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Study seeks best heart check schedule for breast cancer drug

NCT ID NCT02696707

Knowledge-focused Sponsor: Ottawa Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 200 women with early-stage HER2-positive breast cancer who were taking trastuzumab. The goal was to compare two standard schedules for monitoring heart function: every 3 months versus every 4 months. Researchers wanted to see if less frequent monitoring could be safe and effective, since trastuzumab can sometimes cause heart damage.

What this could mean

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

What this could lead to
If successful, this could help doctors choose the safest and most efficient heart monitoring schedule for breast cancer patients on trastuzumab.
What could go wrong
This is a small, completed study comparing existing standard-of-care schedules, not testing a new treatment. Results may not change current practice.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

200 people

The number who actually took part.

Start date

Jun 2016

Finished

Jul 2020

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Histologically confirmed early stage HER2-positive breast cancer * Planned trastuzumab therapy for early stage breast cancer * ≥18 years of age * Able to provide verbal consent * Normal LVEF (\>53%) before trastuzumab therapy Exclusion Criteria: • Contraindication to transthoracic echocardiography or MUGA

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Cardiotoxicity HER2 positive breast carcinoma

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9, Canada

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6, Canada

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K2H 8L6, Canada

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7B 6V4, Canada

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