Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572800
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Tka Assay for CDK46i
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use of DiviTum-TKa as a Biomarker Assay for CDK46 Inhibitor Medication Compliance and Drug-Drug Interaction Assessment in ERPR Positive Metastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial assesses whether using a test developed by DiviTum can identify optimal levels of CDK 46 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 46 inhibitors CDK46 inhibitors in combination with endocrine therapy ET is first line treatment for metastatic hormone positive ERPR 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 ERPR positive HER2-negative MBC
Detailed Description:
PRIMARY OBJECTIVE
I To estimate the rate of improvement in CDK46 inhibitor response ie 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 46 inhibitor response profile 3 in patients with metastatic hormone positive breast cancer in cycle 1 of CDK46 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 CDK46 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 46 inhibitor response after both cycles 1 and cycle 3
IV Assess CDK46 inhibitor response via TKa levels upon CDK46 inhibitor dose reductions or changes in CDK46 inhibitor regimens
V Compare CDK46 inhibitor response profiles across the three CDK 46 inhibitors among different patients and within the same patients if CDK46 inhibitor is changed throughout treatment course
VI Correlate TKa levels with tumor marker levels VII Assess plasma concentrations of CDK46 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
I To estimate the rate of improvement in CDK46 inhibitor response ie 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 46 inhibitor response profile 3 in patients with metastatic hormone positive breast cancer in cycle 1 of CDK46 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 CDK46 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 46 inhibitor response after both cycles 1 and cycle 3
IV Assess CDK46 inhibitor response via TKa levels upon CDK46 inhibitor dose reductions or changes in CDK46 inhibitor regimens
V Compare CDK46 inhibitor response profiles across the three CDK 46 inhibitors among different patients and within the same patients if CDK46 inhibitor is changed throughout treatment course
VI Correlate TKa levels with tumor marker levels VII Assess plasma concentrations of CDK46 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None