Personalized cardiac imaging approach for women with early breast cancer on HER2 therapy
Official title: Pilot Study for Optimization of Cardiac Imaging in Women With Early-Stage Breast Cancer
Run by University of Rochester · NCT07630402 · Data updated 2026-11-12
This study tests a personalized, risk-based plan to reduce unnecessary heart imaging while still catching heart problems early in women with HER2-positive breast cancer receiving HER2-targeted therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 79 Years |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Status | Recruiting |
| Started | November 17, 2025 |
| Main results expected | June 30, 2031 |
| Study ends | June 30, 2031 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT07630402 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women 18-79 with HER2-positive breast cancer scheduled for about 12 months of HER2-targeted therapy and normal baseline LVEF seeking personalized imaging.
✕Probably not a fit
Patients with higher baseline risk who still require frequent imaging or those who develop cardiotoxicity early may not benefit from reduced imaging frequency.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study examines whether a risk-stratified imaging strategy can safely reduce routine echocardiograms without compromising early detection of cardiotoxicity during about one year of HER2-targeted therapy. Eligible participants are women aged 18-79 with HER2-positive breast cancer and preserved baseline heart function, at Rochester's Wilmot Cancer Center. The study uses echocardiography as the primary imaging modality, guided by individual cardiovascular risk factors. Exclusion criteria include prior heart disease, significant rhythm or valve issues, high cumulative anthracycline exposure, and pregnancy. The lead sponsor is the University of Rochester, with enrollment at a single site.
Why it matters
Potential benefit: If successful, patients may experience fewer unnecessary heart scans without missing early signs of cardiotoxicity.
How similar studies have gone: Prior research in cardio-oncology supports targeted imaging strategies, but this exact risk-stratified approach is being evaluated in this specific setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female sex, age 18-79 years. * Histologically confirmed HER2-positive BC scheduled for ≈12 months of adjuvant HER2-TT * Baseline LVEF ≥ 55 % by 2-D echocardiography. * Ability to provide informed consent. Exclusion Criteria: * Prior HF, myocardial infarction, or cardiomyopathy. * Atrial fibrillation or significant valvular heart disease. * Cumulative anthracycline dose ≥ 250 mg/m². * Pregnancy or lactation. * Inability to comply with study procedures.
Where it's running
-
Wilmot Cancer Center
Rochester, New York, United States Recruiting
Study contacts
- Study coordinator: Kaily LaForce
- Email: kaily_laforce@urmc.rochester.edu
- Phone: 585-274-2808
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.