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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02772367
Recruitment Status : Recruiting
First Posted : May 13, 2016
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Breast Cancer Procedure: skin punch biopsy

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Generation of Induced Pluripotent Stem Cell Derived Cardiomyocytes From Patients Exposed to Trastuzumab Therapy for Breast Cancer
Study Start Date : May 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
skin tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772367


Contacts
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Contact: Angel Chan, MD, PhD 212-639-7217 chana5@mskcc.org
Contact: Richard Steingart, MD 212-639-8488

Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Angel Chan, MD, PhD    212-639-7217      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Angel Chan, MD, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02772367    
Other Study ID Numbers: 16-025
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
cardiotoxicity
16-025
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases