DiviTum Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients

Overview

About this study

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.   

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  •  
  • Females >18 years old.
  • 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+ 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 on-going 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: Non-melanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate).
  • Inability to give written informed consent.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/19/23. Questions regarding updates should be directed to the study team contact

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Pooja Advani, M.B.B.S., M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20566538

Mayo Clinic Footer