Pilot Study for Optimization of Cardiac Imaging in Women With Early-Stage Breast Cancer
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:
• 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.
Locations
United States
New York
Wilmot Cancer Center
RECRUITING
Rochester
Contact Information
Primary
Kaily LaForce
kaily_laforce@urmc.rochester.edu
585-274-2808
Time Frame
Start Date: 2025-11-17
Estimated Completion Date: 2031-06-30
Participants
Target number of participants: 20
Treatments
Active_comparator: Standard-of-care Group
Participants in this group will receive echocardiogram imaging before cycles 1, 5, 9, and 13 of trastuzumab (or every 3 months) and another echocardiogram after completion of trastuzumab (within 100 days after completion of HER2-TT).
Experimental: Judicious-imaging Group
The Judicious Imaging Group will get split into two separate subgroups, intermediate-risk or low-risk, depending on their risk of heart failure, which will determine how many echocardiograms they will receive. The low-risk subgroup will get an echocardiogram once every 6 months (before cycles 1 and 9 and after the completion of trastuzumab). The intermediate-risk subgroup will get an echocardiogram approximately once every 4 months (before cycles 1, 6, and 12 and after completion of trastuzumab).
Related Therapeutic Areas
Sponsors
Leads: University of Rochester