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CDK4/6 Inhibitor Dosing Knowledge (CDK) undersøgelsen

30. oktober 2026 opdateret af: American Society of Clinical Oncology

Sammenligning af orale lægemiddeldoseringsstrategier hos ældre patienter med metastatisk brystkræft for at maksimere tolerancen og reducere seponering: CDK4/6-inhibitordoseringsviden (CDK)-undersøgelsen

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

500

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Medicin: Palbociclib 125mg

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

Medicin: Ribociclib 600mg

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

Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

American Society of Clinical Oncology

Samarbejdspartnere

Patient-Centered Outcomes Research Institute

Efterforskere

  • Ledende efterforsker: Julie Gralow, MD, American Society of Clinical Oncology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. oktober 2024

Primær færdiggørelse (Anslået)

31. august 2028

Studieafslutning (Anslået)

1. september 2028

Datoer for studieregistrering

Først indsendt

8. april 2024

Først indsendt, der opfyldte QC-kriterier

17. april 2024

Først opslået (Faktiske)

22. april 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Pro00075309

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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