CDK4/6 Inhibitor Dosing for Metastatic Breast Cancer
This study, called the CDK Study, is for people aged 65 or older with hormone receptor-positive (HR+) and HER2-negative metastatic breast cancer. It's looking at different ways to give two common medicines, palbociclib and ribociclib, which are CDK4/6 inhibitors. One group will receive the standard dose, while another group will start with a lower dose and slowly increase it if they tolerate it well. The goal is to see if starting with a lower dose helps people stay on treatment longer and experience fewer side effects. The study plans to enroll 500 participants.
- Study design
- This is a randomized study comparing two dosing approaches for CDK4/6 inhibitors. It aims to enroll 500 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 48 months to track how long they stay on treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study
At a glance
Conditions
Where it's being run
73 sites across 17 statesStudy leadership
- Julie Gralow, MD · PRINCIPAL_INVESTIGATOR · American Society of Clinical Oncology
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Time to Treatment Discontinuation (TTD)up to 48 months
Our primary outcome is time to CDK4/6 inhibitor discontinuation (TTD): the number of days between randomization and the last day the patient takes any dose of the same CDK4/6 inhibitor (regardless of drug holds, dose changes