Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

CDK4/6 Inhibitor Dosing Knowledge (CDK)-studien

30. oktober 2026 oppdatert av: American Society of Clinical Oncology

Sammenligning av orale legemiddeldoseringsstrategier hos eldre pasienter med metastatisk brystkreft for å maksimere toleransen og redusere seponering: CDK4/6-inhibitordoseringskunnskapsstudien (CDK)

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

500

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Arizona
      • Chandler, Arizona, Forente stater, 85224
        • Rekruttering
        • Ironwood Cancer & Research Centers
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sumeet Mendonca, MD
      • Gilbert, Arizona, Forente stater, 85297
        • Rekruttering
        • Ironwood Cancer & Research Centers
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sumeet Mendonca, MD
      • Glendale, Arizona, Forente stater, 85306
        • Rekruttering
        • Ironwood Cancer & Research Centers
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sumeet Mendonca, MD
      • Goodyear, Arizona, Forente stater, 85395
        • Rekruttering
        • Ironwood Cancer & Research Centers
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sumeet Mendonca, MD
      • Mesa, Arizona, Forente stater, 85202
        • Rekruttering
        • Ironwood Cancer & Research Centers
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sumeet Mendonca, MD
      • Mesa, Arizona, Forente stater, 85206
        • Rekruttering
        • Ironwood Cancer & Research Centers
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sumeet Mendonca, MD
      • Phoenix, Arizona, Forente stater, 85028
        • Rekruttering
        • Ironwood Cancer & Research Centers
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sumeet Mendonca, MD
      • Scottsdale, Arizona, Forente stater, 85260
        • Rekruttering
        • Ironwood Cancer & Research Centers
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sumeet Mendonca, MD
    • California
      • Eureka, California, Forente stater, 95501
        • Rekruttering
        • Providence Medical Foundation
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jarrod Holmes, MD
      • Santa Rosa, California, Forente stater, 95403
        • Rekruttering
        • Providence Medical Foundation
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jarrod Holmes, MD
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Rekruttering
        • University of Colorado Anschutz Medical Campus
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Enrique Soto, MD
      • Denver, Colorado, Forente stater, 80206
      • Highlands Ranch, Colorado, Forente stater, 80129
    • Connecticut
      • Derby, Connecticut, Forente stater, 06418
        • Rekruttering
        • Smilow Cancer Hospital Care Center - Derby
        • Hovedetterforsker:
          • Maryam Lustberg, MD
        • Ta kontakt med:
      • Fairfield, Connecticut, Forente stater, 06824
        • Rekruttering
        • Smilow Cancer Hospital Care Center - Fairfield
        • Hovedetterforsker:
          • Maryam Lustberg, MD
        • Ta kontakt med:
      • Glastonbury, Connecticut, Forente stater, 06033
        • Rekruttering
        • Smilow Cancer Hospital at Glastonbury
        • Hovedetterforsker:
          • Maryam Lustberg, MD
        • Ta kontakt med:
      • Greenwich, Connecticut, Forente stater, 06830
        • Rekruttering
        • Smilow Cancer Hospital Care Center - Greenwich
        • Hovedetterforsker:
          • Maryam Lustberg, MD
        • Ta kontakt med:
      • Guilford, Connecticut, Forente stater, 06437
        • Rekruttering
        • Smilow Cancer Hospital Care Center - Guilford
        • Hovedetterforsker:
          • Maryam Lustberg, MD
        • Ta kontakt med:
      • Hartford, Connecticut, Forente stater, 06105
        • Rekruttering
        • Smilow Cancer Hospital at Saint Francis
        • Hovedetterforsker:
          • Maryam Lustberg, MD
        • Ta kontakt med:
      • New Haven, Connecticut, Forente stater, 06510
        • Rekruttering
        • Smilow Cancer Hospital - Yale New Haven Health
        • Ta kontakt med:
        • Hovedetterforsker:
          • Maryam Lustberg, MD, MPH
      • New Haven, Connecticut, Forente stater, 06510
        • Rekruttering
        • Yale University/Yale Cancer Center/Yale School of Medicine
        • Hovedetterforsker:
          • Maryam Lustberg, MD
        • Ta kontakt med:
      • North Haven, Connecticut, Forente stater, 06473
        • Rekruttering
        • Smilow Cancer Hospital Care Center - North Haven
        • Hovedetterforsker:
          • Maryam Lustberg, MD
        • Ta kontakt med:
      • Torrington, Connecticut, Forente stater, 06790
        • Rekruttering
        • Smilow Cancer Hospital Care Center - Torrington
        • Hovedetterforsker:
          • Maryam Lustberg, MD
        • Ta kontakt med:
      • Trumbull, Connecticut, Forente stater, 06611
        • Rekruttering
        • Smilow Cancer Hospital Care Center - Trumbull
        • Hovedetterforsker:
          • Maryam Lustberg, MD
        • Ta kontakt med:
      • Waterbury, Connecticut, Forente stater, 06708
        • Rekruttering
        • Smilow Cancer Hospital Care Center - Waterbury
        • Hovedetterforsker:
          • Maryam Lustberg
        • Ta kontakt med:
      • Waterford, Connecticut, Forente stater, 06385
        • Rekruttering
        • Smilow Cancer Hospital - Waterford
        • Hovedetterforsker:
          • Maryam Lustberg, MD
        • Ta kontakt med:
    • Florida
      • Miami, Florida, Forente stater, 33176
        • Rekruttering
        • Miami Cancer Institute
        • Hovedetterforsker:
          • Reshma Mahtani, DO
        • Ta kontakt med:
      • Plantation, Florida, Forente stater, 33324
        • Rekruttering
        • Miami Cancer Institute
        • Hovedetterforsker:
          • Reshma Mahtani, DO
        • Ta kontakt med:
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Rekruttering
        • Emory University Winship Cancer Institute
        • Hovedetterforsker:
          • Kevin Kalinsky, MD
        • Ta kontakt med:
      • Hinesville, Georgia, Forente stater, 31313
        • Rekruttering
        • Liberty County Cancer Care
        • Ta kontakt med:
        • Hovedetterforsker:
          • Leonard Henry, MD
      • Pembroke, Georgia, Forente stater, 31321
        • Rekruttering
        • Pembroke Medical Oncology & St Joseph's/Candler Oncology Infusion Suite
        • Ta kontakt med:
        • Hovedetterforsker:
          • Leonard Henry, MD
      • Savannah, Georgia, Forente stater, 31405
        • Rekruttering
        • Lewis Cancer and Research Pavilion
        • Ta kontakt med:
        • Hovedetterforsker:
          • Leonard Henry, MD
      • Statesboro, Georgia, Forente stater, 30458
        • Rekruttering
        • Candler Medical Oncology Practice and Infusion
        • Ta kontakt med:
        • Hovedetterforsker:
          • Leonard Henry, MD
    • Indiana
      • Crown Point, Indiana, Forente stater, 46307
        • Rekruttering
        • Northwest Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Michael Tallarico, MD
      • Dyer, Indiana, Forente stater, 46311
        • Rekruttering
        • Northwest Cancer Center-Dyer
        • Ta kontakt med:
        • Hovedetterforsker:
          • Michael Tallarico, MD
      • Hobart, Indiana, Forente stater, 46342
        • Rekruttering
        • St. Mary Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Michael Tallarico, MD
      • Munster, Indiana, Forente stater, 46321
        • Rekruttering
        • Powers Health Cancer Research Foundation
        • Ta kontakt med:
        • Hovedetterforsker:
          • Michael Tallarico, MD
      • Valparaiso, Indiana, Forente stater, 46383
        • Rekruttering
        • Northwest Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Michael Tallarico, MD
    • Kansas
      • Westwood, Kansas, Forente stater, 66205
        • Rekruttering
        • The University of Kansas Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ryan Rader, MD
    • Maine
      • Augusta, Maine, Forente stater, 04330
        • Rekruttering
        • The Jackson Laboratory (JAX) - Harold Alfond Center for Cancer Care
        • Ta kontakt med:
        • Hovedetterforsker:
          • Erin Adler, DO
      • Brewer, Maine, Forente stater, 04412
        • Rekruttering
        • The Jackson Laboratory (JAX) - Northern Light Cancer Care
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sarah Sinclair, DO
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Rekruttering
        • Dana-Farber Cancer Institute
        • Hovedetterforsker:
          • Erica Mayer, MD
        • Ta kontakt med:
          • Call
          • Telefonnummer: 877-338-7425
      • Foxborough, Massachusetts, Forente stater, 02035
        • Rekruttering
        • Dana-Farber Brigham Cancer Center Foxborough
        • Ta kontakt med:
          • 877-DF-TRIAL
          • Telefonnummer: 877-338-7425
        • Hovedetterforsker:
          • Sudha Bolla, MD
      • Methuen, Massachusetts, Forente stater, 01844
        • Rekruttering
        • Dana-Farber Cancer Institute Merrimack Valley
        • Ta kontakt med:
          • 877-DF-TRIAL
          • Telefonnummer: 877-338-7425
        • Hovedetterforsker:
          • Ankur Mehta, MD
      • Milford, Massachusetts, Forente stater, 01757
        • Rekruttering
        • Dana-Farber Brigham Cancer Center at Milford Regional Medical Center
        • Hovedetterforsker:
          • Natalie Sinclair, MD
        • Ta kontakt med:
          • 877-DF-TRIAL
          • Telefonnummer: 8773387425
      • Weymouth, Massachusetts, Forente stater, 02190
        • Rekruttering
        • Dana-Farber Brigham Cancer Center at South Shore Health
        • Hovedetterforsker:
          • James Stoeckle, MD
        • Ta kontakt med:
          • 877-DF-TRIAL
          • Telefonnummer: 8773387425
    • New Hampshire
      • Londonderry, New Hampshire, Forente stater, 03053
        • Rekruttering
        • Dana-Farber/New Hampshire Oncology-Hematology
        • Hovedetterforsker:
          • Jeanna Walsh, MD
        • Ta kontakt med:
          • 877-DF-TRIAL
          • Telefonnummer: 877-338-7425
    • New Jersey
      • Englewood, New Jersey, Forente stater, 07631
        • Rekruttering
        • Englewood Hospital
        • Hovedetterforsker:
          • Jill Morrison, MD
        • Ta kontakt med:
      • Pennington, New Jersey, Forente stater, 08534
        • Rekruttering
        • Capital Health Medical Center - Hopewell
        • Ta kontakt med:
        • Hovedetterforsker:
          • Pamella Crilley, DO
      • Plainsboro, New Jersey, Forente stater, 08536
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87110
        • Rekruttering
        • Presbyterian Kaseman Hospital
        • Hovedetterforsker:
          • Bernard Tawfik, MD
        • Ta kontakt med:
      • Albuquerque, New Mexico, Forente stater, 87109
        • Rekruttering
        • Lovelace Women's Hospital
        • Hovedetterforsker:
          • Bernard Tawfik, MD
        • Ta kontakt med:
      • Albuquerque, New Mexico, Forente stater, 87102
        • Rekruttering
        • Lovelace Medical Center - Saint Joseph Square
        • Hovedetterforsker:
          • Bernard Tawfik, MD
        • Ta kontakt med:
      • Albuquerque, New Mexico, Forente stater, 87131
        • Rekruttering
        • The University of New Mexico Comprehensive Cancer Center
        • Hovedetterforsker:
          • Bernard Tawfik, MD
        • Ta kontakt med:
      • Las Cruces, New Mexico, Forente stater, 88011
        • Rekruttering
        • Memorial Medical Center
        • Hovedetterforsker:
          • Bernard Tawfik, MD
        • Ta kontakt med:
      • Rio Rancho, New Mexico, Forente stater, 87124
        • Rekruttering
        • Presbyterian Rust Medical Center/Jorgensen Cancer Center
        • Hovedetterforsker:
          • Bernard Tawfik, MD
        • Ta kontakt med:
    • North Carolina
      • Albemarle, North Carolina, Forente stater, 28001
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Neelam Desai, MD
        • Ta kontakt med:
      • Charlotte, North Carolina, Forente stater, 28204
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Neelam Desai, MD
        • Ta kontakt med:
      • Charlotte, North Carolina, Forente stater, 28210
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Neelam Desai, MD
        • Ta kontakt med:
      • Charlotte, North Carolina, Forente stater, 28211
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Neelam Desai, MD
        • Ta kontakt med:
      • Charlotte, North Carolina, Forente stater, 28262
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Neelam Desai, MD
        • Ta kontakt med:
      • Charlotte, North Carolina, Forente stater, 28277
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Neelam Desai, MD
        • Ta kontakt med:
      • Concord, North Carolina, Forente stater, 28025
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Neelam Desai, MD
        • Ta kontakt med:
      • Forest City, North Carolina, Forente stater, 28043
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Neelam Desai, MD
        • Ta kontakt med:
      • Gastonia, North Carolina, Forente stater, 28054
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Neelam Desai, MD
        • Ta kontakt med:
      • Huntersville, North Carolina, Forente stater, 28078
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Neelam Desai, MD
        • Ta kontakt med:
      • Lincolnton, North Carolina, Forente stater, 28092
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Neelam Desai, MD
        • Ta kontakt med:
      • Matthews, North Carolina, Forente stater, 28104
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Neelam Desai, MD
        • Ta kontakt med:
      • Monroe, North Carolina, Forente stater, 28112
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Neelam Desai, MD
        • Ta kontakt med:
      • Shelby, North Carolina, Forente stater, 28150
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Neelam Desai, MD
        • Ta kontakt med:
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45219
        • Rekruttering
        • University of Cincinnati Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mahmoud Charif, MD
      • West Chester, Ohio, Forente stater, 45069
        • Rekruttering
        • University of Cincinnati Medical Center - West Chester Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mahmoud Charif, MD
    • Pennsylvania
      • Lancaster, Pennsylvania, Forente stater, 17601
        • Rekruttering
        • Penn Medicine - Lancaster General Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ramy Sedhom, MD
      • Newton, Pennsylvania, Forente stater, 18940
        • Rekruttering
        • Capital Health Hematology Oncology Specialists
        • Ta kontakt med:
        • Hovedetterforsker:
          • Pamella Crilley, DO
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Rekruttering
        • Penn Medicine - Perelman Center for Advanced Medicine
        • Hovedetterforsker:
          • Ramy Sedhom, MD
        • Ta kontakt med:
      • Philidelphia, Pennsylvania, Forente stater, 19106
        • Rekruttering
        • Penn Medicine - Pennsylvania Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ramy Sedhorn, MD
      • West Chester, Pennsylvania, Forente stater, 19380
        • Rekruttering
        • Penn Medicine - Chester County Hospital
        • Hovedetterforsker:
          • Ramy Sedhom, MD
        • Ta kontakt med:
    • Rhode Island
      • Westerly, Rhode Island, Forente stater, 02891
        • Rekruttering
        • Smilow Cancer Hospital - Westerly
        • Hovedetterforsker:
          • Maryam Lustberg, MD
        • Ta kontakt med:
    • South Carolina
      • Bluffton, South Carolina, Forente stater, 29910
        • Rekruttering
        • St. Joseph's Candler Bluffton Campus
        • Ta kontakt med:
        • Hovedetterforsker:
          • Leonard Henry, MD
      • Hilton Head Island, South Carolina, Forente stater, 29926
        • Rekruttering
        • SC Cancer Specialists - Hilton Head at St. Joseph's/Candler
        • Hovedetterforsker:
          • Leonard Henry, MD
        • Ta kontakt med:
      • Rock Hill, South Carolina, Forente stater, 29732
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Neelam Desai, MD
        • Ta kontakt med:
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38120
        • Rekruttering
        • Baptist Memorial Healthcare
        • Hovedetterforsker:
          • Glenn Roma, MD
        • Ta kontakt med:
    • Washington
      • Bellevue, Washington, Forente stater, 98004
        • Rekruttering
        • Fred Hutchinson Cancer Center at Overlake Cancer Center
        • Hovedetterforsker:
          • Jennifer Specht, MD
        • Ta kontakt med:
          • Jennifer Specht, MD
          • Telefonnummer: 206-606-6889
          • E-post: jspecht@uw.edu
      • Bonney Lake, Washington, Forente stater, 98391
        • Rekruttering
        • Northwest Medical Specialties
        • Hovedetterforsker:
          • Frank Senecal, MD
        • Ta kontakt med:
      • Federal Way, Washington, Forente stater, 98003
        • Rekruttering
        • Northwest Medical Specialties
        • Hovedetterforsker:
          • Frank Senecal, MD
        • Ta kontakt med:
      • Gig Harbor, Washington, Forente stater, 98332
        • Rekruttering
        • Northwest Medical Specialties
        • Hovedetterforsker:
          • Frank Senecal, MD
        • Ta kontakt med:
      • Kirkland, Washington, Forente stater, 98034
        • Rekruttering
        • Fred Hutchinson Cancer Center at EvergreenHealth
        • Hovedetterforsker:
          • Jennifer Specht, MD
        • Ta kontakt med:
          • Jennifer Specht, MD
          • Telefonnummer: 206-606-6889
          • E-post: jspecht@uw.edu
      • Olympia, Washington, Forente stater, 98502
        • Rekruttering
        • Northwest Medical Specialties
        • Hovedetterforsker:
          • Frank Senecal, MD
        • Ta kontakt med:
      • Puyallup, Washington, Forente stater, 98373
        • Rekruttering
        • Northwest Medical Specialties
        • Hovedetterforsker:
          • Frank Senecal, MD
        • Ta kontakt med:
      • Seattle, Washington, Forente stater, 98109
        • Rekruttering
        • Fred Hutchinson Cancer Center
        • Hovedetterforsker:
          • Jennifer Specht, MD
        • Ta kontakt med:
          • Jennifer Specht, MD
          • Telefonnummer: 206-606-6889
          • E-post: jspecht@uw.edu
      • Seattle, Washington, Forente stater, 98133
        • Rekruttering
        • Fred Hutchinson Cancer Center at University of Washington-Northwest
        • Hovedetterforsker:
          • Jennifer Specht, MD
        • Ta kontakt med:
          • Jennifer Specht, MD
          • Telefonnummer: 206-606-6889
          • E-post: jspecht@uw.edu
      • Tacoma, Washington, Forente stater, 98405
        • Rekruttering
        • Northwest Medical Specialties
        • Hovedetterforsker:
          • Frank Senecal, MD
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Legemiddel: Palbociclib 125mg

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

Legemiddel: Ribociclib 600mg

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

Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Treatment Discontinuation (TTD)
Tidsramme: up to 48 months

Our primary outcome is time to CDK4/6 inhibitor discontinuation (TTD): the number of days between randomization and the last day the patient takes any dose of the same CDK4/6 inhibitor (regardless of drug holds, dose changes
up to 48 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Toxicity (grade 3-4 AEs)
Tidsramme: up to 48 months

Assessed in each arm of the study and study drug
up to 48 months
Event-Free survival (EFS)
Tidsramme: up to 48 months

Assessed in each arm of the study and study drug
up to 48 months
Quality of life assessed by patient reported outcomes
Tidsramme: up to 48 months

PROMIS-29 (3 domains of 12 questions, physical function, fatigue, participation in social activities), FACT-G Item GP5 (1 question)
up to 48 months
Time to dose reduction and escalation
Tidsramme: up to 48 months

For titrated arm. Assessed in each arm of the study and study drug
up to 48 months
Reason for not escalating
Tidsramme: up to 48 months

Assessed in each arm of the study and study drug
up to 48 months
Treatment received (missed doses, cumulative dose, etc.)
Tidsramme: up to 48 months

Assessed in each arm of the study and study drug
up to 48 months
Healthcare utilization (ED visits, hospital admissions, etc.)
Tidsramme: up to 48 months

ED visits, hospital admissions, etc., assessed in each arm of the study and study drug
up to 48 months
Body Mass Index
Tidsramme: up to 48 months

weight and height will be combined to report BMI in kg/m^2
up to 48 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

American Society of Clinical Oncology

Samarbeidspartnere

Patient-Centered Outcomes Research Institute

Etterforskere

  • Hovedetterforsker: Julie Gralow, MD, American Society of Clinical Oncology

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. oktober 2024

Primær fullføring (Antatt)

31. august 2028

Studiet fullført (Antatt)

1. september 2028

Datoer for studieregistrering

Først innsendt

8. april 2024

Først innsendt som oppfylte QC-kriteriene

17. april 2024

Først lagt ut (Faktiske)

22. april 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Pro00075309

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere