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The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

NCT06377852 · American Society of Clinical Oncology
In plain English

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Official title
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
About this study
The CDK4/6 Inhibitor Dosing Knowledge Study (CDK Study) will study CDK4/6 inhibitor dosing regimens in patients 60 or older with Metastatic Breast Cancer (MBC). The overarching goal of this pragmatic, randomized trial is to compare an "indicated" dosing approach, as listed on the FDA-approved drug label, that starts at the full dose of a CDK4/6 inhibitor (palbociclib or ribociclib) 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 (either an aromatase inhibitor (AI) or fulvestrant) based on the choice of the treating clinician. The primary endpoint will be time to treatment discontinuation (TTD), defined as the time from randomization to last dose of the CDK4/6 inhibitor. The hypothesis is that starting low and escalating as tolerated will help older patients (\> 60 years) stay on therapy longer. Eligibility criteria are broad to allow patients who are not typically included in clinical trials to participate, allowing for a more representative sample of participants. The investigators will conduct sub-group analyses based on age (60-64 years vs. 65-74 years vs. ≥75 years) and baseline frailty scores. This study builds upon the lessons learned from prior studies with CDK4/6 inhibitors. The investigators will augment the standard assessment of treatment toxicities assessed by the health care team with prospectively collected patient-reported outcomes data to better reflect how participants tolerate the different dosing approaches.
Eligibility criteria
Inclusion Criteria: 1. 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. 2. 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. 3. Aged 60 years or older 4. Adequate bone marrow and organ function. Laboratory values must be within normal institutional limits, or within ranges as indicated below, or demonstrate minor abnormalities that are deemed clinically non-significant by the investigator. * Absolute neutrophil count ≥ 1,000/µL * 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 (SGOT)/ALT (SGPT) \<3 x institutional ULN, or ≤ 5 x ULN for subjects with documented metastatic disease to the liver. 5. Baseline QTc ≤ 480 ms (only for ribociclib patients) 6. Ability to understand and the willingness to provide informed consent. Note: Remote consent is allowed per institutional guidelines. Exclusion Criteria: 1. Previous treatment with a CDK4/6 inhibitor for metastatic breast cancer, or previous treatment within the past 12 months with a CDK4/6 inhibitor in the neo/adjuvant breast cancer setting. 2. Received greater than 60 days (in the metastatic setting) of the specific endocrine therapy agent planned as partner to the CDK4/6 inhibitor in the study at the time of randomization. 3. Known history of intolerance or allergy to the planned agents used in this trial. 4. Uncontrolled intercurrent illness that, as evaluated by the treating clinician, would hinder compliance with study requirements. 5. Concurrent therapy with other investigational agents or anticancer therapy beyond aromatase inhibitors or fulvestrant. Note: radiation is allowed at any time. 6. Rapidly progressive brain metastases. Note: only applies to patients with known brain metastases. Brain imaging not required for enrollment. 7. Active or chronic Hepatitis B or C are eligible provided they meet liver function laboratory criteria and are not on medication with a known interaction with the study agents. 8. Current use of drugs that have known potential to prolong the QT interval (e.g., antiarrhythmic drugs), for patients on ribociclib. Note: If concomitant use cannot be avoided, monitor ECG when initiating, during concomitant use, and as clinically indicated. Refer to crediblemeds.org as a resource. 9. Prior or concurrent malignancies that are undergoing active treatment.
Study design
Enrollment target: 500 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-10-29
Estimated completion: 2028-09-01
Last updated: 2026-09-04
Interventions
Drug: Palbociclib 125mgDrug: Ribociclib 600mgDrug: RibociclibDrug: Palbociclib
Primary outcomes
  • Time to Treatment Discontinuation (TTD) (up to 48 months)
Sponsor
American Society of Clinical Oncology · other
With: Patient-Centered Outcomes Research Institute
Contacts & investigators
ContactJackie Perez, MPH · contact · CDKstudy@asco.org · 571-483-1300
ContactCindy MacInnis, MBA · contact · CDKstudy@asco.org
InvestigatorJulie Gralow, MD · principal_investigator, American Society of Clinical Oncology
All locations (73)
Ironwood Cancer & Research CentersRecruiting
Chandler, Arizona, United States
Ironwood Cancer & Research CentersRecruiting
Gilbert, Arizona, United States
Ironwood Cancer & Research CentersRecruiting
Glendale, Arizona, United States
Ironwood Cancer & Research CentersRecruiting
Goodyear, Arizona, United States
Ironwood Cancer & Research CentersRecruiting
Mesa, Arizona, United States
Ironwood Cancer & Research CentersRecruiting
Mesa, Arizona, United States
Ironwood Cancer & Research CentersRecruiting
Phoenix, Arizona, United States
Ironwood Cancer & Research CentersRecruiting
Scottsdale, Arizona, United States
University of Colorado Anschutz Medical CampusRecruiting
Aurora, Colorado, United States
UCHealth Cherry Creek Medical CenterRecruiting
Denver, Colorado, United States
UCHealth Highlands Ranch HospitalRecruiting
Highlands Ranch, Colorado, United States
Smilow Cancer Hospital Care Center - DerbyRecruiting
Derby, Connecticut, United States
Smilow Cancer Hospital Care Center - FairfieldRecruiting
Fairfield, Connecticut, United States
Smilow Cancer Hospital at GlastonburyRecruiting
Glastonbury, Connecticut, United States
Smilow Cancer Hospital Care Center - GreenwichRecruiting
Greenwich, Connecticut, United States
Smilow Cancer Hospital Care Center - GuilfordRecruiting
Guilford, Connecticut, United States
Smilow Cancer Hospital at Saint FrancisRecruiting
Hartford, Connecticut, United States
Smilow Cancer Hospital - Yale New Haven HealthRecruiting
New Haven, Connecticut, United States
Yale University/Yale Cancer Center/Yale School of MedicineRecruiting
New Haven, Connecticut, United States
Smilow Cancer Hospital Care Center - North HavenRecruiting
North Haven, Connecticut, United States
Smilow Cancer Hospital Care Center - TorringtonRecruiting
Torrington, Connecticut, United States
Smilow Cancer Hospital Care Center - TrumbullRecruiting
Trumbull, Connecticut, United States
Smilow Cancer Hospital Care Center - WaterburyRecruiting
Waterbury, Connecticut, United States
Smilow Cancer Hospital - WaterfordRecruiting
Waterford, Connecticut, United States
Miami Cancer InstituteRecruiting
Miami, Florida, United States
Miami Cancer InstituteRecruiting
Plantation, Florida, United States
Emory University Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
Lewis Cancer and Research PavilionRecruiting
Savannah, Georgia, United States
The University of Kansas Cancer CenterRecruiting
Westwood, Kansas, United States
The Jackson Laboratory (JAX) - Harold Alfond Center for Cancer CareRecruiting
Augusta, Maine, United States
The Jackson Laboratory (JAX) - Northern Light Cancer CareRecruiting
Brewer, Maine, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Dana-Farber Brigham Cancer Center FoxboroughRecruiting
Foxborough, Massachusetts, United States
Dana-Farber Cancer Institute Merrimack ValleyRecruiting
Methuen, Massachusetts, United States
Dana-Farber Brigham Cancer Center at Milford Regional Medical CenterRecruiting
Milford, Massachusetts, United States
Dana-Farber Brigham Cancer Center at South Shore HealthRecruiting
Weymouth, Massachusetts, United States
Dana-Farber/New Hampshire Oncology-HematologyRecruiting
Londonderry, New Hampshire, United States
Penn Medicine - Princeton HealthRecruiting
Plainsboro, New Jersey, United States
Lovelace Medical Center - Saint Joseph SquareRecruiting
Albuquerque, New Mexico, United States
Lovelace Women's HospitalRecruiting
Albuquerque, New Mexico, United States
Presbyterian Kaseman HospitalRecruiting
Albuquerque, New Mexico, United States
The University of New Mexico Comprehensive Cancer CenterRecruiting
Albuquerque, New Mexico, United States
Memorial Medical CenterRecruiting
Las Cruces, New Mexico, United States
Presbyterian Rust Medical Center/Jorgensen Cancer CenterRecruiting
Rio Rancho, New Mexico, United States
Levine Cancer InstituteRecruiting
Albemarle, North Carolina, United States
Levine Cancer InstituteRecruiting
Charlotte, North Carolina, United States
Levine Cancer InstituteRecruiting
Charlotte, North Carolina, United States
Levine Cancer InstituteRecruiting
Charlotte, North Carolina, United States
Levine Cancer InstituteRecruiting
Charlotte, North Carolina, United States
Levine Cancer InstituteRecruiting
Charlotte, North Carolina, United States
Levine Cancer InstituteRecruiting
Concord, North Carolina, United States
Levine Cancer InstituteRecruiting
Forest City, North Carolina, United States
Levine Cancer InstituteRecruiting
Gastonia, North Carolina, United States
Levine Cancer InstituteRecruiting
Huntersville, North Carolina, United States
Levine Cancer InstituteRecruiting
Lincolnton, North Carolina, United States
Levine Cancer InstituteRecruiting
Matthews, North Carolina, United States
Levine Cancer InstituteRecruiting
Monroe, North Carolina, United States
Levine Cancer InstituteRecruiting
Shelby, North Carolina, United States
Penn Medicine - Lancaster General HospitalRecruiting
Lancaster, Pennsylvania, United States
Penn Medicine - Perelman Center for Advanced MedicineRecruiting
Philadelphia, Pennsylvania, United States
Penn Medicine - Pennsylvania HospitalRecruiting
Philidelphia, Pennsylvania, United States
Penn Medicine - Chester County HospitalRecruiting
West Chester, Pennsylvania, United States
Smilow Cancer Hospital - WesterlyRecruiting
Westerly, Rhode Island, United States
St. Joseph's Candler Bluffton CampusRecruiting
Bluffton, South Carolina, United States
SC Cancer Specialists - Hilton Head at St. Joseph's/CandlerRecruiting
Hilton Head Island, South Carolina, United States
Levine Cancer InstituteRecruiting
Rock Hill, South Carolina, United States
Baptist Memorial HealthcareRecruiting
Memphis, Tennessee, United States
Northwest Medical SpecialtiesRecruiting
Bonney Lake, Washington, United States
Northwest Medical SpecialtiesRecruiting
Federal Way, Washington, United States
Northwest Medical SpecialtiesRecruiting
Gig Harbor, Washington, United States
Northwest Medical SpecialtiesRecruiting
Olympia, Washington, United States
Northwest Medical SpecialtiesRecruiting
Puyallup, Washington, United States
Northwest Medical SpecialtiesRecruiting
Tacoma, Washington, United States