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TRPC6 Characterization to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure With Breast Cancer

Characterization of TRPC6 to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure (Prospective Study)

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
All sexes
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: Blood draws

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
  • "Patients undergo collection of blood samples at time of enrollment."
  • "Patients who develop cardiac toxicity may undergo additional collection of blood samples."
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 looks at TRPC6 to learn if it can help predict and prevent heart damage from breast cancer treatment. Researchers will study blood samples to look for DNA changes and signs of heart damage. The study includes people with breast cancer and healthy adults.

This study examines TRPC6 in predicting and preventing chemotherapy related cardiac toxicity and heart failure in patients with breast cancer. Cardiac toxicity, changes in heart function is a well-recognized complication of certain cancer related therapies. Understanding these changes may allow early intervention against therapy-related cardiac toxicity and also identify novel therapeutic targets to protect patient long-term cardiac health. Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA), identify biomarkers related to cardiac toxicity, and prevent the development of therapy-induced cardiac toxicity in patients receiving chemotherapy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have breast cancer and be starting doxorubicin or a similar drug, or receiving trastuzumab without these drugs, before or after surgery.
  • Understand the study, what you must do, and its risks and discomforts.
  • Be able and willing to sign a form agreeing to join the study.
  • Meet one of these treatment conditions: have heart or blood vessel problems possibly caused by past cancer treatment; have finished chemotherapy at least 2 years ago with no heart damage; or be about to start cancer drugs that may harm the heart.
  • Healthy volunteers must be adults, not pregnant, and weigh at least 110 pounds.

Who can't join

  • Cannot understand the form agreeing to join or follow the study's rules.
  • Have anemia (too few healthy red blood cells) with a hemoglobin level below 8.
  • Are not willing to have blood drawn.
  • Have stage IV breast cancer, meaning cancer that has spread to distant parts of the body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 18 years of age or older * Any breast cancer patient initiating doxorubicin/other anthracycline and patients receiving trastuzumab without doxorubicin/anthracycline in the neoadjuvant/adjuvant setting * An understanding of the protocol and its requirements, risks, and discomforts * The ability and willingness to sign an informed consent * Diagnosed with therapy related cardiotoxicity defined as; cardiomyopathy, symptomatic heart failure, asymptomatic reduced systolic function, acute coronary syndrome, myocardial infarction, critical limb ischemia, cardiac arrhythmias or myocarditis possibly related to prior cancer treatment OR completed chemotherapy with no cardiotoxicity at least two years post treatment OR patients with cancer who will be initiating systemic therapy with potentially cardiotoxic medications. This will include doxorubicin chemotherapy, or trastuzumab. * Healthy, non-pregnant, adult subjects who weigh at least 110 pounds Exclusion Criteria: * Inability on the part of the patient to understand the informed consent or be compliant with the protocol * Anemia with hemoglobin less than 8 * Patients not willing to undergo a blood draw * Patients with stage IV or distant metastatic breast cancer

Study sites (2)

FL