Clinical trial Recruiting at 1 site Interventional Ages 18 to 79 Women only

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.

More Breast Cancer With Low to Intermediate HER2 Expression trials

Quick facts

Study typeInterventional
Ages18 Years to 79 Years
SexWomen only
Enrollment20 (estimated)
SponsorUniversity of Rochester
Academic / other
Locations1 site (Rochester, New York)
StatusRecruiting
StartedNovember 17, 2025
Main results expectedJune 30, 2031
Study endsJune 30, 2031
Registry record updatedJune 5, 2026
Trial IDNCT07630402 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.