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

NCT06388122 | Recruiting

• 3 other identifiers: 23-009689NCI-2024-03405MC240301
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hormone-receptor-positive Breast Cancer; Metastatic Breast Cancer; HER2-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• DiviTum®TKa assay as an early predictor of primary treatment resistance

  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.

  Every cycle (approximately 28 days) until disease progression up to 6 months

Study Arms (4)

Group 1 (initiating 1st line CDK4/6 & endocrine therapy)

Blood will be drawn every 14 days starting from the first treatment cycle until the start of cycle 3; starting at cycle 3 blood will be drawn the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.

Procedure: Biospecimen Collection

Group 2 (initiating 2nd or later line of CDK4/6 with or without endocrine therapy)

Blood will be drawn every 14 days starting from the first treatment cycle until the start of cycle 3; starting at cycle 3 blood will be drawn the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.

Procedure: Biospecimen Collection

Group 3 (currently receiving 1st line CDK4/6 and endocrine therapy)

Blood will be drawn on day 15 of the next cycle after enrollment and the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.

Procedure: Biospecimen Collection

Group 4 (initiating or currently receiving 1st or 2nd line endocrine therapy)

Blood will be drawn at baseline or the first day of the treatment cycle and the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.

Procedure: Biospecimen Collection

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Group 1 (initiating 1st line CDK4/6 & endocrine therapy); Group 2 (initiating 2nd or later line of CDK4/6 with or without endocrine therapy); Group 3 (currently receiving 1st line CDK4/6 and endocrine therapy); Group 4 (initiating or currently receiving 1st or 2nd line endocrine therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult female patients \> 18 years old with diagnosis of metastatic HR positive HER2 negative breast cancer that will be or are currently being treated with standard of care endocrine therapy +/- CDK 4/6 inhibitors.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Pooja Advani, MBBS, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: April 30, 2024
• Primary Completion (Estimated): June 15, 2031
• Study Completion (Estimated): June 15, 2031
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1)