Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

70

Study ID:

NCT02772367

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States More Info
Angel Chan, MD, PhD
Contact
212-639-7217

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

70

Study ID:

NCT02772367

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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