Back to search results

Studying Heart Health in Breast Cancer Patients

This observational study aims to understand why some breast cancer patients treated with chemotherapy, specifically anthracycline-based drugs like Doxorubicin and anti-HER2 therapy like Herceptin, develop heart problems. Researchers will take a small skin sample (skin punch biopsy) from participants. They will then turn these skin cells into heart muscle cells (cardiomyocytes) in a lab. By studying these lab-grown heart cells, they hope to learn more about how these treatments affect heart function. The study is looking for 120 women over 18 years old who have HER2-positive breast cancer and have received anthracycline-based chemotherapy. The main goal is to successfully create these heart cells from skin cells within one day. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 120 women. It is not a treatment study, but rather aims to understand how certain breast cancer treatments affect the heart.
What's involved
You would undergo a skin punch biopsy. Your heart function would be assessed via echocardiogram, cardiac MRI, or MUGA.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, deriving iPSs from skin fibroblasts, is measured at 1 day. Further follow-up information is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02772367

Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients

Recruiting
Not specifiedAges 18+Observational
Memorial Sloan Kettering Cancer Center
~120 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:skin punch biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
derive iPSs from skin fibroblasts
Measured over 1 day

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Angel Chan, MD, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Angel Chan, MD, PhD
[email protected]
212-639-7217
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
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).
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

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

What this trial measures

  • derive iPSs from skin fibroblasts1 day

    described by Yamanaka et al with modification using the Millipore STEMCCA excisable polycystronic lentivirus reprogramming kit.2