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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05507879
• Other study ID #: 22-001501
• Secondary ID: NCI-2022-05690P3
• Status: Recruiting
• Start date: August 18, 2022
• Est. completion date: September 1, 2027

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE:

I. Characterize TRPC6 risk variants for doxorubicin-related cardiotoxicity in prospectively collected samples from breast cancer patients.

OUTLINE: This is an ancillary-correlative study.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Cardiomyopathies
• Cardiotoxicity
• Heart Failure

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood samples

Other:
• Electronic Medical Record
Review of medical records

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significance ofTRPC6 coding sequencing	Will compare the prevalence of rare missense variants in our cases against the null hypothesis to assess the significance of TRPC6 coding sequencing data in patients with dox-induced heart failure (HF). Will use an exploratory analysis to estimate the prevalence, 95% confidence intervals and p-values depending on the number of patients with rare variants in the data set and due to the rarity (i.e. high degree of conservation in the TRPC6 coding sequence).Other methods include biospecimen collection and the TRPC6 coding sequence. Data collected will be stored in a database and studied by the PI.	Up to study completion, up to four years to completion.