Breast Cancer
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
Description
The CDK4/6 Inhibitor Dosing Knowledge Study will study two CDK4/6 inhibitor dosing regimens in participants aged 65 or older with hormone receptor positive/HER2 negative (HR+/HER2-)metastatic breast cancer (MBC). The overarching goal of this pragmatic, randomized trial is to compare an “indicated” dosingapproach, as listed on the FDA-approved drug label, that starts at the full dose of a CDK4/6 inhibitor (palbociclib or ribociclib) incombination with dose reduction based on tolerability, versus a “titrated” dosing approach that starts at a lower dose of a CDK4/6 inhibitor and then titrates up to full dose as tolerated. CDK4/6 inhibitors will be given in combination with endocrine therapy (eitheran aromatase inhibitor (AI) or fulvestrant) based on the choice of the treating clinician.
Inclusion Notes
For a full description of this trial, please go to the listing on www.clinicaltrials.gov
Eligibility Criteria
Hormone receptor positive (HR+) HER2 negative metastatic breast cancer. Cut-off values for positive/negative staining should be as per standard practice in accordance with ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines. Verification of histology is preferred at the time of recurrence and where not possible or necessary in the judgment of the treating physician, the study will accept histology from the initial diagnosis.
Candidate for planned endocrine therapy in combination with 1st use of palbociclib or ribociclib, in the metastatic setting. The planned endocrine partner can be an aromatase inhibitor (letrozole, anastrozole, exemestane) or fulvestrant, selected through patient/provider choice.
Age 65 years or older.
Adequate bone marrow and organ function.
Absolute neutrophil count > 1,000/µL
Platelets > 100,000/µL
Hemoglobin > 9g/dL
Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (participants with documented Gilbert’s disease are allowed total bilirubin up to 5X ULN)
AST /ALT < 3 x institutional ULN, or ≤ 5 x ULN for subjects with documented metastatic disease to the liver
Creatinine < institutional ULN or creatinine clearance > 30 mL/min/1.73 m2 for subjects with creatinine levels above institutional ULN
Baseline QTc < 480 ms (only for ribociclib participants)
Ability to understand and the willingness to sign a written informed consent document.
Start Date
Tuesday, October 15, 2024
Principal / Contact Name
Dr. Leonard Henry