Actively Recruiting
DiviTum4TKa Biomarker Assay Study for Efficacy in Hormone Receptor-Positive Breast Cancer Patients
Led by Mayo Clinic · Updated on 2026-06-01
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patterns in how patients with hormone receptor-positive (HR+) and HER2-negative breast cancer respond to endocrine therapy alone or combined with CDK4/6 inhibitors. This study focuses on patients with metastatic or advanced breast cancer, aiming to identify biomarkers that may predict treatment resistance. The study is observational and sponsored by Mayo Clinic. Participants include various groups based on their treatment stage: those starting first or later lines of CDK4/6 inhibitor therapy combined with endocrine therapy, those already receiving first-line combination therapy, those on first or second line endocrine therapy alone, and those receiving adjuvant therapy for stage II or III breast cancer. Blood samples are collected regularly, initially every 14 days during early treatment cycles, then on the first day of each cycle as treatment progresses. Optional blood draws may occur alongside standard care labs when starting new therapies. Disease imaging and medical record reviews are performed throughout the study. Participants provide blood samples and undergo imaging to monitor disease status and treatment response. Blood draws occur frequently at first, then less often as the study continues until disease progression. The main outcome measured is the DiviTum®TKa assay as an early predictor of resistance to primary treatment, assessed approximately every 28 days for up to six months. The study includes detailed monitoring through medical record review and imaging, supporting long-term observation of treatment effects.
CONDITIONS
Brief Title
DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Pre- or post-menopausal women with hormone receptor-positive metastatic breast cancer
- Scheduled to initiate or currently receiving FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without endocrine therapy for metastatic breast cancer
- Scheduled to initiate or currently receiving FDA-approved endocrine therapy alone for metastatic breast cancer
- Scheduled to initiate or currently receiving first line CDK4/6 inhibitor with endocrine therapy for stage II or III adjuvant hormone receptor-positive breast cancer
- Patients already enrolled in another clinical trial may co-enroll in this observational study
You will not qualify if you...
- Treatment involving investigational agents or therapies
- Diagnosis of early breast cancer
- Male breast cancer patients
- Currently receiving treatment for another active malignancy except nonmelanoma skin cancer or carcinoma in-situ (e.g., cervix, prostate)
- Inability to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months or until disease progression
Participants undergo blood sample collection and disease imaging throughout the study while their medical records are reviewed. Blood draws occur periodically depending on treatment cycle and therapy line until disease progression.
Blood draws every 14 days during initial cycles, then on the first day of each treatment cycle; optional additional blood draws with standard care labs
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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