Back to Clinical Trials
Phase 3Recruiting

The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

Sponsored by American Society of Clinical Oncology

About this study

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 ≥ 60 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 60 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.

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),…

Where this study is enrolling (68)

Show all 68 locations

  • Ironwood Cancer & Research Centers

    Phoenix, Arizona

    I'm interested

  • Ironwood Cancer & Research Centers

    Mesa, Arizona

    I'm interested

  • UCHealth Cherry Creek Medical Center

    Denver, Colorado

    I'm interested

  • UCHealth Highlands Ranch Hospital

    Highlands Ranch, Colorado

    I'm interested

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado

    I'm interested

  • Smilow Cancer Hospital at Saint Francis

    Hartford, Connecticut

    I'm interested

  • Yale University/Yale Cancer Center/Yale School of Medicine

    New Haven, Connecticut

    I'm interested

  • Smilow Cancer Hospital - Yale New Haven Health

    New Haven, Connecticut

    I'm interested

  • Smilow Cancer Hospital - Waterford

    Waterford, Connecticut

    I'm interested

  • Smilow Cancer Hospital Care Center - Waterbury

    Waterbury, Connecticut

    I'm interested

  • Smilow Cancer Hospital Care Center - Trumbull

    Trumbull, Connecticut

    I'm interested

  • Smilow Cancer Hospital Care Center - Torrington

    Torrington, Connecticut

    I'm interested

  • Smilow Cancer Hospital Care Center - North Haven

    North Haven, Connecticut

    I'm interested

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut

    I'm interested

  • Smilow Cancer Hospital Care Center - Greenwich

    Greenwich, Connecticut

    I'm interested

  • Smilow Cancer Hospital Care Center - Fairfield

    Fairfield, Connecticut

    I'm interested

  • Smilow Cancer Hospital Care Center - Derby

    Derby, Connecticut

    I'm interested

  • Smilow Cancer Hospital at Glastonbury

    Glastonbury, Connecticut

    I'm interested

  • Miami Cancer Institute

    Miami, Florida

    I'm interested

  • Miami Cancer Institute

    Plantation, Florida

    I'm interested

  • Lewis Cancer and Research Pavilion

    Savannah, Georgia

    I'm interested

  • Emory University Winship Cancer Institute

    Atlanta, Georgia

    I'm interested

  • The University of Kansas Cancer Center

    Westwood, Kansas

    I'm interested

  • The Jackson Laboratory (JAX) - Northern Light Cancer Care

    Brewer, Maine

    I'm interested

  • The Jackson Laboratory (JAX) - Harold Alfond Center for Cancer Care

    Augusta, Maine

    I'm interested

  • Dana-Farber Brigham Cancer Center at South Shore Health

    Weymouth, Massachusetts

    Call 8773387425

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Dana-Farber Brigham Cancer Center at Milford Regional Medical Center

    Milford, Massachusetts

    Call 8773387425

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Dana-Farber Cancer Institute Merrimack Valley

    Methuen, Massachusetts

    Call 877-338-7425

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Dana-Farber Cancer Institute

    Boston, Massachusetts

    Call 877-338-7425

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Dana-Farber Brigham Cancer Center Foxborough

    Foxborough, Massachusetts

    Call 877-338-7425

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Dana-Farber/New Hampshire Oncology-Hematology

    Londonderry, New Hampshire

    Call 877-338-7425

    This research site can be reached directly by phone. Call to ask about this study.

    Create a free account to get updates on similar Clinical Trials for your conditions.

  • Penn Medicine - Princeton Health

    Plainsboro, New Jersey

    I'm interested

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico

    I'm interested

  • The University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico

    I'm interested

  • Lovelace Medical Center - Saint Joseph Square

    Albuquerque, New Mexico

    I'm interested

  • Lovelace Women's Hospital

    Albuquerque, New Mexico

    I'm interested

  • Memorial Medical Center

    Las Cruces, New Mexico

    I'm interested

  • Presbyterian Rust Medical Center/Jorgensen Cancer Center

    Rio Rancho, New Mexico

    I'm interested

  • Levine Cancer Institute

    Albemarle, North Carolina

    I'm interested

  • Levine Cancer Institute

    Shelby, North Carolina

    I'm interested

  • Levine Cancer Institute

    Monroe, North Carolina

    I'm interested

  • Levine Cancer Institute

    Matthews, North Carolina

    I'm interested

  • Levine Cancer Institute

    Lincolnton, North Carolina

    I'm interested

  • Levine Cancer Institute

    Huntersville, North Carolina

    I'm interested

  • Levine Cancer Institute

    Gastonia, North Carolina

    I'm interested

  • Levine Cancer Institute

    Forest City, North Carolina

    I'm interested

  • Levine Cancer Institute

    Concord, North Carolina

    I'm interested

  • Levine Cancer Institute

    Charlotte, North Carolina

    I'm interested

  • Penn Medicine - Lancaster General Hospital

    Lancaster, Pennsylvania

    I'm interested

  • Penn Medicine - Chester County Hospital

    West Chester, Pennsylvania

    I'm interested

  • Penn Medicine - Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania

    I'm interested

  • Penn Medicine - Pennsylvania Hospital

    Philidelphia, Pennsylvania

    I'm interested

  • Smilow Cancer Hospital - Westerly

    Westerly, Rhode Island

    I'm interested

  • SC Cancer Specialists - Hilton Head at St. Joseph's/Candler

    Hilton Head Island, South Carolina

    I'm interested

  • St. Joseph's Candler Bluffton Campus

    Bluffton, South Carolina

    I'm interested

  • Levine Cancer Institute

    Rock Hill, South Carolina

    I'm interested

  • Baptist Memorial Healthcare

    Memphis, Tennessee

    I'm interested

  • Northwest Medical Specialties

    Federal Way, Washington

    I'm interested

  • Northwest Medical Specialties

    Tacoma, Washington

    I'm interested

  • Northwest Medical Specialties

    Bonney Lake, Washington

    I'm interested

  • Northwest Medical Specialties

    Puyallup, Washington

    I'm interested

  • Northwest Medical Specialties

    Olympia, Washington

    I'm interested

  • Northwest Medical Specialties

    Gig Harbor, Washington

    I'm interested
Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.