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Clinical Trials/NCT07630402
NCT07630402RecruitingNot Applicable

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

University of Rochester1 site in 1 country20 target enrollmentStarted: November 17, 2025Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 79 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Farhan Bajwa

Assistant Professor

University of Rochester

Study Sites (1)

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