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

Recruiting

• Conditions: Metastatic Breast Cancer; HER2-negative Breast Cancer; Hormone-receptor-positive Breast Cancer

• Registration Number: NCT06388122
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to explore the clinical utility of routinely measuring thymidine kinase activity (TKa) in HR+ metastatic breast cancer patients receiving treatment with any approved endocrine therapy either alone or in combination with any approved CDK4/6 inhibitor.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-24
• Study First Submitted QC: 2024-04-26
• Study First Posted: 2024-04-29
• Study Start: 2024-04-30
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-03
• Last Update Posted: 2025-09-09
• Primary Completion: 2031-06-15
• Study Completion: 2031-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• 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.

NOTE: Patients that meet eligibility criteria for any of the above groups that are already enrolled in an ongoing clinical trial are eligible for co-enrollment to this observational study.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DiviTum®TKa assay as an early predictor of primary treatment resistance	Every 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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States