Tka Assay for CDK4/6i

Not Applicable

Recruiting

• Conditions: Anatomic Stage IV Breast Cancer AJCC v8; Metastatic HER2-Negative Breast Carcinoma

• Registration Number: NCT06572800
• Lead Sponsor: Yale University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Inclusion Criteria:<br><br> - Participants must have histologically confirmed metastatic ER-positive (> 10%),<br> PR-positive or PR-negative, and HER2-negative (0 by immunohistochemistry [IHC] or if<br> +1 or +2 by IHC, not amplified by fluorescence in situ hybridization [FISH]) breast<br> cancer; ER positivity, PR positivity, and HER2 negativity as per the 2018 joint<br> American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP)<br> guidelines.<br><br> - Participants must be starting CDK4/6 inhibitor and endocrine therapy as part of<br> first-line therapy per standard of care and be previously CDK4/6 inhibitor-naïve.<br><br> - Participants must be enrolled prior to starting CDK4/6 inhibitor therapy.<br><br> - Participants must be = 18 years of age.<br><br> - Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance<br> Status < 3.<br><br> - Willing and able to provide written informed consent for the trial.<br><br>Exclusion Criteria:<br><br> - Participants without evidence of metastatic disease prior to registration.<br><br> - Participants with prior use of CDK4/6 inhibitor therapy.<br><br> - Participants who are unable to provide informed consent for the trial.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with thymidine kinase activity (TKa) values that switch from profile 3 to profile 1 or 2 after medication compliance and drug-drug interaction assessment;Rate of improvement in CDK4/6 inhibitor response (i.e. moving from profile 3 to profiles 1 or 2)

Secondary Outcome Measures

Name	Time	Method
Clinical benefit rate (CBR) in patients with sub-optimal (profile 3) and optimal (profiles 1 and 2) CDK4/6 inhibitor response;Progression free survival (PFS);CDK4/6 inhibitor response via TKa levels upon CDK4/6 inhibitor dose reductions or changes in CDK4/6 inhibitor regimen due to adverse events;Comparison of CDK4/6 inhibitor response profiles across the three CDK 4/6 inhibitors