Transforming skin cells into heart muscle cells from breast cancer patients
Generation of Induced Pluripotent Stem Cell Derived Cardiomyocytes From Patients Exposed to Trastuzumab Therapy for Breast Cancer
This study is trying to see if skin cells from breast cancer patients can be turned into heart muscle cells to understand why some of these patients have heart problems after chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy, Doxorubicin |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT02772367 on ClinicalTrials.gov |
What this trial studies
This study investigates the transformation of skin cells from breast cancer patients into cardiomyocytes, which are heart muscle cells. By using a biopsy from the patient's skin, researchers aim to understand the structural and functional changes in these cells when cultured in a specialized medium. The focus is on patients who have experienced cardiotoxicity from chemotherapy treatments, particularly those involving anthracycline and anti-HER2 therapies. The study will analyze why some patients develop decreased heart function after such treatments.
Who should consider this trial
Good fit: Ideal candidates are female breast cancer patients over 18 years old who have a history of HER2 positive breast cancer and have experienced cardiotoxicity from treatment.
Not a fit: Patients who do not have HER2 positive breast cancer or have not undergone anthracycline or anti-HER2 therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to better understanding and management of heart function in breast cancer patients undergoing chemotherapy.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding cardiotoxicity in cancer treatments, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Angel Chan, MD, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Angel Chan, MD, PhD
- Email: chana5@mskcc.org
- Phone: 212-639-7217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.