NCT06377852View on ClinicalTrials.gov

The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

PHASE3RecruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

October 29, 2024

Primary Completion Date

August 31, 2028

Study Completion Date

September 1, 2028

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Palbociclib 125mg

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

DRUG

Ribociclib 600mg

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

DRUG

Ribociclib

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.

DRUG

Palbociclib

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.

Trial Locations (63)

17601

RECRUITING

Penn Medicine - Lancaster General Hospital, Lancaster

19104

RECRUITING

Penn Medicine - Perelman Center for Advanced Medicine, Philadelphia

19106

RECRUITING

Penn Medicine - Pennsylvania Hospital, Philidelphia

19380

RECRUITING

Penn Medicine - Chester County Hospital, West Chester

28001

RECRUITING

Levine Cancer Institute, Albemarle

28025

RECRUITING

Levine Cancer Institute, Concord

28043

RECRUITING

Levine Cancer Institute, Forest City

28054

RECRUITING

Levine Cancer Institute, Gastonia

28078

RECRUITING

Levine Cancer Institute, Huntersville

28092

RECRUITING

Levine Cancer Institute, Lincolnton

28104

RECRUITING

Levine Cancer Institute, Matthews

28112

RECRUITING

Levine Cancer Institute, Monroe

28150

RECRUITING

Levine Cancer Institute, Shelby

28204

RECRUITING

Levine Cancer Institute, Charlotte

28210

RECRUITING

Levine Cancer Institute, Charlotte

28211

RECRUITING

Levine Cancer Institute, Charlotte

28262

RECRUITING

Levine Cancer Institute, Charlotte

28277

RECRUITING

Levine Cancer Institute, Charlotte

29732

RECRUITING

Levine Cancer Institute, Rock Hill

29910

RECRUITING

St. Joseph's Candler Bluffton Campus, Bluffton

29926

RECRUITING

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

30322

RECRUITING

Emory University Winship Cancer Institute, Atlanta

31405

RECRUITING

Lewis Cancer and Research Pavilion, Savannah

33176

RECRUITING

Miami Cancer Institute, Miami

33324

RECRUITING

Miami Cancer Institute, Plantation

38120

RECRUITING

Baptist Memorial Healthcare, Memphis

66205

RECRUITING

The University of Kansas Cancer Center, Westwood

80045

RECRUITING

University of Colorado Anschutz Medical Campus, Aurora

85028

RECRUITING

Ironwood Cancer & Research Centers, Phoenix

85202

RECRUITING

Ironwood Cancer & Research Centers, Mesa

85206

RECRUITING

Ironwood Cancer & Research Centers, Mesa

85224

RECRUITING

Ironwood Cancer & Research Centers, Chandler

85260

RECRUITING

Ironwood Cancer & Research Centers, Scottsdale

85297

RECRUITING

Ironwood Cancer & Research Centers, Gilbert

85306

RECRUITING

Ironwood Cancer & Research Centers, Glendale

87102

RECRUITING

Lovelace Medical Center - Saint Joseph Square, Albuquerque

87109

RECRUITING

Lovelace Women's Hospital, Albuquerque

87110

RECRUITING

Presbyterian Kaseman Hospital, Albuquerque

87124

RECRUITING

Presbyterian Rust Medical Center/Jorgensen Cancer Center, Rio Rancho

87131

RECRUITING

The University of New Mexico Comprehensive Cancer Center, Albuquerque

88011

RECRUITING

Memorial Medical Center, Las Cruces

06418

RECRUITING

Smilow Cancer Hospital Care Center - Derby, Derby

06824

RECRUITING

Smilow Cancer Hospital Care Center - Fairfield, Fairfield

06033

RECRUITING

Smilow Cancer Hospital at Glastonbury, Glastonbury

06830

RECRUITING

Smilow Cancer Hospital Care Center - Greenwich, Greenwich

06437

RECRUITING

Smilow Cancer Hospital Care Center - Guilford, Guilford

06105

RECRUITING

Smilow Cancer Hospital at Saint Francis, Hartford

06510

RECRUITING

Yale University/Yale Cancer Center, New Haven

06473

RECRUITING

Smilow Cancer Hospital Care Center - North Haven, North Haven

06790

RECRUITING

Smilow Cancer Hospital Care Center - Torrington, Torrington

06611

RECRUITING

Smilow Cancer Hospital Care Center - Trumbull, Trumbull

06708

RECRUITING

Smilow Cancer Hospital Care Center - Waterbury, Waterbury

06385

RECRUITING

Smilow Cancer Hospital - Waterford, Waterford

04330

RECRUITING

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

04412

RECRUITING

The Jackson Laboratory (JAX) - Northern Light Cancer Care, Brewer

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

02035

RECRUITING

Dana-Farber Brigham Cancer Center Foxborough, Foxborough

01844

RECRUITING

Dana-Farber Cancer Institute Merrimack Valley, Methuen

01757

RECRUITING

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

02190

RECRUITING

Dana-Farber Brigham Cancer Center at South Shore Health, Weymouth

03053

NOT_YET_RECRUITING

Dana-Farber/New Hampshire Oncology-Hematology, Londonderry

08536

RECRUITING

Penn Medicine - Princeton Health, Plainsboro

02891

RECRUITING

Smilow Cancer Hospital - Westerly, Westerly

All Listed Sponsors
collaborator

Patient-Centered Outcomes Research Institute

OTHER

lead

American Society of Clinical Oncology

OTHER