Assessing blood test for optimal CDK4/6 inhibitor levels in metastatic breast cancer
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
This study is testing a new blood test to see if it can help people with advanced hormone-positive breast cancer get the right amount of their medication to improve their treatment outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Yale University Academic / other |
| Locations | 18 sites (Derby, Connecticut and 17 other locations) |
| Trial ID | NCT06572800 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a blood test developed by DiviTum to identify optimal levels of CDK4/6 inhibitor medications in patients with metastatic hormone-positive breast cancer. The study aims to improve patient outcomes by counseling participants on medication compliance and adjusting for potential drug-drug interactions. Blood samples will be collected at various points during treatment to monitor CDK4/6 inhibitor response and correlate it with thymidine kinase activity levels. The trial will also compare clinical benefit rates and progression-free survival between patients with optimal and sub-optimal responses to treatment.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed metastatic ER-positive and HER2-negative breast cancer who are starting CDK4/6 inhibitor therapy.
Not a fit: Patients without evidence of metastatic disease or those who have previously received CDK4/6 inhibitors will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective personalized treatment strategies for patients with metastatic breast cancer.
How similar studies have performed: Other studies have shown promise in optimizing treatment through biomarker-guided approaches, making this a potentially impactful continuation of that research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must have histologically confirmed metastatic ER-positive (\> 10%), PR-positive or PR-negative, and HER2-negative (0 by immunohistochemistry \[IHC\] or if +1 or +2 by IHC, not amplified by fluorescence in situ hybridization \[FISH\]) breast cancer; ER positivity, PR positivity, and HER2 negativity as per the 2018 joint American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. * Participants must be starting CDK4/6 inhibitor and endocrine therapy as part of first-line therapy per standard of care and be previously CDK4/6 inhibitor-naïve. * Participants must be enrolled prior to starting CDK4/6 inhibitor therapy. * Participants must be ≥ 18 years of age. * Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3. * Willing and able to provide written informed consent for the trial. Exclusion Criteria: * Participants without evidence of metastatic disease prior to registration. * Participants with prior use of CDK4/6 inhibitor therapy. * Participants who are unable to provide informed consent for the trial.
Where this trial is running
Derby, Connecticut and 17 other locations
- Smilow Cancer Hospital-Derby Care Center — Derby, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital Care Center-Fairfield — Fairfield, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital Care Center at Glastonbury — Glastonbury, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital Care Center at Greenwich — Greenwich, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital Care Center - Guilford — Guilford, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital-Hamden Care Center — Hamden, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States (Recruiting)
- Smilow Cancer Center/Yale-New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
- Yale-New Haven Hospital Saint Raphael Campus — New Haven, Connecticut, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- Yale-New Haven Hospital North Haven Medical Center — North Haven, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital-Orange Care Center — Orange, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital Care Center at Long Ridge — Stamford, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital-Torrington Care Center — Torrington, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital-Waterbury Care Center — Waterbury, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut, United States (Recruiting)
- Smilow Cancer Hospital Care Center - Westerly — Westerly, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Mariya Rozenblit — Yale University
- Study coordinator: Nathalie Wiesendanger, MS
- Email: nathalie.wiesendanger@yale.edu
- Phone: 1 475 301 6980
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.