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NCT02772367
Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients
Conditions: Breast Cancer
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 120
Sponsor: Memorial Sloan Kettering Cancer Center
Location: Memorial Sloan-Kettering Cancer Center New York New York
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.
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 \70%)
* Arrhythmia - paroxysmal or persistent atrial arrhythmias, sustained ventricular tachycardia (\>30 seconds), ventricular fibrillation, or cardiac arrest
* Cardiomyopathy (EF \
Source: ClinicalTrials.gov (NCT02772367). StuddyBuddy aggregates publicly available trial information.
