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
Content last updated on December 11, 2023.
This study is not currently recruiting or enrolling participants.
About the CDK Study
The CDK Study will analyze different starting dose levels of CDK4/6 inhibitors, a type of targeted therapy, in patients 65 and older with hormone receptor (HR) positive/HER2 negative metastatic breast cancer.
This study will focus on two FDA-approved CDK4/6 inhibitors, palbociclib and ribociclib, in combination with standard endocrine therapy. Patients 65 years or older with HR-/HER2+ metastatic breast cancer will be randomized to either a “standard” group (Arm 1) or a “titrated” group (Arm 2). The standard group will start with the FDA approved full dose of the CDK4/6 inhibitor and decrease dosage if side effects occur. The titrated group will start with a lower dose and escalate if well-tolerated.
The primary objective will compare time to discontinuation for the two arms.
Interested Clinical Sites
More information will be posted in Spring 2024. Please note that this study is not currently recruiting or enrolling participants.
If your clinical site is interested in participating in the CDK Study, you can complete the Study Intake Form for Interested Sites now.
For more information about the study, please email us.
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