RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2016-05-11

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02772367

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Angel Chan, MD, PhD

CONTACT

212-639-7217

chana5@mskcc.org

Richard Steingart, MD

CONTACT

212-639-8488

Principal Investigator

Angel Chan, MD, PhD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-05-11

Study Completion Date2026-05

Study Record Updates

Study Start Date2016-05-11

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

cardiotoxicity
16-025

Additional Relevant MeSH Terms

Breast Cancer