NCT02772367 · Memorial Sloan Kettering Cancer Center
Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients
What this study 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.
View original scientific description
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.
Interventions
PROCEDURE
skin punch biopsy
Primary outcome measures
derive iPSs from skin fibroblasts
Time frame: 1 day
described by Yamanaka et al with modification using the Millipore STEMCCA excisable polycystronic lentivirus reprogramming kit.2
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- New York, New York
Collaborators
Icahn School of Medicine at Mount Sinai
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations