Heart Muscle Cell Study for Breast Cancer Patients
Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients
Recruiting
Observational Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
120 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
This trial is looking for women with breast cancer to help understand how certain treatments affect heart muscle cells. Participants will provide skin samples and have their heart function assessed over time.
Are You a Good Fit for This Trial?
You may be able to join if
I am a female.
I am over 18 years old.
I am willing to participate in study procedures.
I have a history of HER2 positive breast cancer.
I have been treated with anthracycline chemotherapy or anti-HER2 therapy.
I have had my heart function assessed by echocardiogram or similar methods.
You may not be able to join if
I am unwilling or unable to provide skin samples.
I have a history of severe bleeding disorders.
I have pre-existing heart disease.
I have obstructive coronary artery disease.
I have had serious heart rhythm issues.
I have cardiomyopathy.
I have heart failure.
I have significant heart valve problems.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 incl…
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.
Trial Locations
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Status
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 positi…
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
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