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Breast cancer Drug's hidden heart risks under the microscope

NCT ID NCT06781762

Knowledge-focused Sponsor: University of Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tracks 40 postmenopausal women with hormone-positive breast cancer who are starting aromatase inhibitor therapy. Researchers will measure heart and blood vessel health, blood markers, body composition, and lifestyle factors over 6 months, comparing them to healthy women of the same age and weight. The goal is to understand why these drugs increase heart risks over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aromatase inhibitors
What this could lead to
If successful, this study could help doctors better monitor and prevent heart problems in breast cancer patients taking aromatase inhibitors.
What could go wrong
This is a small observational study with only 40 participants, so results may not apply to everyone. It does not test a new treatment, only measures existing side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Case participants will be recruited from Princess Margaret Cancer Centre in Toronto. Control participants will be local participants in the greater Toronto area, recruited through posters, newsletters, social media advertisements, and word of mouth.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Case group: * Biologically female * Post-menopausal with natural (no bilateral oophorectomy) amenorrhea for at least 1 year * If using hormone replacement therapy, limit of a maximum of 3 years of treatment but not within the last 6 months. * Diagnosis of stage I, II, or III breast cancer * Hormone receptor positive breast cancer * HER negative (ER+/PR+/HER-) breast cancer * Confirmed to start aromatase inhibitor therapy for the first time in next 2-3 months * Received surgery/radiation therapies Control group: * Biologically female * Post-menopausal with natural (no bilateral oophorectomy) amenorrhea for at least 1 year * If using hormone replacement therapy, limit of a maximum of 3 years of treatment but not within the last 6 months. Exclusion Criteria: * Previous treatment using tamoxifen endocrine therapy in a pre-or peri-menopausal setting * Major signs or symptoms of cardiovascular diseases, diabetes, or renal disease (taken from the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription 11th edition Table 2.1: pain or discomfort in the chest, neck, jaw, arms with rest or exercise, shortness of breath at rest or with mild exertion, dizziness or syncope, loss of balance or passing out, ankle edema, palpitations or tachycardia, intermittent claudication, known heart murmur, unusual fatigue with usual activities.) * American Heart Association's absolute or relative contraindications for symptom-limited maximal exercise testing (myocardial infarction, aortic or coronary artery stenosis, heart failure, pulmonary embolism or deep vein thrombosis, inflammation of the heart (myocarditis, pericarditis, and/or endocarditis), uncontrolled cardiac arrythmia, advanced or complete electrical heart block, stroke or transient ischemia attack, blood pressure \>200mmHg/100mmHg, a cancer diagnosis other than skin cancer) * Unable to provide informed consent or communicate in English * Mobility limitations to exercise testing (i.e., wheelchair, walker use, limp impeding walking) * Extreme claustrophobia

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Conditions

The condition(s) this trial relates to.

breast cancer female breast carcinoma Obesity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer females

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Toronto

    RECRUITING

    Toronto, Ontario, M5S2C9, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.