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Recruiting NCT07630402

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

No phase Interventional Breast Cancer With Low to Intermediate HER2 Expression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Echocardiogram.
Who it may be relevant to
Registry conditions: Breast Cancer With Low to Intermediate HER2 Expression. Basic parameters: 18 years — 79 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

Interventions

  • Procedure Echocardiogram
    12-lead echocardiogram

Primary outcome measures

  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Wilmot Cancer Center — Rochester

Identifiers

NCT: NCT07630402 · STUDY00010778

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗