MedTrace Logo

Tka Assay for CDK4/6i

NCT06572800 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-10-08

No results posted yet for this study

Summary

This clinical trial assesses whether using a test developed by DiviTum can identify optimal levels of CDK 4/6 inhibitor medications in the blood and whether assessing medical compliance and drug-drug interactions can optimize (improve) these levels in patients with estrogen receptor (ER) or progesterone receptor (PR) positive, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and are receiving CDK 4/6 inhibitors. CDK4/6 inhibitors in combination with endocrine therapy (ET) is first line treatment for metastatic hormone positive (ER/PR positive) breast cancer (mBC). Thymidine kinase is a biomarker (biological molecule found in blood, other body fluids, or tissues that is a sign of a condition or disease) that reflects cell proliferation (an increase in the number of cells as a result of cell growth and cell division). DiviTum-thymidine kinase activity (TKa) is a Food and Drug Administration approved assay which showed that a TKa is associated with the decreased likelihood of disease progression within 30 days or 60 days post testing. Using the DiviTum-TKa may improve medication compliance and remove potential drug-drug interactions in patients with ER/PR positive HER2-negative MBC.

Conditions

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Metastatic HER2-Negative Breast Carcinoma

Interventions

DEVICE

DiviTum-TKa

Analyze blood samples by DiviTum-TKa

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Mariya Rozenblit · Yale University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-05
Primary Completion
2025-09-16
Completion
2025-09-16
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06572800 on ClinicalTrials.gov