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

University of Rochester20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Breast Cancer With Low to Intermediate HER2 Expression

Interventions

EchocardiogramPROCEDURE

12-lead echocardiogram

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Locations (1)

Wilmot Cancer Center

Rochester, New York, United States

RECRUITING

Outcomes

Primary Outcomes

Total Number of imaging tests

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

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

Time frame: end of therapy, approximately 457 days

Central Contacts

Kaily LaForce

CONTACT

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

Data from ClinicalTrials.gov

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