RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-30

Study Completion:2026-06-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06388122

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Clinical Trials Referral Office

CONTACT

855-776-0015

mayocliniccancerstudies@mayo.edu

Principal Investigator

Pooja Advani, MBBS, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Pooja Advani, MBBS, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-30

Study Completion Date2026-06-15

Study Record Updates

Study Start Date2024-04-30

Study Completion Date2026-06-15

Terms related to this study

Additional Relevant MeSH Terms

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