AzTrials
AzTrials

Breast CancerPhase 3PALLASNCT02513394

PALbociclib CoLlaborative Adjuvant Study

A Phase 3 study testing Palbociclib and Standard Adjuvant Endocrine Therapy in people with Breast Cancer, run by Alliance Foundation Trials, LLC. at 437 sites in 21 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Palbociclib and Standard Adjuvant Endocrine Therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,796 participants
Where
437 sitesin 21 countries
Study dates
Aug 2015to Dec 2028
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent prior to study specific procedures.
  • Age ≥18 years (or per national guidelines).
  • Pre- and postmenopausal women or men with Stage II (Stage IIA limited to max. 1000 patients) or Stage III early invasive breast cancer
  • Patients with multicentric and/or multifocal and/or bilateral early invasive breast cancer are eligible if all histopathologically examined tumors meet pathologic criteria for ER+ and/or PR+ and HER2-.
  • Patients must have histologically confirmed ER+ and/or PR+, HER2-, early invasive breast cancer.
  • Patients must have undergone adequate (definitive) breast surgery for the current malignancy.
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  • FFPE tumor tissue block must be confirmed to be received at the central sample repository prior to randomization.
  • ECOG performance status 0-1.
  • Patients must be able and willing to swallow and retain oral medication.
  • Serum or urine pregnancy test must be negative in premenopausal women within 14 days of randomization, or in women with amenorrhea of less than 12 months at time of randomization.
  • Patients who received neo/adjuvant therapy must be after last dose of chemotherapy and/or biologic therapy and must have sufficient resolution of side effects.
  • Patients who received breast/axilla/post-mastectomy chest wall radiotherapy must be after last dose of radiotherapy and must have sufficient resolution of side effects.
  • Patients must have sufficient resolution of any surgical side effects (no active wound healing complications).
  • -Patients must either be initiating or have already started adjuvant hormonal treatment. -
  • Patients who already received neo/adjuvant endocrine therapy are eligible as long as they are enrolled within 12 months of initial histological diagnosis and after completing no more than 6 months of adjuvant endocrine therapy.
  • Absolute neutrophil count ≥ 1,500/µL
  • Platelets ≥ 100,000/ mm3
  • Hemoglobin ≥ 10g/dL
  • Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome.
  • Aspartate amino transferase (AST or SGOT) and alanine amino transferase (ALT or SGPT) ≤ 1.5 × institutional ULN.
  • Serum creatinine below the upper limit of the institutional normal range (ULN) or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.

Who cannot join

  • Concurrent therapy with other Investigational Products.
  • Prior therapy with any CDK inhibitor.
  • Patients with Stage I or IV breast cancer are not eligible.
  • History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib.
  • Patients receiving any medications or substances that are potent inhibitors or inducers of
  • CYP3A isoenzymes within 7 days of randomization.
Show all 13Show fewer
  • Uncontrolled intercurrent illness that would limit compliance with study requirements.
  • Pregnant women, or women of childbearing potential without a negative pregnancy test within 14 days prior to randomization.
  • Patients with a history of any malignancy are ineligible
  • Patients who previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy.
  • Patients on antiretroviral therapy.
  • Patients with clinically significant history of any chronic liver disease.
  • Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen therapy is allowable).

Trial locations and contacts

437 sites in 21 countries.

437 sites in 21 countries

United States192 sites

  • Avera Cancer Institute-Aberdeen

    Aberdeen, South Dakota, 57401

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • McFarland Clinic, P.C.

    Ames, Iowa, 50010

  • Kaiser Permanente Anaheim Medical Center

    Anaheim, California, 92806

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Cancer Center

    Anchorage, Alaska, 99508

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54913

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Kaiser Permanente Baldwin Park Medical Center

    Baldwin Park, California, 91706

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21218

  • MedStar Franklin Square Medical Center Winberg Cancer Institute

    Baltimore, Maryland, 21237

  • Medstar Union Memorial Hospital

    Baltimore, Maryland, 21237

  • JHU Sidney Kimmel Comprehensive Cancer Center LAPS

    Baltimore, Maryland, 21287

  • Frederick Regional Health System James M Stockman Cancer Institute

    Baltimore, Maryland, 21701

  • Eastern Maine Medical Center d/b/a Northern Light Cancer Institute

    Bangor, Maine, 04401

  • Kaiser Permanente Bellflower Medical Center

    Bellflower, California, 90706

  • Maryland Oncology Hematology PA

    Bethesda, Maryland, 20817

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52403

  • CAMC Cancer Center

    Charleston, West Virginia, 25304

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • The Charlotte-Mecklenburg Hospital Authority

    Charlotte, North Carolina, 28204

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago Cancer Center LAPS

    Chicago, Illinois, 60637

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Lexington Medical Center/Lexington Oncology Associates

    Columbia, South Carolina, 29169

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • New Hampshire Oncology-Hematology PA, Concord

    Concord, New Hampshire, 03301

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 11326

  • Cancer Care Specialist of Central Illinois

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Western States Cancer Research NCORP

    Denver, Colorado, 80222

  • Iowa Oncology Research Assoc

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates - Des Moines

    Des Moines, Iowa, 50309

  • Essentia Health NCORP

    Duluth, Minnesota, 55805

  • Hematology & Oncology Associates of Northeastern PA

    Dunmore, Pennsylvania, 18512

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Hematology Oncology Associates of Central New York - East Syracuse

    East Syracuse, New York, 13057

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • NorthShore University Health System - Evanston Hospital

    Evanston, Illinois, 60201

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Kaiser Permanente Fontana Medical Center

    Fontana, California, 92335

  • Cancer Research Consortium of West Michigan NCORP

    Grand Rapids, Michigan, 49503

  • Spectrum Health Butterworth Research Pharmacy

    Grand Rapids, Michigan, 49503

  • HSHS Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Marin Cancer Care

    Greenbrae, California, 94904

  • Marin Cancer Center

    Greenbrae, California, 94904

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Kaiser Permanente Harbor City Medical Center

    Harbor City, California, 90710

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • New Hampshire Oncology-Hematology PA

    Hooksett, New Hampshire, 03106

  • Solinsky Center for Cancer Care

    Hooksett, New Hampshire, 03106

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

  • Houston Methodist Hospital Cancer Center

    Houston, Texas, 77030

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University - Melvin and Bren Simon Cancer Center LAPS

    Indianapolis, Indiana, 46202

  • Kaiser Permanente Irvine Medical Center

    Irvine, California, 92618

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Queens Hospital Center

    Jamaica, New York, 11432

  • Joliet Oncology Hematology Associates Limited

    Joliet, Illinois, 60435

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Kinston Medical Specialists, PA

    Kinston, North Carolina, 28504

  • Gunderson Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • Doctors Hospital of Laredo

    Laredo, Texas, 78045

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Norris Cotton Cancer Center - Nashua

    Lebanon, New Hampshire, 03766

  • University of Kentucky-Markey Cancer Center

    Lexington, Kentucky, 40536

  • Nebraska Hematology and Oncology

    Lincoln, Nebraska, 68506

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • Trinity Health Michigan

    Livonia, Michigan, 48152

  • Long Beach Memorial Medical Center - Todd Cancer Institute

    Long Beach, California, 90806

  • Kaiser Permanente Sunset Medical Center

    Los Angeles, California, 90027

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Norton Cancer Institute - Brownsboro

    Louisville, Kentucky, 20202

  • Lowell General Hospital

    Lowell, Massachusetts, 01852

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Cleveland Clinic Cancer Center/Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • University of Miami Miller School of Medicine Sylvester Cancer Center

    Miami, Florida, 33136

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Wheaton Franciscan Healthcare - St. Joseph

    Milwaukee, Wisconsin, 53210

  • Columbia St. Mary's Water Tower Medical Commons

    Milwaukee, Wisconsin, 53711

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • Southern Cancer Center PC - Providence

    Mobile, Alabama, 36608

  • IU Health Ball Memorial Hospital

    Muncie, Indiana, 47303

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37204

  • Nashville General Hospital at Meharry

    Nashville, Tennessee, 37208

  • Memorial Sloan Cancer Center - Hartford Healthcare Center Institute at HOCC

    New Britain, Connecticut, 06053

  • Rutgers Cancer Center Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Northwell Health NCORP

    New Hyde Park, New York, 11042

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Beth Israel Medical Center - New York

    New York, New York, 10011

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center - LAPS

    New York, New York, 10065

  • Christiana Health System - Christiana Hospital

    Newark, Delaware, 19718

  • Kaiser Permanente Oakland Medical Center

    Oakland, California, 94611

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Cancer Alliance of Nebraska

    Omaha, Nebraska, 68106

  • Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Oneonta FoxCare Center

    Oneonta, New York, 13820

  • Advent Health Orlando

    Orlando, Florida, 32804

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Palo Alto Medical Foundation Health Care

    Palo Alto, California, 94301

  • Kaiser Permanente Panorama City Medical Center

    Panorama City, California, 91402

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19106

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Mayo Clinic in Arizona

    Phoenix, Arizona, 85054

  • First Health of the Carolinas - Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC MaGee Women's Hospital

    Pittsburgh, Pennsylvania, 15213

  • University of Pittsburgh Cancer Institute- Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Beth Israel Deaconess Hospital - Plymouth Jordan Club Cancer Center

    Plymouth, Massachusetts, 02360

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • Wheaton Franciscan Healthcare-All Saints

    Racine, Wisconsin, 53405

  • Monument Health Rapid City Hospital

    Rapid City, South Dakota, 57701

  • Rapid City Regional Hospital/Regional Cancer Care Institute

    Rapid City, South Dakota, 57701

  • VCU Massey Cancer Center

    Richmond, Virginia, 23298

  • Kaiser Permanente Riverside Medical Center

    Riverside, California, 92505

  • Mayo Clinic-Rochester

    Rochester, Minnesota, 55902

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • OSF Saint Anthony Medical Center

    Rockford, Illinois, 61108

  • Phelps Country Regional Medical Center

    Rolla, Missouri, 65401

  • Kaiser Permanente Roseville Medical Center

    Roseville, California, 95661

  • Kaiser Permanente Sacramento Medical Center

    Sacramento, California, 95825

  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Metro Minnesota Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Tidal Health Peninsula Regional

    Salisbury, Maryland, 21801

  • Huntsman Cancer Institute - University of Utah

    Salt Lake City, Utah, 84112

  • University of California

    San Diego, California, 92093

  • Kaiser Permanente San Diego Medical Center

    San Diego, California, 92120

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Kaiser Permanente San Francisco Medical Center

    San Francisco, California, 94115

  • UCSF Helen Diller Comprehensive Cancer Center

    San Francisco, California, 94115

  • Kaiser Permanente San Jose Medical Center

    San Jose, California, 95119

  • Kaiser Permanente San Leandro Medical Center

    San Leandro, California, 94577

  • Kaiser Permanente San Marcos Medical Center

    San Marcos, California, 92078

  • Kaiser Permanente Santa Clara Medical Center

    Santa Clara, California, 95051

  • Memorial Health University Medical Center

    Savannah, Georgia, 317404

  • New England Cancer Specialists - Scarborough

    Scarborough, Maine, 04074

  • Holy Cross Hospital

    Silver Spring, Maryland, 20910

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60017

  • NorthShore Hematology Oncology-Libertyville

    Skokie, Illinois, 60077

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876

  • Kaiser Permanente South San Francisco Medical Center

    South San Francisco, California, 94080

  • Cancer Research for the Ozarks NCORP

    Springfield, Missouri, 65807

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Stanford Women's Cancer Center

    Stanford, California, 94305

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Montefiore Medical Center - Einstein Campus

    The Bronx, New York, 10461

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Kaiser Permanente Vallejo Medical Center

    Vallejo, California, 94589

  • Kaiser Permanente Walnut Creek Medical Center

    Walnut Creek, California, 94596

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Covenant Medical Center

    Waterloo, Iowa, 50702

  • Orchard Healthcare Research Inc.

    Waukesha, Wisconsin, 53188

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188

  • Wheaton Franciscan Healthcare - Wauwatosa

    Wauwatosa, Wisconsin, 53226

  • Kaiser Permanente Cadillac Medical Center

    West Los Angeles, California, 90034

  • Kaiser Permanente Woodland Hills Medical Center

    Woodland Hills, California, 91367

  • Reading Hospital/McGlinn Cancer Institute

    Wyomissing, Pennsylvania, 19610

  • WellSpan Health York Cancer Center

    York, Pennsylvania, 17403

Other trials in United States

Spain46 sites

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, 15006

  • Centro Oncologico de Galicia

    A Coruña, 15009

  • Hospital General Universitario Alicante

    Alicante, 03010

  • ICO Badalona

    Badalona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Quirón Dexeus

    Barcelona, 08028

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital General de Granollers

    Barcelona, 08402

  • Instituto Catalán de Oncología (ICO) de L'Hospitalet de Llobregat

    Barcelona, 08908

  • Hospital Vall d´Hebron

    Barcelona, 8035

  • Hospital Universitario de Burgos

    Burgos, 09006

  • San Pedro de Alcántara

    Cáceres, 10003

  • Consorcio Hospitalario Provincial de Castellon

    Castellon, 12002

  • Hospital Reina Sofía

    Córdoba, 14004

  • Hospital General Universitario de Elche

    Elche, 03203

  • ICO/ H. Josep Trueta

    Girona, 17007

  • Complejo asistencial universitario de Leon

    León, 24001

  • Hospital Universitario Gregorio Marañón

    Madrid, 28007

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital La Paz, Servicio de Oncologia Médica

    Madrid, 28046

  • CIOCC - Centro Integral Oncológico Clara Campal / Hospital HM Universitario Sanchinarro

    Madrid, 28050

  • Hospital Puerta de Hierro Majadahonda, Oncologia Médica

    Madrid, 28222

  • Hospital Universitario Fundacion Alcorcón

    Madrid, 28922

  • Hospital Clínico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital General Universitario José Mª Morales Meseguer

    Murcia, 30008

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospitali Universitari son Espases

    Palma, 07120

  • Hospital Son Llatzer

    Palma, 07198

  • Complejo Hospitalario de Navarra

    Pamplona, 31008

  • Hospital Universitari Sant Joan de Reus

    Reus, 43204

  • Hospital Universitario Donostia

    San Sebastián, 20014

  • Hospital de Sant Juan Despi Moisés Broggi

    Sant Joan Despì, 08970

  • Hospital Clinico Universitario de Santiago

    Santiago, 15706

  • Hospital Unversitario Virgen Macarena

    Seville, 41009

  • Hospital Quirón Sagrado Corazón

    Seville, 41013

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Consorci Sanitari de Terrassa

    Terrassa, 08227

  • Hospital Virgen de la Salud

    Toledo, 45004

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hosital Arnau de Vilanova Valencia

    Valencia, 46015

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Germany27 sites

  • University Hospital Aachen

    Aachen, 52074

  • Praxisklinik Krebsheilkunde für Frauen

    Berlin, 10367

  • Helios Klinikum Berlin-Buch

    Berlin, 13125

  • Studienzentrum City

    Berlin, 14169

  • Marienhospital Bottrop, Klinik für Gynäkologie und Geburtshilfe

    Bottrop, 46236

  • Studien GbR Braunschweig, Lorenz&HeckerWesche

    Braunschweig, 38100

  • Praxis und Tagesklinik für gynäkologische Onkologie,

    Ebersberg, 85560

  • MVZ Eggenfelden

    Eggenfelden, 84307

  • Frauenklinik/University Hospital Erlangen

    Erlangen, 91054

  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt, 60389

  • Agaplesion Markus Krankenhaus

    Frankfurt, 60431

  • Klinikum Frankfurt Höchst

    Frankfurt, 65929

  • Onkol. GP Dres. med. Wilke/Wagner/Petzoldt

    Fürth, 90766

  • Universitätsfrauenklinik Halle (Saale)

    Halle, '06120

  • University Medical Center Hamburg-Eppendorf, Department of Gynecology

    Hamburg, 20246

  • Albertinen Krankenhaus

    Hamburg, 22457

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133

  • Elisabeth Krankenhaus Kassel Brustzentrum

    Kassel, 34125

  • St. Elisabeth Krankenhaus Leipzig

    Leipzig, 04277

  • St. Vincenz KH Limburg Frauenklinik

    Limburg, 65549

  • UKSH Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe

    Lübeck, 23538

  • Universitätsmedizin Mainz

    Mainz, 55131

  • Praxis Gynäkologie Arabella

    München, 81925

  • University Clinic Oldenburg

    Oldenburg, 26133

  • Oncologianova GmbH

    Recklinghausen, 45657

  • HELIOS Klinik Rottweil - Gynäkologie

    Rottweil, 78628

  • St. Josefs-Hospital

    Wiesbaden, 65189

Other trials in Germany

Austria24 sites

  • LKH Feldkirch, Department of Internal Medicine

    Feldkirch, 6807

  • LKH Univ Klinikum Graz, Dept of Internal Med. and Oncology

    Graz, 8036

  • Medical University of Graz, Gyn. Dept.

    Graz, 8036

  • University Hospital Innsbruck, Department of Obstetrics and Gynaecology

    Innsbruck, 6020

  • BKH Kufstein, Innere Medizin

    Kufstein, 6330

  • LKH Hochsteiermark Leoben

    Leoben, 8700

  • Hospital of the Sisters of Charity Linz, Surg. Dept., Breast Health Center

    Linz, 4010

  • Kepler Universitätsklinikum Med. Campus III

    Linz, 4020

  • Weinviertelklinikum Mistelbach, Department of Surgery

    Mistelbach, 2130

  • BHS Ried, Abt. f. Gynäkologie

    Ried, 4910

  • LKH Salzburg, Univ. Klinik f. Innere Med. III

    Salzburg, 5020

  • Universitätsklinikum St. Pölten, Innere Medizin

    Sankt Pölten, 3100

  • Breast Centre Dr. Wette Viktor

    Sankt Veit an der Glan, 9300

  • Phyrn-Eisenwurzen Klinikum Steyr

    Steyr, 4400

  • Medical University of Vienna Department of Obstetrics and Gynaecology

    Vienna, 1090

  • Medical University Vienna - Coop Group Surgery/Oncology

    Vienna, 1090

  • Hospital Hietzing, Gynecology

    Vienna, 1130

  • St. Josef Krankenhaus, Department of Internal I

    Vienna, 1130

  • Klinik Ottakring

    Vienna, 1160

  • Salzkammergut-Klinikum Vöcklabruck

    Vöcklabruck, 4840

  • Brustordination Dr. Thiel

    Weiz, 8160

  • Klinikum Wels - Grieskirchen GmbH, Department of Internal Medicine IV

    Wels, 4600

  • Landesklinikum Wr. Neustadt, Department of Surgery

    Wiener Neustadt, 2700

  • LKH Wolfsberg, Department of Surgery

    Wolfsberg, 9400

Other trials in Austria

Australia21 sites

  • Flinders Drive

    Bedford Park, South Australia, 5042

  • Southern Highlands Cancer Centre

    Bowral, New South Wales, 2576

  • Royal Brisbane & Women's Hospital

    Brisbane, Queensland, 4029

  • St John of God Bunbury Hospital

    Bunbury, Western Australia, 6231

  • Coffs Harbour Health Campus - MNCCI

    Coffs Harbour, New South Wales, 2450

  • The Northern Hospital

    Epping, Victoria, 3076

  • St Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Peninsula Health - Frankston Hospital

    Frankston, Victoria, 3199

  • The Breast & Endocrine Centre

    Gateshead, New South Wales, 2290

  • University Hospital, Geelong

    Geelong, Victoria, 3220

  • Gosford Hospital

    Gosford, New South Wales, 2500

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2109

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Peninsula Health - Frankston Hospital

    Melbourne, Victoria

  • Fiona Stanley Hospital

    Murdoch, Western Australia

  • Breast Cancer Research Centre - WA

    Nedlands, Western Australia, 6009

  • Orange Health Service

    Orange, New South Wales, 2800

  • Western Health, Sunshine Hospital

    St Albans, Victoria, 3021

  • South West Healthcare, Warrnambool

    Warrnambool, Victoria, 3280

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

Other trials in Australia

Canada19 sites

  • BC Cancer Agency- Abbotsford Centre

    Abbotsford British Columbia, British Columbia, V2S0C2

  • Tom Baker Cancer Centre - Dept. of Oncology

    Calgary, Alberta, T2N4N2

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H2Y9

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V5C2

  • BC Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior

    Kelowna, British Columbia, V1Y5L3

  • Kingston General Hospital, Cancer Centre of Southeastern Ontario/Oncology

    Kingston, Ontario, K7L5P9

  • Grand River Regional Cancer Center

    Kitchener, Ontario, N2G1G3

  • The Vitalite Health Network - Dr. Leon Richard

    Moncton, New Brunswick, E1C8X3

  • The Jewish General Hospital

    Montreal, Quebec, H2L4M1

  • CHUM Hôtel Dieu

    Montreal, Quebec, H2W1T8

  • CHU de Québec - Hôpital du St Sacrement

    Québec, Quebec, G1S4L8

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T7TI

  • Horizon Health Network - Saint John Regional Hospital

    Saint John, New Brunswick, E2L4L4

  • Saskatoon Cancer Center, University of Saskatchewan

    Saskatoon, Saskatchewan, S7N4H4

  • Niagara Health System

    St. Catharines, Ontario, L2S0A9

  • Sunnybrook

    Toronto, Ontario, M4N3M

  • University Health Network Princess Margaret Cancer Centre

    Toronto, Ontario, M5G1X5

  • BC Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z4E6

  • CancerCare Manitoba - St. Boniface Hospital

    Winnipeg, Manitoba, R2H2A6

Other trials in Canada

United Kingdom16 sites

  • City Hospital Birmingham

    Birmingham, B18 7QH

  • University Hospitals Bristol NHS Foundation Trust

    Bristol, BS2 8ED

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • Royal Marsden Hospital Chelsea

    Chelsea, SW3 6JJ

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • University Hospitals of Leicester

    Leicester, LE1 5WW

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 7EH

  • The Royal Marsden Sutton

    London, SW3 6JJ

  • Charing Cross Hospital

    London, W6 8RF UK

  • Maidstone Hospital, Kent Oncology Centre

    Maidstone, ME16 9QQ

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Northern Centre for Cancer Care

    Newcastle upon Tyne, NE7 7DN

  • Nottingham University Hospitals NHS TRUST UK

    Nottingham, NG5 1PB

  • Weston Park Hospital, Sheffield Teaching Hospitals

    Sheffield, S10 2SJ

  • Royal Cornwall Hospitals NHS Trust, Oncology Trials, Sunrise Centre

    Truro, TR1 3LQ

Other trials in United Kingdom

Italy13 sites

  • Azienda Ospedaliero-Universitaria di Ferrara

    Ferrara, 44124

  • Azienda Ospedaliero-Universitaria Careggi/Florence University/Radiation Oncology Unit

    Florence, 50134

  • Department of Internal Medicine (DIMI) - IRCCS San Martino University Hospital

    Genoa, 16132

  • P.O. Misericordia AUSL Toscana Sud Est

    Grosseto, 58100

  • Ospedale "Mater Salutis" di Legnago, Dept. of Medical Oncology

    Legnago, 37045

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) IRCCS

    Meldola, 47014

  • Ospedale San Raffaele

    Milan, 20132

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Policlinico di Monza - Istituto di Oncologia del Policlinico di Monza

    Monza, 20900

  • Medical Oncology Unit; University Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)

    Parma, 43100

  • Nuovo Ospedale di Prato (NOP) - Azienda USL4 Prato

    Prato, 59100

  • ASST Bergamo Ovest

    Treviglio, 24047

  • S. Anna Hospital (Ospedale Sant'Anna)- Turin

    Turin, 10126

Other trials in Italy

Switzerland13 sites

  • Kantonspital Baden

    Baden, Canton of Aargau, 5404

  • Dep. Oncology, University Hospital

    Basel, 4031

  • IOSI-Breast Cancer Unit-Ospedale San Giovanni-Bellinzona

    Bellinzona, Canton Ticino, 6500

  • Kantonsspital Graubünden

    Chur, Kanton Graubünden, 7000

  • HFR Fribourg, Oncology Department

    Fribourg, 1708

  • Hôpitaux Universitaires de Genève

    Geneva, Canton of Geneva, 1211

  • Fondazione Oncologia Lago Maggiore, Locarno

    Locarno, Canton Ticino, 6600

  • Luzerner Kantonsspital, Dept. of Medical Oncology

    Lucerne, 6000

  • Onkologisches Forschungszentrum Klinik St. Anna, Hirslanden

    Lucerne, 6006

  • Kantonsspital St.Gallen, Onkologie/Hämatologie

    Sankt Gallen, 9007

  • Spital STS AG, Onkologiezentrum Thun-Berner Oberland

    Thun, Canton of Bern, 3600

  • Brust-Zentrum Zürich

    Zurich, 8008

  • Universitätsspital Zürich, Klinik für Onkologie

    Zurich, 8091

Other trials in Switzerland

Belgium12 sites

  • OLV ziekenhuis Aalst/Radiotherapy-Oncology

    Aalst, 9300

  • CHU Saint Pierre/Medical Oncology

    Brussels, 1000

  • Institut Jules Bordet/Medical Oncology Department

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc, Oncologisch centrum

    Brussels, 1200

  • Grand Hopital de Charleroi - Oncologie-hématologie

    Charleroi, 6000

  • University Hospital Antwerp (UZA)

    Edegem, 2650

  • UZ Leuven/ Gynaecologie-Oncologie

    Leuven, 3000

  • CHC - Saint-Joseph/Oncology-Hematology

    Liège, 4000

  • CHU Sart Tilman Liège (Medical Oncology)

    Liège, 4000

  • Clinique et Maternite Sainte-Elisabeth - Oncology Department

    Namur, 5000

  • CHR - Centre Hospitalier Peltzer La Tourelle/ Oncology Department

    Verviers, 4800

  • GZA Ziekenhuizen (Campus Sint-Augustinus) / Oncologische Centrum

    Wilrijk, 2610

Other trials in Belgium

Ireland9 sites

  • Bon Secours Hospital, Cork

    Cork

  • Cork University Hospital, Oncology Clinical Trials Unit

    Cork

  • Beaumont Hospital - Cancer Clinical Trials Unit

    Dublin

  • Mater Misericordiae University Hospital

    Dublin

  • St James's Hospital, Cancer Clinical Trials Office, Old Admin Building,

    Dublin

  • St Vincent Hospital - Medical Oncology Research Department

    Dublin

  • University Hospital Limerick, Midwestern Cancer Centre

    Limerick

  • Sligo University Hospital

    Sligo

  • University Hospital Waterford, Cancer Research Department

    Waterford

Other trials in Ireland

Japan6 sites

  • Chiba Cancer Center

    Chiba, 260-8717

  • Kyoto University Hospital/Breast Surgery

    Kyoto, 606-8507

  • Nagoya City University Hospital/Dept. of Breast & Endocrine Surgery

    Nagoya, Aichi-ken, 467-8601

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Department of Breast Surgery National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

Other trials in Japan

Netherlands6 sites

  • Máxima Medisch Centrum

    Eindhoven, 5631 BM

  • Zuyderland Ziekenhuis, Oncology

    Geleen, 6162 BG

  • St Antonius Hospital

    Nieuwegein, 3435 CM

  • Hagaziekenhuis

    The Hague, 2545 AA

  • Zaans Medical Center

    Zaandam, 1502 DV

  • Isala, Dept of Medical Oncology

    Zwolle, 8025 AB

Other trials in Netherlands

Hungary5 sites

  • Országos Onkológiai Intézet - "B" Belgyógyászati Onkológiai és Klinikai Farmakológiai Osztály

    Budapest, 1122

  • Uzsoki Utcai Kórház - Onkoradiológia, Sugárterápia, Fővárosi Onkoradiológiai Központ

    Budapest, 1145

  • University of Debrecen Medical Center, Clinic of Oncology

    Debrecen, 4032

  • Petz Aladár Megyei Oktatókórház - Onkoradiológiai Osztály

    Győr, 9023

  • Szegedi Tudomanyegyetem Általános Orvostudományi Kar Szent-Györgyi Albert Klinikai Központ, Onkoterápiás Klinika

    Szeged, 6720

Other trials in Hungary

Portugal5 sites

  • Instituto Português de Oncologia (IPO) de Lisboa Francisco Gentil

    Lisbon, 1099-023

  • Centro Clinico Champalimaud

    Lisbon, 1400-038

  • Hospital da Luz

    Lisbon, 1500-650

  • CUF Descobertas Hospital, Hemato-Oncologia

    Lisbon, 1998-018

  • Instituto Português de Oncologia (IPO) Francisco Gentil do Porto

    Porto, 4200

Other trials in Portugal

Sweden5 sites

  • Gävle Hospital, Dept. of Oncology

    Gävle, 801 87

  • Sahlgrenska University Hospital, Dept. Oncology

    Gothenburg, 413 45

  • Universitetssjukhuset Örebro (University Hospital) Örebro, Onkologkliniken

    Örebro, 701 85

  • Karolinska Universitetssjukhuset, Bröstcentrum A2:00

    Stockholm, 171 76

  • Akademiska Sjukhuset Uppsala (University Hospital), Onkologkliniken

    Uppsala, 751 85

Other trials in Sweden

Taiwan5 sites

  • Changhua Christian Hospital/General Surgery

    Changhua, Changhua County, 500

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

  • National Cheng Kung University Hospital, Division of Hemato-Oncology, Dept. Internal Medicine

    Tainan, 704

  • National Taiwan University Hospital/Department of Surgery

    Taipei, 100

  • Taipei Veterans General Hospital/General Surgery

    Taipei, 112

Other trials in Taiwan

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne (UCK), Klinika Onkologii I Radioterapii

    Gdansk, 80-952

  • Instytut MSF Spółka z ograniczoną odpowiedzialnością

    Lodz

  • Opolskie Centrum Onkologii, Oddzial Onkologii Klinicznej

    Opole, 45-001

  • Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

Israel3 sites

  • Rabin Medical Center (RMC)

    Petah Tikva, Central District, 49100

  • Sheba Medical Center Tel Hashomer

    Ramat Gan, Tel Aviv, 52621

  • Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Mexico3 sites

  • National Cancer Institute Mexico, Breast Cancer Department

    Mexico City, 14080

  • Centro Médico Zambrano Hellion

    Monterrey, Nuevo León, 66278

  • Centro Oncológico Estatal ISSEMYM

    Toluca, Toluca, 50180

Other trials in Mexico

South Korea3 sites

  • Seoul National University Hospital, Hematology-Medical Oncology

    Seoul, 03080

  • Severance Hospital Medical Doctor at Department of Medical Oncology

    Seoul, 03722

  • Samsung Medical Centre, Breast Cancer Center, Department of Medicine, Division of Hematology/Oncology

    Seoul, 06351

Other trials in South Korea

About this study

Official title: PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer

This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC).

The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.

Conditions
Breast Cancer
Being tested
Palbociclib, Standard Adjuvant Endocrine Therapy
Keywords
HR+/HER2- breast cancer, Palbociclib
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02513394
Study groupRoleWhat they receive
Arm AExperimentalPalbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
Receives: Drug: Palbociclib; Drug: Standard Adjuvant Endocrine Therapy
Arm BOtherStandard adjuvant endocrine therapy for a duration of at least 5 years.
Receives: Drug: Standard Adjuvant Endocrine Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Invasive Disease Free Survival (iDFS)

    Invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, second primary invasive cancer of non-breast origin or death from any cause. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported.

    Measured: 4 years

Secondary outcomes (4)

  1. Invasive Disease Free Survival (iDFS) Excluding Second Primary Invasive Cancers of Non-breast Origin.

    Invasive disease-free survival (iDFS, excluding second primary invasive cancers of non-breast origin) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS excluding second primary invasive cancers of non-breast origin is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, or death from any cause. Second primary invasive cancers of non-breast origin will not be considered as events for this endpoint. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported.

    Measured: 4 years

  2. Distant Recurrence-free Survival (DRFS)

    Compare time to distant recurrence-free survival (DRFS). Distant recurrence is defined according to STEEP criteria as the time from randomization to the date of the first event: distant recurrence or death from any cause. Patients with a locoregional recurrence will continue to be followed for DRFS. Surviving patients who are event-free will be censored at: the date of last disease assessment, or withdrawal of consent to be followed, or death whichever came first. Direct comparison between arms used time to DRFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered DRFS at 4 years is reported.

    Measured: 4 years

  3. Overall Survival (OS)

    Compare overall survival (OS). Overall survival is defined as the time period between randomization and death. Surviving patients classified as lost-to-follow up or having withdrawn consent to be followed will be censored at their date of last contact or withdrawal of consent to be followed, whichever occurs first.

    Measured: 4 years

  4. Locoregional Recurrences-free Survival (LRRFS)

    Compare locoregional recurrence-free survival (LRRFS). LRRFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, or death from any cause. Patients with second primary invasive cancers of non-breast origin or distant recurrence will be censored at the date of diagnosis. Surviving patients who are event-free will be censored at: the date of last disease assessment, or withdrawal of consent to be followed, whichever occurs first.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionNov 2020
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5,796 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02513394
Sponsor's protocol ID
AFT-05
Other IDs
ABCSG 42, BIG 14-03, 2014-005181-30, 2014
Acronym
PALLAS
Status last verified
Jun 2026
First submitted
29 Jul 2015
Last updated
15 Jun 2026
Data monitoring committee
Yes

Publications

  • Shinn E, Zahrieh D, DeMichele A, Zdenkowski N, Lemieux J, Mao J, Bjelic-Radisic V, Naughton MJ, Pfeiler G, Gelmon K, Balko JM, Egle D, Zoppoli G, Traina T, Jimenez MM, Novoa SA, Haddad T, Chan A, Ring A, Wolff A, Symmans WF, Ponce Lorenzo J, Sabanathan D, Burstein HJ, Nowecki ZI, Pristauz-Telsnigg G, Brufsky A, Bellet-Ezquerra M, Foukakis T, Novik Y, Rubovszky G, Singer CF, Muehlbacher K, Filho OM, Goulioti T, Law E, Partridge AH, Carey LA, Zoroufy A, Hlauschek D, Fesl C, Mayer EL, Gnant M. Impact of adding palbociclib on treatment adherence to ongoing adjuvant endocrine treatment in the global randomized PALLAS randomized trial in patients with early breast cancer. Breast Cancer Res Treat. 2025 Jun;211(2):385-397. doi: 10.1007/s10549-025-07653-2. Epub 2025 Mar 27.

    PubMed 40140172

  • DeMichele A, Dueck AC, Hlauschek D, Martin M, Burstein H, Pfeiler G, Zdenkowski N, Wolff A, Bellet-Ezquerra M, Winer E, Balic M, Miller K, Colleoni M, Lake D, Rubovsky G, Cameron D, Balko J, Singer CF, Nowecki Z, Iwata H, Wolmark N, Parraga KA, Rugo H, Steger GG, Traina T, Werutsky G, Czajkowska D, Metzger O, El-Abed S, Theall KP, Lu RD, O'Brien P, Fesl C, Mayer E, Gnant M. Outcomes in stage IIA versus stage IIB/III in the PALLAS trial [ABCSG-42/AFT-05/PrE0109/BIG-14-13]). Breast Cancer Res. 2025 Jan 23;27(1):12. doi: 10.1186/s13058-024-01941-3.

    PubMed 39849600

  • Pfeiler G, Hlauschek D, Mayer EL, Deutschmann C, Kacerovsky-Strobl S, Martin M, Meisel JL, Zdenkowski N, Loibl S, Balic M, Park H, Prat A, Isaacs C, Bajetta E, Balko JM, Bellet-Ezquerra M, Bliss J, Burstein H, Cardoso F, Fohler H, Foukakis T, Gelmon KA, Goetz M, Haddad TC, Iwata H, Jassem J, Lee SC, Linderholm B, Los M, Mamounas EP, Miller KD, Morris PG, Munzone E, Gal-Yam EN, Ring A, Shepherd L, Singer C, Thomssen C, Tseng LM, Valagussa P, Winer EP, Wolff AC, Zoppoli G, Machacek-Link J, Schurmans C, Huang X, Gauthier E, Fesl C, Dueck AC, DeMichele A, Gnant M; PALLAS Groups and Investigators. Impact of BMI in Patients With Early Hormone Receptor-Positive Breast Cancer Receiving Endocrine Therapy With or Without Palbociclib in the PALLAS Trial. J Clin Oncol. 2023 Nov 20;41(33):5118-5130. doi: 10.1200/JCO.23.00126. Epub 2023 Aug 9.

    PubMed 37556775

  • Mayer EL, Fesl C, Hlauschek D, Garcia-Estevez L, Burstein HJ, Zdenkowski N, Wette V, Miller KD, Balic M, Mayer IA, Cameron D, Winer EP, Ponce Lorenzo JJ, Lake D, Pristauz-Telsnigg G, Haddad TC, Shepherd L, Iwata H, Goetz M, Cardoso F, Traina TA, Sabanathan D, Breitenstein U, Ackerl K, Metzger Filho O, Zehetner K, Solomon K, El-Abed S, Theall KP, Lu DR, Dueck A, Gnant M, DeMichele A. Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03). J Clin Oncol. 2022 Feb 10;40(5):449-458. doi: 10.1200/JCO.21.01918. Epub 2022 Jan 7.

    PubMed 34995105

  • Gnant M, Dueck AC, Frantal S, Martin M, Burstein HJ, Greil R, Fox P, Wolff AC, Chan A, Winer EP, Pfeiler G, Miller KD, Colleoni M, Suga JM, Rubovsky G, Bliss JM, Mayer IA, Singer CF, Nowecki Z, Hahn O, Thomson J, Wolmark N, Amillano K, Rugo HS, Steger GG, Hernando Fernandez de Aranguiz B, Haddad TC, Perello A, Bellet M, Fohler H, Metzger Filho O, Jallitsch-Halper A, Solomon K, Schurmans C, Theall KP, Lu DR, Tenner K, Fesl C, DeMichele A, Mayer EL; PALLAS groups and investigators. Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03). J Clin Oncol. 2022 Jan 20;40(3):282-293. doi: 10.1200/JCO.21.02554. Epub 2021 Dec 7.

    PubMed 34874182

  • Mayer EL, Dueck AC, Martin M, Rubovszky G, Burstein HJ, Bellet-Ezquerra M, Miller KD, Zdenkowski N, Winer EP, Pfeiler G, Goetz M, Ruiz-Borrego M, Anderson D, Nowecki Z, Loibl S, Moulder S, Ring A, Fitzal F, Traina T, Chan A, Rugo HS, Lemieux J, Henao F, Lyss A, Antolin Novoa S, Wolff AC, Vetter M, Egle D, Morris PG, Mamounas EP, Gil-Gil MJ, Prat A, Fohler H, Metzger Filho O, Schwarz M, DuFrane C, Fumagalli D, Theall KP, Lu DR, Bartlett CH, Koehler M, Fesl C, DeMichele A, Gnant M. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2021 Feb;22(2):212-222. doi: 10.1016/S1470-2045(20)30642-2. Epub 2021 Jan 15.

    PubMed 33460574

  • Dieras V, Rugo HS, Schnell P, Gelmon K, Cristofanilli M, Loi S, Colleoni M, Lu DR, Mori A, Gauthier E, Huang Bartlett C, Slamon DJ, Turner NC, Finn RS. Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer. J Natl Cancer Inst. 2019 Apr 1;111(4):419-430. doi: 10.1093/jnci/djy109.

    PubMed 30032196

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Palbociclib and Standard Adjuvant Endocrine Therapy in people with Breast Cancer, run by Alliance Foundation Trials, LLC. at 437 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 437 sites in United States, Spain, Germany, Austria, Australia and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive Disease Free Survival (iDFS) (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02513394, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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PALbociclib CoLlaborative Adjuvant Study (NCT02513394) | AzTrials