Optimization of Cardiac Imaging in Women With Early-Stage Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-79
SponsorUniversity of Rochester
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Prior HF, myocardial infarction, or cardiomyopathy.
Atrial fibrillation or significant valvular heart disease.
Cumulative anthracycline dose ≥ 250 mg/m².
Pregnancy or lactation.
Trial design
Design model
Parallel
Treatments tested in this trial
Echocardiogram
Procedure/Surgery12-lead echocardiogram
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Standard-of-care GroupActive comparator 1 intervention
Group B: Judicious-imaging GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Total Number of imaging tests
Time frame
At the end of therapy, approximately 457 days2
Time to completion of HER 2 (human epidermal growth factor receptor 2) target therapy in days
Time frame
end of therapy, approximately 457 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov