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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
NCT04968964 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE DiviTum® TKa assay
- OTHER Study Care Plans
Study Locations (1)
Missouri
- Washington University School of Medicine — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2029-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04968964
The ClinicalTrials.gov registry entry for NCT04968964 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,036 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which DiviTum® TKa assay is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04968964 reports 1 study location spanning 1 distinct geographic area — top geographies include Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04968964 about?
NCT04968964 is a clinical study titled "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". 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 si...
What is the current status of trial NCT04968964?
This trial is currently recruiting. It is a NA study. The enrollment target is 55 participants. The study started on 2022-03-07. Estimated completion is 2029-09-30.
What conditions does trial NCT04968964 study?
This clinical trial studies the following conditions: Breast Cancer, Cancer of the Breast. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04968964?
The interventions under investigation include: DiviTum® TKa assay (DEVICE), Study Care Plans (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04968964?
This trial is sponsored by Washington University School of Medicine, which has 1,036 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04968964 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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