darryl Leong, PhD. MBBSm at McMaster University. The trial plans to enroll 130 participants.
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