TRPC6 Characterization to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure With Breast Cancer
Recruiting · NCT05507879 · Observational (researchers observe without assigning treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed across 1 US state.
- University of Florida - Gainesville, Florida, United States
- Mayo Clinic in Florida - Jacksonville, Florida, United States