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DiviTum®TKa Biomarker Study for HR+ Breast Cancer

This observational study is looking at a biomarker test called DiviTum®TKa. The goal is to see if this test can predict early on whether treatment is working for people with hormone receptor-positive (HR+) and HER2-negative metastatic breast cancer. You might be able to join if you are a woman, age 18 or older, with HR+ metastatic breast cancer and are starting a combination of an FDA-approved CDK4/6 inhibitor (like palbociclib, ribociclib, or abemaciclib) and an endocrine therapy. The study aims to find a pattern in how this test relates to your response to these treatments. The study plans to enroll 100 participants, but its current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 100 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo blood sample collection. This would happen approximately every 28 days until disease progression, for up to 6 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured until disease progression, for up to 6 months.

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NCT06388122

DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~100 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Biospecimen Collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
DiviTum®TKa assay as an early predictor of primary treatment resistance
Measured over Every cycle (approximately 28 days) until disease progression up to 6 months

Conditions

HER2-negative Breast Cancer
Hormone-receptor-positive Breast Cancer
Metastatic Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
HER2 Negative Breast Carcinoma
Hormone Receptor Positive Breast Carcinoma
Metastatic Breast Carcinoma

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Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Pooja Advani, MBBS, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pre- or post-menopausal HR+ metastatic breast cancer patients who are:
Group 1: scheduled to initiate 1st line combination therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ metastatic breast cancer (mBC).
Group 2: scheduled to initiate second or later lines of therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.
Group 3: currently receiving 1st line therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.
Group 4: scheduled to initiate, or are currently receiving, 1st or 2nd line therapy of an FDA approved endocrine therapy (single agent) for pre- or post-menopausal HR+ mBC.
Group 5: scheduled to initiate or are currently receiving 1st line therapy of an FDA-approved CDK4/6 inhibitor (ribociclib or abemaciclib) with an FDA approved endocrine therapy for stage 2 or stage 3 adjuvant HR+ BC

Exclusion

Treatment including investigational agent or therapies
Early breast cancer diagnosis
Male breast cancer
Currently receiving treatment for other active malignancy at time of registration
EXCEPTIONS: Nonmelanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate)
Inability to give written informed consent

What this trial measures

  • DiviTum®TKa assay as an early predictor of primary treatment resistanceEvery cycle (approximately 28 days) until disease progression up to 6 months

    Blood samples collected from participants will be assessed using DiviTum®TKa assay for thymidine kinase activity (TKa) levels above Limit of Detection (LOD) as a predictor of primary treatment resistance. Primary treatment resistance will be defined as disease progression in less than 6 months.