RecruitingNCT06388122
DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients
Sponsor
Mayo Clinic
Enrollment
100 participants
Start Date
Apr 30, 2024
Study Type
OBSERVATIONAL
Conditions
Metastatic Breast CancerHER2-Negative Breast CarcinomaHER2-negative Breast CancerAnatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Metastatic Breast CarcinomaHormone Receptor-Positive Breast CancerHormone Receptor-Positive Breast Carcinoma
Summary
This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4/6 inhibitor used for hormone receptor positive HER2 negative breast cancer.
Eligibility
Sex: FEMALEMin Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This is an observational study (no experimental treatment) that tracks a blood-based test called DiviTum TKa to see if it can predict how well hormone-receptor-positive (HR+) metastatic breast cancer responds to CDK4/6 inhibitor drugs (like palbociclib, ribociclib, or abemaciclib).
**You may be eligible if...**
- You are a woman (pre- or post-menopausal) with HR+ metastatic breast cancer
- You are starting or already receiving a CDK4/6 inhibitor drug with or without hormone therapy, OR you are starting a hormone therapy alone for metastatic disease
**You may NOT be eligible if...**
- You are using an experimental/investigational treatment
- You have early-stage (not metastatic) breast cancer
- You are male
- You are being actively treated for another cancer
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
PROCEDUREBiospecimen Collection
Undergo blood sample collection
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06388122
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