Recruiting

Personalized Cardiac Surveillance

Sponsor:

Women's College Hospital

Code:

NCT06930521

Conditions

Cardiovascular Health

Breast Cancer

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Cardio-oncology

Circulatory and Respiratory Health

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intervention - Low Risk Group OR Intermediate Risk Group

Study Details

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

Study ID

NCT06930521

Start date

Apr 22, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2033

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

no intervention: 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.

experimental: 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.

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.

Primary outcome measure

  • Clinically overt heart failure [ Time Frame: From enrollment to <100days after end of treatment ]
  • Premature HER2TT discontinuation [ Time Frame: From enrollment to <100days after end of treatment ]
  • Patient-reported outcome measures (PROMS) of anxiety/depression, stress, and treatment burden [ Time Frame: From enrollment to <100 days after end of treatment ]
  • Asymptomatic cardiotoxicity at end of HER2TT [ Time Frame: From enrollment to <100 days after the end of treatment ]
  • Time to complete HER2TT [ Time Frame: From enrollment to <100 days after the end of treatment ]
  • Total number of cardiac imaging tests during HER2TT [ Time Frame: From enrollment to <100 days after the end of treatment ]

Central Contacts and Locations

Central contacts

Husam Abdel-Qadir, MD, PhD, FRCPC

416-323-7723husam.abdel-qadir@wchospital.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Priyancee Sabhaya, MSc

437-522-6441Priyancee.Sabhaya2@uhn.ca

Principal Investigator:

Husam Abdel-Qadir, MD, PhD

More Information

Sponsor

Women's College Hospital

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Trastuzumab
  • Cardiac imaging
  • Her-2 positive breast cancer
  • Echocardiography
  • Cardiotoxicity
  • Left ventricular ejection fraction
  • Heart failure
  • Randomized controlled trial
  • Nuclear imaging
  • Non-inferiority

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women's College Hospital on 2026-06-15.