Tka Assay for CDK4/6i
Public ClinicalTrials.gov record NCT06572800. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Use of DiviTum-TKa as a Biomarker Assay for CDK4/6 Inhibitor Medication Compliance and Drug-Drug Interaction Assessment in ER/PR Positive Metastatic Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06572800
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 34 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 4, 2023
- Primary completion
- Sep 15, 2025
- Completion
- Sep 15, 2025
- Last update posted
- Oct 7, 2025
2023 – 2025
United States locations
- U.S. sites
- 18
- U.S. states
- 2
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Smilow Cancer Hospital-Derby Care Center | Derby | Connecticut | 06418 | — |
| Smilow Cancer Hospital Care Center-Fairfield | Fairfield | Connecticut | 06824 | — |
| Smilow Cancer Hospital Care Center at Glastonbury | Glastonbury | Connecticut | 06033 | — |
| Smilow Cancer Hospital Care Center at Greenwich | Greenwich | Connecticut | 06830 | — |
| Smilow Cancer Hospital Care Center - Guilford | Guilford | Connecticut | 06437 | — |
| Smilow Cancer Hospital-Hamden Care Center | Hamden | Connecticut | 06518 | — |
| Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | 06105 | — |
| Smilow Cancer Center/Yale-New Haven Hospital | New Haven | Connecticut | 06510 | — |
| Yale-New Haven Hospital Saint Raphael Campus | New Haven | Connecticut | 06511 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Yale-New Haven Hospital North Haven Medical Center | North Haven | Connecticut | 06473 | — |
| Smilow Cancer Hospital-Orange Care Center | Orange | Connecticut | 06477 | — |
| Smilow Cancer Hospital Care Center at Long Ridge | Stamford | Connecticut | 06902 | — |
| Smilow Cancer Hospital-Torrington Care Center | Torrington | Connecticut | 06790 | — |
| Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut | 06611 | — |
| Smilow Cancer Hospital-Waterbury Care Center | Waterbury | Connecticut | 06708 | — |
| Smilow Cancer Hospital Care Center - Waterford | Waterford | Connecticut | 06385 | — |
| Smilow Cancer Hospital Care Center - Westerly | Westerly | Rhode Island | 02891 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06572800, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 7, 2025 · Synced Sep 4, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06572800 live on ClinicalTrials.gov.