RecruitingPhase 3NCT06377852

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

Enrollment

500 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast Cancer

Summary

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 ≥ 65 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 65 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 treating physician, participants will choose the CDK4/6 inhibitor (palbociclib or ribociclib) and which endocrine therapy (aromatase inhibitor or fulvestrant) of their choice but will be randomized to either Arm 1 (indicated dosing) or Arm 2 (titrated dosing). Note: Telehealth visits are allowed at any time per institutional guidelines. In addition, the study allows for remote consenting per institutional guidelines.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how to optimize dosing of CDK4/6 inhibitors (targeted cancer drugs like palbociclib or ribociclib) in older patients with metastatic breast cancer, to find the safest and most effective dose based on individual patient factors. **You may be eligible if...** - You are 65 years or older - You have hormone receptor-positive (HR+), HER2-negative metastatic breast cancer - You are planning to start palbociclib or ribociclib for the first time in the metastatic setting, combined with a hormone-blocking therapy (an aromatase inhibitor or fulvestrant) **You may NOT be eligible if...** - You are under 65 - You have HER2-positive breast cancer - You have already received a CDK4/6 inhibitor for your metastatic disease - You are not a candidate for endocrine combination therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPalbociclib 125mg

Arm 1: Indicated dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle)

DRUGRibociclib 600mg

Arm 1: Indicated dosing of ribociclib (600 mg orally daily on days 1-21 of 28-day cycle)

DRUGRibociclib

Arm 2: Titrated dosing approach with the same schedule but starting at a lower dose of ribociclib (400 mg or 200 mg) and escalating the dose if well-tolerated in combination with provider/patient choice of endocrine therapy.

DRUGPalbociclib

Arm 2: Titrated dosing approach with the same schedule but starting at a lower dose of palbociclib (100 mg or 75 mg) and escalating the dose if well-tolerated in combination with provider/patient choice of endocrine therapy.