Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT05507879

Conditions

Breast Carcinoma

Cardiomyopathy

Congestive Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Electronic Medical Record

Study Details

Brief summary:

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.

Conditions

Breast Carcinoma

Cardiomyopathy

Congestive Heart Failure

Study ID

NCT05507879

Start date

Sep 26, 2022

Status verified date

Aug, 2026

Completion date

Jul 1, 2030

Anticipated

Primary completion date

Jul 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Ancillary-Correlative (biospecimen collection)

Patients undergo collection of blood samples at time of therapy initiation. Patients who develop cardiac toxicity may undergo additional collection of blood samples. Patients' medical records are also reviewed.

Interventions

Biospecimen Collection

Undergo collection of blood samples

Electronic Medical Record

Review of medical records

Primary outcome measure

  • Significance ofTRPC6 coding sequencing [ Time Frame: Up to study completion, up to four years to completion. ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Katelyn Bruno, Ph.D.

352-273-8933katelyn.bruno@ufl.edu

Principal Investigator:

Katelyn Bruno, Ph.D.

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trial Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Nadine Norton, Ph.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-05.