Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377852
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-08
Brief Title:
The CDK46 Inhibitor Dosing Knowledge CDK Study
Sponsor:
American Society of Clinical Oncology
Organization:
American Society of Clinical Oncology
Study Overview
Official Title:
Comparing Oral Drug Dosing Strategies in Older Patients with Metastatic Breast Cancer to Maximize Tolerance and Reduce Discontinuation the CDK46 Inhibitor Dosing Knowledge CDK Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to generate evidence on an alternative dosing strategy for CDK46 inhibitors to help more patients with Metastatic Breast Cancer MBC age 65 years tolerate side effects and stay on treatment longer to derive the most clinical benefit from these drugs
The primary objective of the CDK Study is to compare time to treatment discontinuation TTD on the approved dosing for palbociclib 125 mg orally daily on days 1-21 of 28-day cycle or ribociclib 600 mg orally daily on days 1-21 of 28-day cycle vs TTD using titrated dosing approach with the same schedule but starting at a lower dose of palbociclib 100 mg or 75 mg or ribociclib 400 mg or 200 mg and escalating the dose if well-tolerated in combination with providerpatient choice endocrine therapy aromatase inhibitor AI or fulvestrant in patients age 65 or older with HRHER2- MBC The secondary and exploratory objectives will generate evidence needed to personalize treatment decisions by comparing patient-centric secondary outcomes and evaluating baseline factors
Together with their treating physician participants will choose the CDK46 inhibitor palbociclib or ribociclib and which endocrine therapy aromatase inhibitor or fulvestrant of their choice but will be randomized to either Arm 1 indicated dosing or Arm 2 titrated dosing
The primary objective of the CDK Study is to compare time to treatment discontinuation TTD on the approved dosing for palbociclib 125 mg orally daily on days 1-21 of 28-day cycle or ribociclib 600 mg orally daily on days 1-21 of 28-day cycle vs TTD using titrated dosing approach with the same schedule but starting at a lower dose of palbociclib 100 mg or 75 mg or ribociclib 400 mg or 200 mg and escalating the dose if well-tolerated in combination with providerpatient choice endocrine therapy aromatase inhibitor AI or fulvestrant in patients age 65 or older with HRHER2- MBC The secondary and exploratory objectives will generate evidence needed to personalize treatment decisions by comparing patient-centric secondary outcomes and evaluating baseline factors
Together with their treating physician participants will choose the CDK46 inhibitor palbociclib or ribociclib and which endocrine therapy aromatase inhibitor or fulvestrant of their choice but will be randomized to either Arm 1 indicated dosing or Arm 2 titrated dosing
Detailed Description:
The CDK46 Inhibitor Dosing Knowledge Study CDK Study will study CDK46 inhibitor dosing regimens in patients 65 or older with Metastatic Breast Cancer MBC The overarching goal of this pragmatic randomized trial is to compare an indicated dosing approach as listed on the FDA-approved drug label that starts at the full dose of a CDK46 inhibitor palbociclib or ribociclib with dose reduction based on tolerability versus a titrated dosing approach that starts at a lower dose of a CDK46 inhibitor and then titrates up to full dose as tolerated CDK46 inhibitors will be given in combination with endocrine therapy either an aromatase inhibitor AI or fulvestrant based on the choice of the treating clinician
The primary endpoint will be time to treatment discontinuation TTD defined as the time from randomization to last dose of the CDK46 inhibitor The hypothesis is that starting low and escalating as tolerated will help older patients 65 years stay on therapy longer Eligibility criteria are broad to allow patients who are not typically included in clinical trials to participate allowing for a more representative sample of participants The investigators will conduct sub-group analyses based on age 65-74 years vs 75 years and baseline frailty scores This study builds upon the lessons learned from prior studies with CDK46 inhibitors The investigators will augment the standard assessment of treatment toxicities assessed by the health care team with prospectively collected patient-reported outcomes data to better reflect how participants tolerate the different dosing approaches
The primary endpoint will be time to treatment discontinuation TTD defined as the time from randomization to last dose of the CDK46 inhibitor The hypothesis is that starting low and escalating as tolerated will help older patients 65 years stay on therapy longer Eligibility criteria are broad to allow patients who are not typically included in clinical trials to participate allowing for a more representative sample of participants The investigators will conduct sub-group analyses based on age 65-74 years vs 75 years and baseline frailty scores This study builds upon the lessons learned from prior studies with CDK46 inhibitors The investigators will augment the standard assessment of treatment toxicities assessed by the health care team with prospectively collected patient-reported outcomes data to better reflect how participants tolerate the different dosing approaches
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None