JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year

NCT ID: NCT06930521

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2033-06-30

Brief Summary

This study focuses on male and female patients being treated for breast cancer that is positive for the HER2 receptor which requires special treatments targeting that receptor. The problem is that these treatments, while effective for the cancer, can sometimes harm the heart. Because of this, patients have to undergo heart tests every three months during treatment, even if they have no history of heart disease or feel fine.

The guidelines for these regular heart tests were established decades ago when these treatments were first introduced, but research shows that most of these tests don't actually change the treatment plan. This suggests that many patients are going through unnecessary tests, which can cause stress, delay treatments, and increase healthcare costs.

To address this, the researchers propose a new study with 300 patients with HER2 positive breast cancer to test a more personalized approach to cardiac surveillance. Participants will be classified based on their risk of heart problems: low or intermediate. Instead of testing every patient every three months, those in the intermediate group will be tested every 4 months, and those in the low-risk group will be tested every 6 months. The researchers will compare this new approach to the current system to see if fewer tests are just as safe and effective.

The researchers will measure heart health, how well cancer treatments are completed, and how patients feel about having fewer tests. If this new approach works, it could save money and reduce the burden on female patients without risking their health.

Conditions

Cardiovascular Health; Breast Cancer; Breast Cancer Early Stage Breast Cancer (Stage 1-3); Cardio-oncology; Circulatory and Respiratory Health; Clinical and Translational Cardiovascular Sciences; Health Services and Systems - Healthcare Effectiveness &Amp; Outcomes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Standard of Care

The SOC arm will receive imaging before cycles 1, 5, 9, and 13 (in keeping with the FDA product label), then at the end of HER2-TT, i.e., imaging every 3 months for uninterrupted adjuvant HER2TT.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Judicious Imaging

This group will get less echocardiograms based on their risk of developing heart failure. People who do not have any issues that predispose to heart failure are categorized as low risk and will get an echocardiogram once every 6 months. People who have factors that may predispose to heart failure are categorized as intermediate risk and will get an echocardiogram approximately once every 4 months.

Group Type: EXPERIMENTAL

Intervention - Low Risk Group OR Intermediate Risk Group

Intervention Type: DIAGNOSTIC_TEST

Participants will be randomized to judicious imaging (decreased imaging frequency based on HF risk category) or SOC (imaging every 3 months). Participants who do not have any HF risk factors will be categorized as low risk, while participants with at least one risk factor will be categorized as intermediate risk for HF.

Low Risk (zero risk factors): imaging before cycles 1 and 9 of HER2-TT (i.e., at baseline and near the halfway mark, corresponding to 2 fewer studies than SOC in Year 1), then after the end of HER2TT. This translates to imaging every 6 months for uninterrupted adjuvant HER2TT.

Intermediate Risk (any risk factors): imaging before cycles 1, 6, and 12 of HER2-TT (i.e., at baseline and near the 1/3 and 2/3 marks, corresponding to 1 fewer study than SOC in Year 1), then at end of HER2TT. This translates to imaging every 4 months for uninterrupted adjuvant HER2TT.

Interventions

Intervention - Low Risk Group OR Intermediate Risk Group

Participants will be randomized to judicious imaging (decreased imaging frequency based on HF risk category) or SOC (imaging every 3 months). Participants who do not have any HF risk factors will be categorized as low risk, while participants with at least one risk factor will be categorized as intermediate risk for HF.

Low Risk (zero risk factors): imaging before cycles 1 and 9 of HER2-TT (i.e., at baseline and near the halfway mark, corresponding to 2 fewer studies than SOC in Year 1), then after the end of HER2TT. This translates to imaging every 6 months for uninterrupted adjuvant HER2TT.

Intermediate Risk (any risk factors): imaging before cycles 1, 6, and 12 of HER2-TT (i.e., at baseline and near the 1/3 and 2/3 marks, corresponding to 1 fewer study than SOC in Year 1), then at end of HER2TT. This translates to imaging every 4 months for uninterrupted adjuvant HER2TT.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Stage 1-3 breast cancer (BC).

2. Age 18-79 years.

3. HER-2 positive BC with planned HER2 targeted therapy (HER2TT) for curative intent.

Exclusion Criteria

1. Distant metastases detected clinically, radiographically, or histologically

2. Baseline echocardiogram images of insufficient quality for a quantitative assessment of left ventricular ejection fraction (LVEF)

3. Pre-existing cardiovascular disease, defined as:

1. Prior myocardial infarction (even if LVEF has normalized)

2. Prior heart failure (HF, including patients with preserved ejection fraction and normalized LVEF)

3. Baseline LVEF <55%

4. Atrial fibrillation

5. Greater than moderate valvular disease (i.e., severe, or moderate-severe)

4. Cumulative anthracycline exposure ≥250mg/m2 before starting HER2TT

5. New York Heart Association Functional Class II, III or IV, or Eastern Cooperative Oncology Group score >2*

6. Symptoms potentially due to serious cardiac disease as per investigator's judgement* *Exclusion criterion adopted as they make clinical assessment less reliable to detect emergent HF.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Husam Abdel-Qadir

Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Women's College Hospital

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Husam Abdel-Qadir, MD, PhD, FRCPC

Role: CONTACT

husam.abdel-qadir@wchospital.ca

416-323-7723

Facility Contacts

Faiza Ishrat

Role: primary

faiza.ishrat@wchospital.ca

416-323-6400 x 2420

Other Identifiers

5034

Identifier Type: -

Identifier Source: org_study_id