Breast Cancer With Low to Intermediate HER2 Expression
Conditions
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).
Interventions
PROCEDUREEchocardiogram
12-lead echocardiogram
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 79 Years
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.
Design outcomes
Primary
| 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 |
Countries
United States
Contacts
CONTACTKaily LaForce
Outcome results
None listed