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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer With Low to Intermediate HER2 Expression
• Intervention / Treatment: Procedure: Echocardiogram

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kaily LaForce; Phone Number: 585-274-2808; Email: kaily_laforce@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • Wilmot Cancer Center
      • Principal Investigator: Farhan Bajwa, MD, FACC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard-of-care Group; 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; 12-lead echocardiogram
Experimental: Judicious-imaging Group; 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; 12-lead echocardiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2025
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00010778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No