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

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.

Conditions

Breast Cancer

Study Overview

Study Details

Study overview

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.

Generation of Induced Pluripotent Stem Cell Derived Cardiomyocytes From Patients Exposed to Trastuzumab Therapy for Breast Cancer

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

New York

Memorial Sloan-Kettering Cancer Center, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

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

Study Record Dates

2026-05