Status:
COMPLETED
Tka Assay for CDK4/6i
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic HER2-Negative Breast Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
PRIMARY OBJECTIVE: I. To estimate the rate of improvement in CDK4/6 inhibitor response (i.e. moving from profile 3 to profiles 1 or 2) in cycles 2 and 3 after counseling for medication compliance and...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06572800
Start Date
September 5 2023
End Date
September 16 2025
Last Update
October 8 2025
Active Locations (18)
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1
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States, 06418
2
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States, 06824
3
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, United States, 06033
4
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States, 06830