Trial Title:
Tka Assay for CDK4/6i
NCT ID:
NCT06572800
Condition:
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic HER2-Negative Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
DiviTum-TKa
Description:
Analyze blood samples by DiviTum-TKa
Arm group label:
Health services research (DiviTum-TKa)
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 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.
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 adjustment of potential deleterious drug-drug interactions.
SECONDARY OBJECTIVES:
I. Estimate the rate of sub-optimal CDK 4/6 inhibitor response (profile 3) in patients
with metastatic hormone positive breast cancer in cycle 1 of CDK4/6 inhibitor and
endocrine therapy in the first line setting.
II. Compare clinical benefit rate (CBR) in patients with sub-optimal (profile 3) and
optimal (profiles 1 and 2) CDK4/6 inhibitor response after both cycles 1 and cycle 3.
III. Compare progression free survival (PFS) rates at 6 months (mo), 12 mo, 18 mo in
patients with sub-optimal (profile 3) and optimal (profiles 1 and 2) CDK 4/6 inhibitor
response after both cycles 1 and cycle 3.
IV. Assess CDK4/6 inhibitor response via TKa levels upon CDK4/6 inhibitor dose reductions
or changes in CDK4/6 inhibitor regimens.
V. Compare CDK4/6 inhibitor response profiles across the three CDK 4/6 inhibitors among
different patients and within the same patients if CDK4/6 inhibitor is changed throughout
treatment course.
VI. Correlate TKa levels with tumor marker levels. VII. Assess plasma concentrations of
CDK4/6 inhibitor drugs in patients with suboptimal TKa levels.
OUTLINE:
Patients undergo collection of blood samples per standard of care (SOC) on days 1, 15,
and 28 of cycle 1, days 15 and 28 of cycle 2, days 15 and 28 of cycle 3, and day 28 of
subsequent cycles for up to 12 cycles for analysis by DiviTum-TKa in the absence of
disease progression or unacceptable toxicity.
After completion of study intervention, patients are followed up for 2 years.
Criteria for eligibility:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Smilow Cancer Hospital-Derby Care Center
Address:
City:
Derby
Zip:
06418
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Smilow Cancer Hospital Care Center-Fairfield
Address:
City:
Fairfield
Zip:
06824
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Smilow Cancer Hospital Care Center at Glastonbury
Address:
City:
Glastonbury
Zip:
06033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Smilow Cancer Hospital Care Center at Greenwich
Address:
City:
Greenwich
Zip:
06830
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Smilow Cancer Hospital Care Center - Guilford
Address:
City:
Guilford
Zip:
06437
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Smilow Cancer Hospital-Hamden Care Center
Address:
City:
Hamden
Zip:
06518
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Smilow Cancer Hospital Care Center at Saint Francis
Address:
City:
Hartford
Zip:
06105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Smilow Cancer Center/Yale-New Haven Hospital
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Yale-New Haven Hospital Saint Raphael Campus
Address:
City:
New Haven
Zip:
06511
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Yale University
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Yale-New Haven Hospital North Haven Medical Center
Address:
City:
North Haven
Zip:
06473
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Smilow Cancer Hospital-Orange Care Center
Address:
City:
Orange
Zip:
06477
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Smilow Cancer Hospital Care Center at Long Ridge
Address:
City:
Stamford
Zip:
06902
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Smilow Cancer Hospital-Torrington Care Center
Address:
City:
Torrington
Zip:
06790
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Smilow Cancer Hospital Care Center-Trumbull
Address:
City:
Trumbull
Zip:
06611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Smilow Cancer Hospital-Waterbury Care Center
Address:
City:
Waterbury
Zip:
06708
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Smilow Cancer Hospital Care Center - Waterford
Address:
City:
Waterford
Zip:
06385
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Facility:
Name:
Smilow Cancer Hospital Care Center - Westerly
Address:
City:
Westerly
Zip:
02891
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariya Rozenblit
Phone:
347-574-4420
Email:
Mariya.Rozenblit@yale.edu
Investigator:
Last name:
Mariya Rozenblit
Email:
Principal Investigator
Start date:
September 5, 2023
Completion date:
May 3, 2027
Lead sponsor:
Agency:
Yale University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Yale University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06572800
