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

Conditions

• Breast Cancer With Low to Intermediate HER2 Expression

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• Echocardiogram — PROCEDURE
  12-lead echocardiogram

Study Details

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).

Key Dates

Start date

Nov 17, 2025

Status verified

Jun 2026

Primary completion

Jun 30, 2031

Completion

Jun 30, 2031

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• 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).

Primary Outcome Measure

Total Number of imaging tests [ Time Frame: At the end of therapy, approximately 457 days ]

Central Contacts

• Kaily LaForce
  585-274-2808
  [email protected]

Locations (1)

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