RecruitingNot ApplicableNCT04968964

Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing

TK IMPACT: Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing: Physician Decision Impact Study


Sponsor

Washington University School of Medicine

Enrollment

55 participants

Start Date

Mar 7, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging. Circulating tumor biomarkers are sometimes also incorporated. Frequent testing with numerous diagnostics at each time point is a significant burden to patients and to healthcare systems. The DiviTum® TKa assay measures TK1 activity. Numerous studies have illustrated the prognostic nature of plasma or serum TK1 activity level in metastatic cancer. The investigators hypothesize that the incorporation of data from DiviTum® TKa measurement into the treatment monitoring schema will be associated with physician desire to change the near-term usage and/or timing of other routine restaging tests, including either standard tumor imaging or tumor marker testing. Given the relatively low rate of disease progression in this first-line population, it is expected that most of this change will be an intended reduction in scheduling of routine treatment surveillance testing with increase in intervals of subsequent tumor restaging imaging by at least 4 weeks. Secondarily, the consequences of rescheduling of routine surveillance testing may ultimately result in an absolute reduction in the number of some tests used during the time period examined.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether adding a blood test called TK1 (thymidine kinase 1) — a marker of cancer cell activity — improves monitoring of treatment response in women with HR-positive, HER2-negative metastatic breast cancer receiving CDK4/6 inhibitor therapy. **You may be eligible if...** - You have been diagnosed with metastatic or advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative - You have had imaging done within the past 4 weeks - In the first group (Cohort 1): you are about to start your first-line treatment combining a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) with hormone therapy - In the second group (Cohort 2): you are starting a second-line CDK4/6 inhibitor regimen after prior progression **You may NOT be eligible if...** - Your breast cancer is HER2-positive - You do not have metastatic or advanced disease - You do not fit into either cohort's treatment timing requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDiviTum® TKa assay

-Determines serum enzymatic activity of TK1

OTHERStudy Care Plans

-Study Care Plans will be completed prior to and post release of serum DiviTum® TKa value


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT04968964


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