Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/24/2019 |
| Start Date: | May 2016 |
| End Date: | May 2019 |
| Contact: | Richard Steingart, MD |
| Phone: | 212-639-8488 |
Generation of Induced Pluripotent Stem Cell Derived Cardiomyocytes From Patients Exposed to Trastuzumab Therapy for Breast Cancer
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.
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.
Inclusion Criteria:
- Female
- Age greater than 18 years
- Willing to participate in protocol procedures with signed informed consent
- Echocardiogram for assessment of LVEE
Subjects in the cardiotoxicity group (TOX) must meet the following criteria:
- History of non-metastatic HER2 positive breast cancer
- Prior/current treatment with anthracycline based chemotherapy followed by anti-HER2
directed therapy
- Echocardiogram pre and during anti-HER2 therapy for assessment of LVEE
- Prior confirmed diagnosis of symptomatic 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 non-metastatic HER2 positive breast cancer Completion of planned
anthracycline and anti-HER2 therapy
- No symptoms of heart failure (NYHA class II-IV) during and at the end of anthracycline
and anti-HER2 therapy
- Echocardiogram pre and during anti-HER2 therapy for assessment of LVEF
- 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.
Subjects in the healthy volunteer (NL) must meet the following criteria:
- No prior cardiac history
- Normal ECG and echocardiogram (LVEF >53%)
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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 212-639-8488
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials
