Recruiting
Phase 3

CDK4/6 Inhibitor

Sponsor:

American Society of Clinical Oncology

Code:

NCT06377852

Conditions

Metastatic Breast Cancer

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Palbociclib 125mg

Ribociclib 600mg

Ribociclib

Palbociclib

Study Details

Brief 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 ≥ 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.

Conditions

Metastatic Breast Cancer

Study ID

NCT06377852

Start date

Oct 29, 2024

Status verified date

Sep, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: Indicated Dose

Arm 1 of the study is the indicated dosing regimen, provided in the FDA approved drug label: participants will start cycle 1 with either 125mg dose of palbociclib or 600mg dose of ribociclib, in combination with endocrine therapy (AI or fulvestrant).

experimental: Arm 2: Titrated Dose

Arm 2 is the titrated dosing regimen: participants will start cycle 1 with either 100 mg or 75 mg dose of palbociclib or 400 mg or 200 mg dose of ribociclib, in combination with endocrine therapy (AI or fulvestrant). For cycle 2 and for subsequent cycles, escalation to the indicated dose will be based on treatment tolerance.

Interventions

Palbociclib 125mg

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

Ribociclib 600mg

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

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.

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.

Primary outcome measure

  • Time to Treatment Discontinuation (TTD) [ Time Frame: up to 48 months ]

Central Contacts and Locations

Central contacts

Jackie Perez, MPH

571-483-1300CDKstudy@asco.org

Cindy MacInnis, MBA

CDKstudy@asco.org

Locations

Ironwood Cancer & Research Centers

Recruiting

Chandler, Arizona, United States, 85224

Contacts

Berenice Valdez

480-890-7705berenice.mendez@ironwoodcrc.com

Principal Investigator:

Sumeet Mendonca, MD

Ironwood Cancer & Research Centers

Recruiting

Gilbert, Arizona, United States, 85297

Contacts

Berenice Valdez

480-890-7705berenice.mendez@ironwoodcrc.com

Principal Investigator:

Sumeet Mendonca, MD

Ironwood Cancer & Research Centers

Recruiting

Glendale, Arizona, United States, 85306

Contacts

Berenice Valdez

480-890-7705berenice.mendez@ironwoodcrc.com

Principal Investigator:

Sumeet Mendonca, MD

Ironwood Cancer & Research Centers

Recruiting

Goodyear, Arizona, United States, 85395

Contacts

Berenice Valdez

480-890-7705berenice.mendez@ironwoodcrc.com

Principal Investigator:

Sumeet Mendonca, MD

Ironwood Cancer & Research Centers

Recruiting

Mesa, Arizona, United States, 85202

Contacts

Berenice Valdez

480-890-7705berenice.mendez@ironwoodcrc.com

Principal Investigator:

Sumeet Mendonca, MD

Ironwood Cancer & Research Centers

Recruiting

Mesa, Arizona, United States, 85206

Contacts

Berenice Valdez

480-890-7705berenice.mendez@ironwoodcrc.com

Principal Investigator:

Sumeet Mendonca, MD

Ironwood Cancer & Research Centers

Recruiting

Phoenix, Arizona, United States, 85028

Contacts

Berenice Valdez

480-890-7705berenice.mendez@ironwoodcrc.com

Principal Investigator:

Sumeet Mendonca, MD

Ironwood Cancer & Research Centers

Recruiting

Scottsdale, Arizona, United States, 85260

Contacts

Berenice Valdez

480-890-7705berenice.mendez@ironwoodcrc.com

Principal Investigator:

Sumeet Mendonca, MD

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Anna Lampart

303-724-6231anna.lamport@cuanschutz.edu

Enrique Soto, MD

303-724-6231enrique.2.soto@cuanschutz.edu

Principal Investigator:

Enrique Soto, MD

UCHealth Cherry Creek Medical Center

Recruiting

Denver, Colorado, United States, 80206

Contacts

Anna Lamport

303-724-6231anna.lamport@cuanschutz.edu

Enrique Soto, MD

enrique.2.soto@cuanschutz.edu

Principal Investigator:

Enrique Soto, MD

UCHealth Highlands Ranch Hospital

Recruiting

Highlands Ranch, Colorado, United States, 80129

Contacts

Anna Lamport

303-724-6231anna.lamport@cuanschutz.edu

Enrique Soto, MD

enrique.2.soto@cuanschutz.edu

Principal Investigator:

Enrique Soto, MD

Smilow Cancer Hospital Care Center - Derby

Recruiting

Derby, Connecticut, United States, 06418

Contacts

Carl Brown

475-241-1065carl.brown@yale.edu

Principal Investigator:

Maryam Lustberg, MD

Smilow Cancer Hospital Care Center - Fairfield

Recruiting

Fairfield, Connecticut, United States, 06824

Contacts

Carl Brown

475-241-1065carl.brown@yale.edu

Principal Investigator:

Maryam Lustberg, MD

Smilow Cancer Hospital at Glastonbury

Recruiting

Glastonbury, Connecticut, United States, 06033

Contacts

Carl Brown

475-241-1065carl.brown@yale.edu

Principal Investigator:

Maryam Lustberg, MD

Smilow Cancer Hospital Care Center - Greenwich

Recruiting

Greenwich, Connecticut, United States, 06830

Contacts

Carl Brown

475-241-1065carl.brown@yale.edu

Principal Investigator:

Maryam Lustberg, MD

Smilow Cancer Hospital Care Center - Guilford

Recruiting

Guilford, Connecticut, United States, 06437

Contacts

Carl Brown

475-241-1065carl.brown@yale.edu

Principal Investigator:

Maryam Lustberg, MD

Smilow Cancer Hospital at Saint Francis

Recruiting

Hartford, Connecticut, United States, 06105

Contacts

Carl Brown

475-241-1065carl.brown@yale.edu

Principal Investigator:

Maryam Lustberg, MD

Smilow Cancer Hospital - Yale New Haven Health

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Carl Brown

475-241-1065carl.brown@yale.edu

Principal Investigator:

Maryam Lustberg, MD, MPH

Yale University/Yale Cancer Center/Yale School of Medicine

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Carl Brown

475-241-1065carl.brown@yale.edu

Principal Investigator:

Maryam Lustberg, MD

Smilow Cancer Hospital Care Center - North Haven

Recruiting

North Haven, Connecticut, United States, 06473

Contacts

Carl Brown

475-241-1065carl.brown@yale.edu

Principal Investigator:

Maryam Lustberg, MD

Smilow Cancer Hospital Care Center - Torrington

Recruiting

Torrington, Connecticut, United States, 06790

Contacts

Carl Brown

475-241-1065carl.brown@yale.edu

Principal Investigator:

Maryam Lustberg, MD

Smilow Cancer Hospital Care Center - Trumbull

Recruiting

Trumbull, Connecticut, United States, 06611

Contacts

Carl Brown

475-241-1065carl.brown@yale.edu

Principal Investigator:

Maryam Lustberg, MD

Smilow Cancer Hospital Care Center - Waterbury

Recruiting

Waterbury, Connecticut, United States, 06708

Contacts

Carl Brown

475-241-1065carl.brown@yale.edu

Principal Investigator:

Maryam Lustberg

Smilow Cancer Hospital - Waterford

Recruiting

Waterford, Connecticut, United States, 06385

Contacts

Carl Brown

475-241-1065carl.brown@yale.edu

Principal Investigator:

Maryam Lustberg, MD

Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Contacts

Kristianne Enriquez

786-527-8537kristianne.enriquez@baptisthealth.net

Principal Investigator:

Reshma Mahtani, DO

Miami Cancer Institute

Recruiting

Plantation, Florida, United States, 33324

Contacts

Krystal Fernandez

954-837-1566Krystal.Fernandez@baptisthealth.net

Principal Investigator:

Reshma Mahtani, DO

Emory University Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Kevin Kalinsky, MD

404-778-1868kevin.michael.kalinsky@emory.edu

Principal Investigator:

Kevin Kalinsky, MD

Lewis Cancer and Research Pavilion

Recruiting

Savannah, Georgia, United States, 31405

Contacts

Stephanie Reyes

912-819-5723smiths1@sjchs.org

Principal Investigator:

Leonard Henry, MD

The University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

call or email to be connected

913-945-7552CTNurseNav@kumc.edu

Principal Investigator:

Ryan Rader, MD

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

Recruiting

Augusta, Maine, United States, 04330

Contacts

Sandra Neptune

207-626-4811Sandra.Neptune@mainegeneral.org

Principal Investigator:

Erin Adler, DO

The Jackson Laboratory (JAX) - Northern Light Cancer Care

Recruiting

Brewer, Maine, United States, 04412

Contacts

Laurie Lewis

207-973-4249llewis@northernlight.org

Principal Investigator:

Sarah Sinclair, DO

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Call

877-338-7425

Principal Investigator:

Erica Mayer, MD

Dana-Farber Brigham Cancer Center Foxborough

Recruiting

Foxborough, Massachusetts, United States, 02035

Contacts

877-DF-TRIAL

877-338-7425

Principal Investigator:

Sudha Bolla, MD

Dana-Farber Cancer Institute Merrimack Valley

Recruiting

Methuen, Massachusetts, United States, 01844

Contacts

877-DF-TRIAL

877-338-7425

Principal Investigator:

Ankur Mehta, MD

Dana-Farber Brigham Cancer Center at Milford Regional Medical Center

Recruiting

Milford, Massachusetts, United States, 01757

Contacts

877-DF-TRIAL

8773387425

Principal Investigator:

Natalie Sinclair, MD

Dana-Farber Brigham Cancer Center at South Shore Health

Recruiting

Weymouth, Massachusetts, United States, 02190

Contacts

877-DF-TRIAL

8773387425

Principal Investigator:

James Stoeckle, MD

Dana-Farber/New Hampshire Oncology-Hematology

Recruiting

Londonderry, New Hampshire, United States, 03053

Contacts

877-DF-TRIAL

877-338-7425

Principal Investigator:

Jeanna Walsh, MD

Penn Medicine - Princeton Health

Recruiting

Plainsboro, New Jersey, United States, 08536

Contacts

Florentin Racovitan

609-853-6764florentin.racovitan@pennmedicine.upenn.edu

Principal Investigator:

Ramy Sedhom, MD

Lovelace Medical Center - Saint Joseph Square

Recruiting

Albuquerque, New Mexico, United States, 87102

Contacts

Zemmie Pollock

505-727-3040ZPollock@salud.unm.edu

Principal Investigator:

Bernard Tawfik, MD

Lovelace Women's Hospital

Recruiting

Albuquerque, New Mexico, United States, 87109

Contacts

Zemmie Pollock

505-727-3040ZPollock@salud.unm.edu

Principal Investigator:

Bernard Tawfik, MD

Presbyterian Kaseman Hospital

Recruiting

Albuquerque, New Mexico, United States, 87110

Contacts

Monique Robertson

505-559-6100mrobertso2@phs.org

Principal Investigator:

Bernard Tawfik, MD

The University of New Mexico Comprehensive Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Crystal Pichette

505-925-0380cpichette@salud.unm.edu

Principal Investigator:

Bernard Tawfik, MD

Memorial Medical Center

Recruiting

Las Cruces, New Mexico, United States, 88011

Contacts

Deborah Brown

575-521-1554Deborah.Brown@LPNT.net

Principal Investigator:

Bernard Tawfik, MD

Presbyterian Rust Medical Center/Jorgensen Cancer Center

Recruiting

Rio Rancho, New Mexico, United States, 87124

Contacts

Andrea Yost

505-559-6100ayost3@phs.org

Principal Investigator:

Bernard Tawfik, MD

Levine Cancer Institute

Recruiting

Albemarle, North Carolina, United States, 28001

Contacts

Amanda Seifts

980-442-2391amanda.seifts@advocatehealth.org

Principal Investigator:

Neelam Desai, MD

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Amanda Seifts

980-442-2391amanda.seifts@advocatehealth.org

Principal Investigator:

Neelam Desai, MD

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28210

Contacts

Amanda Seifts

980-442-2391amanda.seifts@advocatehealth.org

Principal Investigator:

Neelam Desai, MD

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28211

Contacts

Amanda Seifts

980-442-2391amanda.seifts@advocatehealth.org

Principal Investigator:

Neelam Desai, MD

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28262

Contacts

Amanda Seifts

980-442-2391amanda.seifts@advocatehealth.org

Principal Investigator:

Neelam Desai, MD

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28277

Contacts

Amanda Seifts

980-442-2391amanda.seifts@advocatehealth.org

Principal Investigator:

Neelam Desai, MD

Levine Cancer Institute

Recruiting

Concord, North Carolina, United States, 28025

Contacts

Amanda Seifts

980-442-2391amanda.seifts@advocatehealth.org

Principal Investigator:

Neelam Desai, MD

Levine Cancer Institute

Recruiting

Forest City, North Carolina, United States, 28043

Contacts

Amanda Seifts

980-442-2391amanda.seifts@advocatehealth.org

Principal Investigator:

Neelam Desai, MD

Levine Cancer Institute

Recruiting

Gastonia, North Carolina, United States, 28054

Contacts

Amanda Seifts

980-442-2391amanda.seifts@advocatehealth.org

Principal Investigator:

Neelam Desai, MD

Levine Cancer Institute

Recruiting

Huntersville, North Carolina, United States, 28078

Contacts

Amanda Seifts

980-442-2391amanda.seifts@advocatehealth.org

Principal Investigator:

Neelam Desai, MD

Levine Cancer Institute

Recruiting

Lincolnton, North Carolina, United States, 28092

Contacts

Amanda Seifts

980-442-2391amanda.seifts@advocatehealth.org

Principal Investigator:

Neelam Desai, MD

Levine Cancer Institute

Recruiting

Matthews, North Carolina, United States, 28104

Contacts

Amanda Seifts

980-442-2391amanda.seifts@advocatehealth.org

Principal Investigator:

Neelam Desai, MD

Levine Cancer Institute

Recruiting

Monroe, North Carolina, United States, 28112

Contacts

Amanda Seifts

980-442-2391amanda.seifts@advocatehealth.org

Principal Investigator:

Neelam Desai, MD

Levine Cancer Institute

Recruiting

Shelby, North Carolina, United States, 28150

Contacts

Amanda Seifts

980-442-2391amanda.seifts@advocatehealth.org

Principal Investigator:

Neelam Desai, MD

Penn Medicine - Lancaster General Hospital

Recruiting

Lancaster, Pennsylvania, United States, 17601

Contacts

Susan Tollett

717-544-0511susan.tollett@pennmedicine.upenn.edu

Principal Investigator:

Ramy Sedhom, MD

Penn Medicine - Perelman Center for Advanced Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Erin Freitas

215-445-7277erin.freitas@pennmedicine.upenn.edu

Principal Investigator:

Ramy Sedhom, MD

Penn Medicine - Pennsylvania Hospital

Recruiting

Philidelphia, Pennsylvania, United States, 19106

Contacts

Clinical Research Team (RNs & CRCs)

PAhemoncResearch@uphs.upenn.edu

Principal Investigator:

Ramy Sedhorn, MD

Penn Medicine - Chester County Hospital

Recruiting

West Chester, Pennsylvania, United States, 19380

Contacts

Caroline Depiano

610-738-2522caroline.depiano@pennmedicine.upenn.edu

Principal Investigator:

Ramy Sedhom, MD

Smilow Cancer Hospital - Westerly

Recruiting

Westerly, Rhode Island, United States, 02891

Contacts

Carl Brown

475-241-1065carl.brown@yale.edu

Principal Investigator:

Maryam Lustberg, MD

St. Joseph's Candler Bluffton Campus

Recruiting

Bluffton, South Carolina, United States, 29910

Contacts

Stephanie Reyes

912-819-5723smiths1@sjchs.org

Principal Investigator:

Leonard Henry, MD

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

Recruiting

Hilton Head Island, South Carolina, United States, 29926

Contacts

Stephanie Reyes

9128195723smiths1@sjchs.org

Principal Investigator:

Leonard Henry, MD

Levine Cancer Institute

Recruiting

Rock Hill, South Carolina, United States, 29732

Contacts

Amanda Seifts

980-442-2391amanda.seifts@advocatehealth.org

Principal Investigator:

Neelam Desai, MD

Baptist Memorial Healthcare

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Amber Stone

901-226-1577Amber.Stone@bmhcc.org

Principal Investigator:

Glenn Roma, MD

Northwest Medical Specialties

Recruiting

Bonney Lake, Washington, United States, 98391

Contacts

Jodi Thiel

(253) 720-8143jthiel@southsoundcare.org

Principal Investigator:

Frank Senecal, MD

Northwest Medical Specialties

Recruiting

Federal Way, Washington, United States, 98003

Contacts

Jodi Thiel

(253) 720-8143jthiel@southsoundcare.org

Principal Investigator:

Frank Senecal, MD

Northwest Medical Specialties

Recruiting

Gig Harbor, Washington, United States, 98332

Contacts

Jodi Thiel

(253) 720-8143jthiel@southsoundcare.org

Principal Investigator:

Frank Senecal, MD

Northwest Medical Specialties

Recruiting

Olympia, Washington, United States, 98502

Contacts

Jodi Thiel

(253) 720-8143jthiel@southsoundcare.org

Principal Investigator:

Frank Senecal, MD

Northwest Medical Specialties

Recruiting

Puyallup, Washington, United States, 98373

Contacts

Jodi Thiel

(253) 720-8143jthiel@southsoundcare.org

Principal Investigator:

Frank Senecal, MD

Northwest Medical Specialties

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Jodi Thiel

(253) 720-8143jthiel@southsoundcare.org

Principal Investigator:

Frank Senecal, MD

More Information

Sponsor

American Society of Clinical Oncology

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • MBC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by American Society of Clinical Oncology on 2026-09-04.