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Study questions need for frequent heart checks in breast cancer therapy

NCT ID NCT03983382

Knowledge-focused Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looks at whether people with HER2-positive breast cancer can safely have fewer heart check-ups while on a specific type of treatment (trastuzumab without anthracyclines). About 190 participants will be followed to see if less monitoring leads to serious heart problems. The goal is to make treatment less burdensome without compromising safety.

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

190 people

The number who actually took part.

Started

Mar 2019

Expected to finish

Mar 2027

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

A member of the patient's treatment team, the protocol investigator, or research team at MSK will identify potential research participants. The preliminary screen of eligibility will be confirmation of the diagnosis of HER2-positive breast cancer. A member of the treatment team will discuss the study and the possibility of enrollment in the study with potential subjects that meet this eligibility criterion. The study will be conducted at the Evelyn H. Lauder Breast Center of MSK as well as at the regional MSK network sites. Recruitment at both main and regional network sites will ensure the enrollment of diverse populations of different ages, races, and ethnic groups onto the study. Patients will then be consented to the study. In most cases, the initial contact with the prospective subject will be conducted either by the treatment team, investigator or the research staff working in consultation with the treatment team.

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: * Age \>/= 18 years * Newly diagnosed histologically confirmed primary invasive breast carcinoma (Stage I-IV) * Pathologically confirmed HER2-positive breast cancer * Planned to receive trastuzumab-based therapy for a minimum of 12 months, or started trastuzumab-based therapy within the last weeks with a planned duration of at least 12 months. * Normal LV systolic function (EF greater than or equal to the institutional lower limit of normal) * William and able to comply with the requirements of the protocol Exclusion Criteria: * Planned to receive an anthracycline-based regimen * Prior history of treatment with anthracycline chemotherapy * History of cardiovascular including cardiomyopathy, heart failure, or any other clinically significant cardiovascular disease (as determined by the investigator) * Uncontrolled hypertension, defined as systolic blood pressure \>/= 160 mmHg and/or diastolic blood pressure \>/= 90 mmHg (as determined by the investigator)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm 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

  • Hartford Healthcare Cancer Institute @ Hartford Hospital (Data collection only)

    Hartford, Connecticut, 06102, United States

  • Memorial Sloan Kettering Bergen (Consent and follow-up only)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center @ BaskingRidge (Consent and follow-up only)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Cancer Center @ Commack (Consent and Follow up)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (Consent and Follow up)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Consent and Follow-up)

    Rockville Centre, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (Consent and Follow-up)

    Harrison, New York, 10604, United States

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