Optimization of Cardiac Imaging in Women With Early-Stage Breast Cancer

NCT07630402 | Recruiting

• 1 other identifier: STUDY00010778
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a personalized, risk-stratified surveillance strategy can safely reduce unnecessary cardiac imaging while preserving early detection of treatment-related cardiotoxicity in women with breast cancer (BC) receiving HER2-targeted therapy (HER2-TT).

Conditions

Breast Cancer With Low to Intermediate HER2 Expression

Outcome Measures

Primary Outcomes (2)

• Total Number of imaging tests

  At the end of therapy, approximately 457 days

• Time to completion of HER 2 (human epidermal growth factor receptor 2) target therapy in days

  end of therapy, approximately 457 days

Study Arms (2)

Standard-of-care Group

ACTIVE COMPARATOR

Participants in this group will receive echocardiogram imaging before cycles 1, 5, 9, and 13 of trastuzumab (or every 3 months) and another echocardiogram after completion of trastuzumab (within 100 days after completion of HER2-TT).

Procedure: Echocardiogram

Judicious-imaging Group

EXPERIMENTAL

The Judicious Imaging Group will get split into two separate subgroups, intermediate-risk or low-risk, depending on their risk of heart failure, which will determine how many echocardiograms they will receive. The low-risk subgroup will get an echocardiogram once every 6 months (before cycles 1 and 9 and after the completion of trastuzumab). The intermediate-risk subgroup will get an echocardiogram approximately once every 4 months (before cycles 1, 6, and 12 and after completion of trastuzumab).

Procedure: Echocardiogram

Interventions

Echocardiogram PROCEDURE

12-lead echocardiogram

Judicious-imaging Group; Standard-of-care Group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Wilmot Cancer Center

Rochester, New York, 14642, United States

RECRUITING

Central Study Contacts

Kaily LaForce

CONTACT

585-274-2808; kaily_laforce@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: November 17, 2025
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)