Understanding TRPC6 to Prevent Heart Issues in Breast Cancer Patients Receiving Chemotherapy
Characterization of TRPC6 to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure (Prospective Study)
This study is trying to see if looking at a specific gene can help prevent heart problems in breast cancer patients who are getting chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy, doxorubicin |
| Locations | 2 sites (Gainesville, Florida and 1 other locations) |
| Trial ID | NCT05507879 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the TRPC6 gene to predict and prevent cardiac toxicity and heart failure in patients undergoing chemotherapy for breast cancer. By collecting blood samples from patients, the study aims to identify genetic variants associated with doxorubicin-related cardiotoxicity and monitor changes in heart function. The research will also review patients' medical records to gather comprehensive data on cardiac health. The ultimate goal is to enable early interventions and identify new therapeutic targets to protect long-term cardiac health in these patients.
Who should consider this trial
Good fit: Ideal candidates include adult breast cancer patients starting treatment with doxorubicin or trastuzumab, particularly those at risk for cardiac toxicity.
Not a fit: Patients who are not undergoing chemotherapy or those with pre-existing severe cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing heart-related complications in breast cancer patients undergoing chemotherapy.
How similar studies have performed: Other studies have explored genetic factors in chemotherapy-related cardiotoxicity, suggesting potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gainesville, Florida and 1 other locations
- University of Florida — Gainesville, Florida, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Nadine Norton, Ph.D. — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
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.