The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

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 bu

Trial Details

NCT ID
NCT06377852
Phase
PHASE3
Sponsor
American Society of Clinical Oncology
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Palbociclib 125mg
  • Ribociclib 600mg
  • Ribociclib
  • Palbociclib
Locations (sample)
  • Chandler, Arizona, United States|33.30616,-111.84125
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Glendale, Arizona, United States|33.53865,-112.18599
  • Goodyear, Arizona, United States|33.43532,-112.35821
  • Mesa, Arizona, United States|33.42227,-111.82264

Key Eligibility Criteria

  • Hormone receptor positive (HR+) HER2 negative metastatic breast cancer. Cut-off values for positive/negative staining should be as per standard pra…
  • Candidate for planned endocrine therapy in combination with 1st use of palbociclib or ribociclib, in the metastatic setting. The planned endocrine …
  • Aged 60 years or older
  • Adequate bone marrow and organ function. Laboratory values must be within normal institutional limits, or within ranges as indicated below, or demo…

For full eligibility, visit ClinicalTrials.gov.

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