TRPC6 Characterization to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure With Breast Cancer
NCT ID: NCT05507879
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2022-09-26
2027-09-01
Brief Summary
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Detailed Description
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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 enrollment. Patients who develop cardiac toxicity may undergo additional collection of blood samples. Patients' medical records are also reviewed.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Biospecimen Collection
Undergo collection of blood samples
Electronic Medical Record
Review of medical records
Interventions
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Biospecimen Collection
Undergo collection of blood samples
Electronic Medical Record
Review of medical records
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Anemia with hemoglobin less than 8
* Patients not willing to undergo a blood draw
* Patients with stage IV or distant metastatic breast cancer
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Nadine Norton, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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University of Florida
Gainesville, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2022-05690
Identifier Type: REGISTRY
Identifier Source: secondary_id
W81XWH-22-1-0289
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
22-001501
Identifier Type: -
Identifier Source: org_study_id