Actively Recruiting
Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-07-16
120
Participants Needed
1
Research Sites
520 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
I
Icahn School of Medicine at Mount Sinai
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to investigate whether cells from a biopsy taken from the patient skin can be transformed into cardiomyocytes the changes in cardiomyocyte (heart muscle cells) when grown in a special culture medium outside of the body. The structure and function of these cells will then be studied to determine why some patients with breast cancer who are treated with chemotherapy including anthracycline (e.g. Doxorubicin) and anti-HER2 therapy (e.g. Herceptin) develop decreased heart function.
CONDITIONS
Official Title
Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age greater than 18 years
- Willing to participate in protocol procedures with signed informed consent
- Assessment of left ventricular ejection fraction (LVEF) via echocardiogram, cardiac MRI, or MUGA
- History of HER2 positive breast cancer (stage I-IV)
- Prior or current treatment with anthracycline-based chemotherapy followed by anti-HER2 therapy or anti-HER2 therapy alone (cardiotoxicity group)
- Assessment of LVEF at baseline before starting anthracycline or anti-HER2 therapy and during anti-HER2 therapy
- Prior confirmed diagnosis of cardiotoxicity related to anti-HER2 therapy, defined as a decrease in LVEF > 10% from baseline to < 53% with symptoms of heart failure (NYHA class II-IV) (cardiotoxicity group)
- Completion of planned anthracycline and anti-HER2 therapy, or anti-HER2 therapy alone (no cardiotoxicity group)
- No symptoms of heart failure (NYHA class II-IV) during and after therapy (no cardiotoxicity group)
- Normal LVEF >53% at each assessment during and at the end of trastuzumab therapy (no cardiotoxicity group)
- Maximum absolute decrease in LVEF <5% from baseline during and at the end of trastuzumab therapy (no cardiotoxicity group)
- LVEF assessment performed at baseline and at least two time points during trastuzumab therapy (no cardiotoxicity group)
You will not qualify if you...
- Unwilling or unable to give skin biopsies
- Contraindications to punch biopsy including bleeding disorders
- Known pre-existing cardiovascular disease before starting breast cancer therapy, including:
- Obstructive coronary artery disease with stenosis >70%
- Paroxysmal or persistent atrial arrhythmias, sustained ventricular tachycardia (>30 seconds), ventricular fibrillation, or cardiac arrest
- Cardiomyopathy with ejection fraction <53%
- Heart failure classified as NYHA class II-IV
- Valvular heart disease with moderate or greater stenosis or regurgitation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
A
Angel Chan, MD, PhD
CONTACT
R
Richard Steingart, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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