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

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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

Tracking Information
First Submitted Date May 11, 2016
First Posted Date May 13, 2016
Last Update Posted Date July 23, 2020
Study Start Date May 2016
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2016)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients
Official Title Generation of Induced Pluripotent Stem Cell Derived Cardiomyocytes From Patients Exposed to Trastuzumab Therapy for Breast Cancer
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
skin tissue
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).
Condition Breast Cancer
Intervention Procedure: skin punch biopsy
Study Groups/Cohorts 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.
Intervention: Procedure: skin punch biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 14, 2018)
70
Original Estimated Enrollment
 (submitted: May 11, 2016)
6
Estimated Study Completion Date May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Angel Chan, MD, PhD 212-639-7217 chana5@mskcc.org
Contact: Richard Steingart, MD 212-639-8488
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02772367
Other Study ID Numbers 16-025
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Angel Chan, MD, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date July 2020