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NCT Number: NCT07630402

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).

Recruiting

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Key information

Conditions

Breast Cancer With Low to Intermediate HER2 Expression

Age range

18 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wilmot Cancer Center

Rochester, New York, 14642, United States

Location status: Recruiting

Location contact

Farhan Bajwa, MD, FACC

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Echocardiogram

Procedure

12-lead echocardiogram

Primary outcomes

  1. Total Number of imaging tests

    Time frame: At the end of therapy, approximately 457 days

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

    Time frame: end of therapy, approximately 457 days

Study contacts

Contact information is provided by the study sponsor or research team.

Kaily LaForce

CONTACT

[email protected]

585-274-2808

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Acronym: POCEB

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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