Recruiting

HER2-TT

Sponsor:

University of Rochester

Code:

NCT07630402

Conditions

Breast Cancer With Low to Intermediate HER2 Expression

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Echocardiogram

Study Details

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).

Conditions

Breast Cancer With Low to Intermediate HER2 Expression

Study ID

NCT07630402

Start date

Nov 17, 2025

Status verified date

Jun, 2026

Completion date

Jun 30, 2031

Anticipated

Primary completion date

Jun 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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).

Interventions

Echocardiogram

12-lead echocardiogram

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kaily LaForce

585-274-2808kaily_laforce@urmc.rochester.edu

Locations

Wilmot Cancer Center

Recruiting

Rochester, New York, United States, 14642

Principal Investigator:

Farhan Bajwa, MD, FACC

More Information

Sponsor

University of Rochester

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-06-05.