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NCT06388122 · ClinicalTrials.gov registry record
DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients
A clinical trial of Metastatic Breast Cancer and HER2-Negative Breast Cancer, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT06388122: Recruiting study of Metastatic Breast Cancer and HER2-Negative Breast Cancer, sponsored by Mayo Clinic.
NCT06388122 is a study of Metastatic Breast Cancer and HER2-Negative Breast Cancer that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 100 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06388122, a study of Metastatic Breast Cancer and HER2-Negative Breast Cancer, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Blood samples collected from participants will be assessed using DiviTum®TKa assay for thymidine kinase activity (TKa) levels above Limit of Detection (LOD) as a predictor of primary treatment resistance. Primary treatment resistance will be defined as disease progression in less than 6 months.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
Study Locations (1)
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-04-30 |
| Est. Completion | 2031-06-15 |
What NCT06388122 shows while recruiting
NCT06388122 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (51% lower).
The record links to 3 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Biospecimen Collection is the first listed.
NCT06388122 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06388122 about?
NCT06388122 is a clinical study titled "DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients". 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.
What is the current status of trial NCT06388122?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2024-04-30. Estimated completion is 2031-06-15.
What conditions does trial NCT06388122 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, HER2-Negative Breast Cancer, Hormone Receptor-Positive Breast Cancer.
What interventions are being tested in trial NCT06388122?
The interventions under investigation include: Biospecimen Collection (PROCEDURE).
Who is sponsoring clinical trial NCT06388122?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06388122 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06388122's enrollment target sits among peer trials
100 61st of 139 higher than 78 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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