Phase 3Recruiting
The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study
Comparing Oral Drug Dosing Strategies in Older Patients With Metastatic Breast Cancer to Maximize Tolerance and Reduce Discontinuation: The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study
- Sponsor
- American Society of Clinical Oncology (Academic or other)
- Enrolment
- 500 planned
- Conditions
- Metastatic Breast Cancer
- Interventions
- Palbociclib 125mg; Ribociclib 600mg; Ribociclib; Palbociclib
- Ages
- adults, older adults
- Registry
- NCT06377852
Full record on ClinicalTrials.gov
From the registry
The purpose of this study is to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with Metastatic Breast Cancer (MBC) (age ≥ 60 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 provider/patient choice endocrine therapy (aromatase inhibitor (AI) or fulvestrant) in patients age 60 or older with HR+/HER2- 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…
Primary outcomes
- Time to Treatment Discontinuation (TTD)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered