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

Description

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

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
HER2-negative Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224-9980

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Pooja Advani, MBBS, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2026-06-15