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:

Patient-Centered Outcomes Research Institute - PCORI

Sponsor Study ID:

Pro00075309

CTO #:

104354

NCT Number:

NCT06377852

Phase:

III

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Breast

Study Objectives:

To compare the time to CDK4/6 inhibitor discontinuation when starting on the full FDA-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. the time to discontinuation when using a titrated dosing approach, using the same schedule but starting at a lower dose of palbociclib (75 mg or 100 mg) or ribociclib (200 mg or 400 mg) and escalating the dose if well-tolerated in participants aged 65 or older with HR+/HER2- metastatic breast cancer (MBC) without prior exposure to CDK4/6 inhibitors in the metastatic setting.

eConsent:

Not available

Study Documents:

Open Study Documents
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