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Skin biopsies could reveal why breast cancer drugs harm the heart

NCT ID NCT02772367

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 takes a small skin sample from breast cancer patients who have received certain chemotherapies. Researchers will turn those skin cells into heart cells in a lab to study why some patients develop heart problems. The goal is to learn more about the link between treatment and heart damage, not to test a new treatment. 120 women will participate.

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 research could help identify which breast cancer patients are at risk for heart problems from certain chemotherapies, leading to safer treatment plans.
What could go wrong
This is an early-stage lab study, not a treatment trial. It may not translate into direct patient benefits, and findings might not apply to all patients.

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 120 people

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

Started

May 2016

Expected to finish

May 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

Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering Cancer Center (MSKCC).

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: * Female * Age greater than 18 years * Willing to participate in protocol procedures with signed informed consent * Assessment of LVEE via echocardiogram, cardiac MRI, or MUGA Subjects in the cardiotoxicity group (TOX) must meet the following criteria: * History of HER2 positive breast cancer (stage I-IV) * Prior/current treatment with anthracycline based chemotherapy followed by anti-HER2 directed therapy or anti-HER2 directed therapy alone * Assessment of LVEF at baseline prior to initiation of anthracycline or anti-HER2 therapy and during anti-HER2 therapy via echocardiogram, cardiac MRI, or MUGA * Prior confirmed diagnosis of cardiotoxicity associated with anti-HER2 based therapy, defined as a decrease in LVEF \> 10% from baseline to \< 53% with symptoms of heart failure (NYHA class II-IV). Subjects in the no cardiotoxicity group (NO-TOX) must meet the following criteria: * History of HER2 positive breast cancer (stage I-IV) * Completion of planned anthracycline and anti-HER2 therapy, or anti-HER2 therapy alone * No symptoms of heart failure (NYHA class II-IV) during and at the end of anthracycline and anti-HER2 therapy * Assessment of LVEF at baseline prior to innitiation of anthracycline or anti-HER2 therapy and during anti-HER2 therapy via echocardiogram, cardiac MRI, or MUGA * Normal LVEF \>53% at each assessment during and at the end of trastuzumab therapy. * Maximum absolute decrease in LVEF \<5% from baseline during and at the end of trastuzumab therapy. * LVEF assessment performed at baseline and at least two time points during trastuzumab therapy. Exclusion Criteria: * Unwilling or unable to give skin biopsies * Contraindications to punch biopsy including but not limited to bleeding diathesis, as determined by the investigator. * Known pre-existing CV disease prior to initiation of breast cancer therapy as determined by the investigator, including * Obstructive coronary artery disease (stenosis \>70%) * Arrhythmia - paroxysmal or persistent atrial arrhythmias, sustained ventricular tachycardia (\>30 seconds), ventricular fibrillation, or cardiac arrest * Cardiomyopathy (EF \<53%) * Heart failure (NYHA class II-IV) * Valvular heart disease with equal to or greater than moderate stenosis or regurgitation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Memorial Sloan-Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

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