An interventional study of Intervention - Low Risk Group OR Intermediate Risk Group in Cardiovascular Health, Breast Cancer and Breast Cancer Early Stage Breast Cancer (Stage 1-3), sponsored by Women's College Hospital. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Women's College Hospital · Not applicable, Interventional, and Screening
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 300 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Women's College Hospital is the lead sponsor of 87 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pre-existing cardiovascular disease, defined as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Diagnostic Test: 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.
This study also gives Trastuzumab. No intervention listed here names it: that was found by reading the record.
Clinically overt heart failure
Determined as a binary event Y/N, per standardized definition
Time frame: From enrollment to <100days after end of treatment
Premature HER2TT discontinuation
Determined as a binary event Y/N, per clinical records
Time frame: From enrollment to <100days after end of treatment
Patient-reported outcome measures (PROMS) of anxiety/depression, stress, and treatment burden
Desirable outcome is a better scores in ≥2 of 3 PROMs-Treatment Burden Questionnaire, Hospital Anxiety and Depression Scale, Perceived Stress Scale
Time frame: From enrollment to <100 days after end of treatment
Asymptomatic cardiotoxicity at end of HER2TT
Per Cardiac Review and Evaluation Committee criteria, based on LVEF change
Time frame: From enrollment to <100 days after the end of treatment
Time to complete HER2TT
Number weeks from first HER2TT cycle to last (shorter is better)
Time frame: From enrollment to <100 days after the end of treatment
Total number of cardiac imaging tests during HER2TT
Number of LVEF assessments (fewer is better)
Time frame: From enrollment to <100 days after the end of treatment
Absolute change in percentage of LVEF
Based on cardiac imaging. Analyzed for non-inferiority of judicious imaging versus standard of care
Time frame: From baseline imaging to one year
Desirability Ratio
Limited to primary outcomes 1-5 (excluding the number of cardiac imaging tests)
Time frame: From enrollment to <100 days after the end of treatment
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Jun 2029, 38 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 38 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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