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

NCT02772367 | Recruiting

• 1 other identifier: 16-025
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

cardiotoxicity; 16-025

Outcome Measures

Primary Outcomes (1)

• derive iPSs from skin fibroblasts

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

  1 day

Study Arms (1)

Breast Cancer Patients

In study participants undergoing breast reconstruction surgery prior to breast radiation therapy, we will obtain skin tissue at the time of reconstruction surgery from the surgical specimen.

Procedure: skin punch biopsy

Interventions

skin punch biopsy PROCEDURE

Breast Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering Cancer Center (MSKCC).

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITHOUT DNA

skin tissue

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Angel Chan, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angel Chan, MD, PhD

CONTACT

212-639-7217; chana5@mskcc.org

Richard Steingart, MD

CONTACT

212-639-8488

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 13, 2016
• Study Start: May 11, 2016
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

US (1)