Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients
Generation of Induced Pluripotent Stem Cell Derived Cardiomyocytes From Patients Exposed to Trastuzumab Therapy for Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether skin cells can be turned into heart muscle cells and grown outside the body. Researchers will study these cells to learn why some breast cancer treatments weaken the heart. It is for women over 18 with HER2-positive breast cancer, with or without heart damage from treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must be female and older than 18.
- You must agree to the study procedures and sign a consent form.
- You must have a history of stage I–IV HER2-positive breast cancer, a cancer with high levels of a protein called HER2.
- You must have heart scans before and during HER2-targeted treatment to measure LVEF, the amount of blood the heart pumps out with each beat.
- For the heart damage group: You must have had or be receiving HER2-targeted treatment, either alone or after anthracycline chemotherapy.
- For the heart damage group: HER2-targeted treatment must have caused confirmed heart damage with heart failure symptoms. LVEF must have dropped by more than 10 percentage points to below 53%.
- For the group without heart damage: You must have finished planned HER2-targeted treatment, either alone or with anthracycline chemotherapy, with no heart failure symptoms during or at the end of treatment.
- For the group without heart damage: LVEF must stay above 53% and drop less than 5 percentage points during and at the end of trastuzumab (Herceptin) treatment. Scans are required before treatment and at least twice during treatment.
Who can't join
- You cannot or do not want to give small skin samples, called biopsies.
- The study doctor decides a skin biopsy is unsafe for you, including because of a condition that causes easy bleeding.
- Before breast cancer treatment, you had a heart artery narrowed by more than 70%.
- Before breast cancer treatment, you had certain abnormal heart rhythms, including upper-chamber rhythm problems or a fast lower-chamber rhythm lasting over 30 seconds.
- Before breast cancer treatment, you had ventricular fibrillation, a dangerous heart rhythm, or your heart stopped beating.
- Before breast cancer treatment, you had weakened heart muscle with a pumping measure below 53%.
- Before breast cancer treatment, you had heart failure with symptoms.
- Before breast cancer treatment, you had a heart valve with at least moderate narrowing or leaking.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 sites (1)
NY
- Memorial Sloan-Kettering Cancer Center · New York, NY 10065Angel Chan, MD, PhD · Study contact · 212-639-7217More trials in New York