Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
5796 participants
INTERVENTIONAL
2015-08-31
2028-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Palbociclib 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.
Palbociclib
Standard Adjuvant Endocrine Therapy
Arm B
Standard adjuvant endocrine therapy for a duration of at least 5 years.
Standard Adjuvant Endocrine Therapy
Interventions
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Palbociclib
Standard Adjuvant Endocrine Therapy
Eligibility Criteria
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Inclusion Criteria
* 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.
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.
Exclusion Criteria
* 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.
* 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).
18 Years
ALL
No
Sponsors
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Austrian Breast & Colorectal Cancer Study Group
NETWORK
NSABP Foundation Inc
NETWORK
PrECOG, LLC.
OTHER
Breast International Group
OTHER
Pfizer
INDUSTRY
Alliance Foundation Trials, LLC.
OTHER
Responsible Party
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Principal Investigators
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Evanthia Galanis, MD
Role: PRINCIPAL_INVESTIGATOR
Alliance Foundation Trials, LLC.
Erica Mayer, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Angela DeMichele, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Michael Gnant, MD
Role: PRINCIPAL_INVESTIGATOR
ABCSG, Medical University Vienna
Locations
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Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Southern Cancer Center PC - Providence
Mobile, Alabama, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Cancer Center
Anchorage, Alaska, United States
Mayo Clinic in Arizona
Phoenix, Arizona, United States
Kaiser Permanente Anaheim Medical Center
Anaheim, California, United States
Kaiser Permanente Baldwin Park Medical Center
Baldwin Park, California, United States
Kaiser Permanente Bellflower Medical Center
Bellflower, California, United States
Kaiser Permanente Fontana Medical Center
Fontana, California, United States
Marin Cancer Care
Greenbrae, California, United States
Marin Cancer Center
Greenbrae, California, United States
Kaiser Permanente Harbor City Medical Center
Harbor City, California, United States
Kaiser Permanente Irvine Medical Center
Irvine, California, United States
UCSD Moores Cancer Center
La Jolla, California, United States
Long Beach Memorial Medical Center - Todd Cancer Institute
Long Beach, California, United States
Kaiser Permanente Sunset Medical Center
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Kaiser Permanente Oakland Medical Center
Oakland, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Kaiser Permanente Panorama City Medical Center
Panorama City, California, United States
Kaiser Permanente Riverside Medical Center
Riverside, California, United States
Kaiser Permanente Roseville Medical Center
Roseville, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
University of California
San Diego, California, United States
Kaiser Permanente San Diego Medical Center
San Diego, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Kaiser Permanente San Francisco Medical Center
San Francisco, California, United States
UCSF Helen Diller Comprehensive Cancer Center
San Francisco, California, United States
Kaiser Permanente San Jose Medical Center
San Jose, California, United States
Kaiser Permanente San Leandro Medical Center
San Leandro, California, United States
Kaiser Permanente San Marcos Medical Center
San Marcos, California, United States
Kaiser Permanente Santa Clara Medical Center
Santa Clara, California, United States
Kaiser Permanente South San Francisco Medical Center
South San Francisco, California, United States
Stanford Women's Cancer Center
Stanford, California, United States
Kaiser Permanente Vallejo Medical Center
Vallejo, California, United States
Kaiser Permanente Walnut Creek Medical Center
Walnut Creek, California, United States
Kaiser Permanente Cadillac Medical Center
West Los Angeles, California, United States
Kaiser Permanente Woodland Hills Medical Center
Woodland Hills, California, United States
Western States Cancer Research NCORP
Denver, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Memorial Sloan Cancer Center - Hartford Healthcare Center Institute at HOCC
New Britain, Connecticut, United States
Christiana Health System - Christiana Hospital
Newark, Delaware, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
University of Miami Miller School of Medicine Sylvester Cancer Center
Miami, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Phoebe Putney Memorial Hospital
Albany, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago Cancer Center LAPS
Chicago, Illinois, United States
Cancer Care Specialist of Central Illinois
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
NorthShore University Health System - Evanston Hospital
Evanston, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Joliet Oncology Hematology Associates Limited
Joliet, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
OSF Saint Anthony Medical Center
Rockford, Illinois, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, United States
NorthShore Hematology Oncology-Libertyville
Skokie, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Indiana University - Melvin and Bren Simon Cancer Center LAPS
Indianapolis, Indiana, United States
IU Health Ball Memorial Hospital
Muncie, Indiana, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States
McFarland Clinic, P.C.
Ames, Iowa, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, United States
Iowa Oncology Research Assoc
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates - Des Moines
Des Moines, Iowa, United States
Covenant Medical Center
Waterloo, Iowa, United States
University of Kentucky-Markey Cancer Center
Lexington, Kentucky, United States
Norton Cancer Institute - Brownsboro
Louisville, Kentucky, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Eastern Maine Medical Center d/b/a Northern Light Cancer Institute
Bangor, Maine, United States
New England Cancer Specialists - Scarborough
Scarborough, Maine, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
Mercy Medical Center
Baltimore, Maryland, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
MedStar Good Samaritan Hospital
Baltimore, Maryland, United States
MedStar Franklin Square Medical Center Winberg Cancer Institute
Baltimore, Maryland, United States
Medstar Union Memorial Hospital
Baltimore, Maryland, United States
JHU Sidney Kimmel Comprehensive Cancer Center LAPS
Baltimore, Maryland, United States
Frederick Regional Health System James M Stockman Cancer Institute
Baltimore, Maryland, United States
Maryland Oncology Hematology PA
Bethesda, Maryland, United States
Tidal Health Peninsula Regional
Salisbury, Maryland, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lowell General Hospital
Lowell, Massachusetts, United States
Beth Israel Deaconess Hospital - Plymouth Jordan Club Cancer Center
Plymouth, Massachusetts, United States
Spectrum Health Butterworth Research Pharmacy
Grand Rapids, Michigan, United States
Trinity Health Michigan
Livonia, Michigan, United States
Essentia Health NCORP
Duluth, Minnesota, United States
Mayo Clinic-Rochester
Rochester, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
Metro Minnesota Oncology Research Consortium
Saint Louis Park, Minnesota, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Phelps Country Regional Medical Center
Rolla, Missouri, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Nebraska Hematology and Oncology
Lincoln, Nebraska, United States
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States
Cancer Alliance of Nebraska
Omaha, Nebraska, United States
Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
New Hampshire Oncology-Hematology PA, Concord
Concord, New Hampshire, United States
New Hampshire Oncology-Hematology PA
Hooksett, New Hampshire, United States
Solinsky Center for Cancer Care
Hooksett, New Hampshire, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Norris Cotton Cancer Center - Nashua
Lebanon, New Hampshire, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Rutgers Cancer Center Institute of New Jersey
New Brunswick, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Mary Imogene Bassett Hospital
Cooperstown, New York, United States
Hematology Oncology Associates of Central New York - East Syracuse
East Syracuse, New York, United States
Queens Hospital Center
Jamaica, New York, United States
Northwell Health NCORP
New Hyde Park, New York, United States
Beth Israel Medical Center - New York
New York, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Memorial Sloan Kettering Cancer Center - LAPS
New York, New York, United States
Oneonta FoxCare Center
Oneonta, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center - Einstein Campus
The Bronx, New York, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
The Charlotte-Mecklenburg Hospital Authority
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Kinston Medical Specialists, PA
Kinston, North Carolina, United States
First Health of the Carolinas - Moore Regional Hospital
Pinehurst, North Carolina, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Cleveland Clinic Cancer Center/Hillcrest Hospital
Mayfield Heights, Ohio, United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Providence Portland Medical Center
Portland, Oregon, United States
Hematology & Oncology Associates of Northeastern PA
Dunmore, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC MaGee Women's Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute- Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Reading Hospital/McGlinn Cancer Institute
Wyomissing, Pennsylvania, United States
WellSpan Health York Cancer Center
York, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Lexington Medical Center/Lexington Oncology Associates
Columbia, South Carolina, United States
Avera Cancer Institute-Aberdeen
Aberdeen, South Dakota, United States
Monument Health Rapid City Hospital
Rapid City, South Dakota, United States
Rapid City Regional Hospital/Regional Cancer Care Institute
Rapid City, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Nashville General Hospital at Meharry
Nashville, Tennessee, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Houston Methodist Hospital Cancer Center
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Doctors Hospital of Laredo
Laredo, Texas, United States
Huntsman Cancer Institute - University of Utah
Salt Lake City, Utah, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
VCU Massey Cancer Center
Richmond, Virginia, United States
CAMC Cancer Center
Charleston, West Virginia, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States
HSHS Saint Vincent Hospital
Green Bay, Wisconsin, United States
Gunderson Lutheran Medical Center
La Crosse, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Wheaton Franciscan Healthcare - St. Joseph
Milwaukee, Wisconsin, United States
Columbia St. Mary's Water Tower Medical Commons
Milwaukee, Wisconsin, United States
Wheaton Franciscan Healthcare-All Saints
Racine, Wisconsin, United States
Orchard Healthcare Research Inc.
Waukesha, Wisconsin, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States
Wheaton Franciscan Healthcare - Wauwatosa
Wauwatosa, Wisconsin, United States
Southern Highlands Cancer Centre
Bowral, New South Wales, Australia
Coffs Harbour Health Campus - MNCCI
Coffs Harbour, New South Wales, Australia
The Breast & Endocrine Centre
Gateshead, New South Wales, Australia
Gosford Hospital
Gosford, New South Wales, Australia
Macquarie University Hospital
Macquarie Park, New South Wales, Australia
Orange Health Service
Orange, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Royal Brisbane & Women's Hospital
Brisbane, Queensland, Australia
Flinders Drive
Bedford Park, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
The Northern Hospital
Epping, Victoria, Australia
St Vincent's Hospital
Fitzroy, Victoria, Australia
Peninsula Health - Frankston Hospital
Frankston, Victoria, Australia
University Hospital, Geelong
Geelong, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Peninsula Health - Frankston Hospital
Melbourne, Victoria, Australia
Western Health, Sunshine Hospital
St Albans, Victoria, Australia
South West Healthcare, Warrnambool
Warrnambool, Victoria, Australia
St John of God Bunbury Hospital
Bunbury, Western Australia, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Breast Cancer Research Centre - WA
Nedlands, Western Australia, Australia
LKH Feldkirch, Department of Internal Medicine
Feldkirch, , Austria
LKH Univ Klinikum Graz, Dept of Internal Med. and Oncology
Graz, , Austria
Medical University of Graz, Gyn. Dept.
Graz, , Austria
University Hospital Innsbruck, Department of Obstetrics and Gynaecology
Innsbruck, , Austria
BKH Kufstein, Innere Medizin
Kufstein, , Austria
LKH Hochsteiermark Leoben
Leoben, , Austria
Hospital of the Sisters of Charity Linz, Surg. Dept., Breast Health Center
Linz, , Austria
Kepler Universitätsklinikum Med. Campus III
Linz, , Austria
Weinviertelklinikum Mistelbach, Department of Surgery
Mistelbach, , Austria
BHS Ried, Abt. f. Gynäkologie
Ried, , Austria
LKH Salzburg, Univ. Klinik f. Innere Med. III
Salzburg, , Austria
Universitätsklinikum St. Pölten, Innere Medizin
Sankt Pölten, , Austria
Breast Centre Dr. Wette Viktor
Sankt Veit an der Glan, , Austria
Phyrn-Eisenwurzen Klinikum Steyr
Steyr, , Austria
Medical University of Vienna Department of Obstetrics and Gynaecology
Vienna, , Austria
Medical University Vienna - Coop Group Surgery/Oncology
Vienna, , Austria
Hospital Hietzing, Gynecology
Vienna, , Austria
St. Josef Krankenhaus, Department of Internal I
Vienna, , Austria
Klinik Ottakring
Vienna, , Austria
Salzkammergut-Klinikum Vöcklabruck
Vöcklabruck, , Austria
Brustordination Dr. Thiel
Weiz, , Austria
Klinikum Wels - Grieskirchen GmbH, Department of Internal Medicine IV
Wels, , Austria
Landesklinikum Wr. Neustadt, Department of Surgery
Wiener Neustadt, , Austria
LKH Wolfsberg, Department of Surgery
Wolfsberg, , Austria
OLV ziekenhuis Aalst/Radiotherapy-Oncology
Aalst, , Belgium
CHU Saint Pierre/Medical Oncology
Brussels, , Belgium
Institut Jules Bordet/Medical Oncology Department
Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Oncologisch centrum
Brussels, , Belgium
Grand Hopital de Charleroi - Oncologie-hématologie
Charleroi, , Belgium
University Hospital Antwerp (UZA)
Edegem, , Belgium
UZ Leuven/ Gynaecologie-Oncologie
Leuven, , Belgium
CHC - Saint-Joseph/Oncology-Hematology
Liège, , Belgium
CHU Sart Tilman Liège (Medical Oncology)
Liège, , Belgium
Clinique et Maternite Sainte-Elisabeth - Oncology Department
Namur, , Belgium
CHR - Centre Hospitalier Peltzer La Tourelle/ Oncology Department
Verviers, , Belgium
GZA Ziekenhuizen (Campus Sint-Augustinus) / Oncologische Centrum
Wilrijk, , Belgium
Tom Baker Cancer Centre - Dept. of Oncology
Calgary, Alberta, Canada
BC Cancer Agency- Abbotsford Centre
Abbotsford, British Columbia, Canada
BC Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
Kelowna, British Columbia, Canada
BC Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
CancerCare Manitoba - St. Boniface Hospital
Winnipeg, Manitoba, Canada
The Vitalite Health Network - Dr. Leon Richard
Moncton, New Brunswick, Canada
Horizon Health Network - Saint John Regional Hospital
Saint John, New Brunswick, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Kingston General Hospital, Cancer Centre of Southeastern Ontario/Oncology
Kingston, Ontario, Canada
Grand River Regional Cancer Center
Kitchener, Ontario, Canada
Niagara Health System
St. Catharines, Ontario, Canada
Sunnybrook
Toronto, Ontario, Canada
University Health Network Princess Margaret Cancer Centre
Toronto, Ontario, Canada
The Jewish General Hospital
Montreal, Quebec, Canada
CHUM Hôtel Dieu
Montreal, Quebec, Canada
CHU de Québec - Hôpital du St Sacrement
Québec, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Center, University of Saskatchewan
Saskatoon, Saskatchewan, Canada
University Hospital Aachen
Aachen, , Germany
Praxisklinik Krebsheilkunde für Frauen
Berlin, , Germany
Helios Klinikum Berlin-Buch
Berlin, , Germany
Studienzentrum City
Berlin, , Germany
Marienhospital Bottrop, Klinik für Gynäkologie und Geburtshilfe
Bottrop, , Germany
Studien GbR Braunschweig, Lorenz&HeckerWesche
Braunschweig, , Germany
Praxis und Tagesklinik für gynäkologische Onkologie,
Ebersberg, , Germany
MVZ Eggenfelden
Eggenfelden, , Germany
Frauenklinik/University Hospital Erlangen
Erlangen, , Germany
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt, , Germany
Agaplesion Markus Krankenhaus
Frankfurt, , Germany
Klinikum Frankfurt Höchst
Frankfurt, , Germany
Onkol. GP Dres. med. Wilke/Wagner/Petzoldt
Fürth, , Germany
Universitätsfrauenklinik Halle (Saale)
Halle, , Germany
University Medical Center Hamburg-Eppendorf, Department of Gynecology
Hamburg, , Germany
Albertinen Krankenhaus
Hamburg, , Germany
Städtisches Klinikum Karlsruhe
Karlsruhe, , Germany
Elisabeth Krankenhaus Kassel Brustzentrum
Kassel, , Germany
St. Elisabeth Krankenhaus Leipzig
Leipzig, , Germany
St. Vincenz KH Limburg Frauenklinik
Limburg, , Germany
UKSH Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe
Lübeck, , Germany
Universitätsmedizin Mainz
Mainz, , Germany
Praxis Gynäkologie Arabella
München, , Germany
University Clinic Oldenburg
Oldenburg, , Germany
Oncologianova GmbH
Recklinghausen, , Germany
HELIOS Klinik Rottweil - Gynäkologie
Rottweil, , Germany
St. Josefs-Hospital
Wiesbaden, , Germany
Országos Onkológiai Intézet - "B" Belgyógyászati Onkológiai és Klinikai Farmakológiai Osztály
Budapest, , Hungary
Uzsoki Utcai Kórház - Onkoradiológia, Sugárterápia, Fővárosi Onkoradiológiai Központ
Budapest, , Hungary
University of Debrecen Medical Center, Clinic of Oncology
Debrecen, , Hungary
Petz Aladár Megyei Oktatókórház - Onkoradiológiai Osztály
Győr, , Hungary
Szegedi Tudomanyegyetem Általános Orvostudományi Kar Szent-Györgyi Albert Klinikai Központ, Onkoterápiás Klinika
Szeged, , Hungary
Bon Secours Hospital, Cork
Cork, , Ireland
Cork University Hospital, Oncology Clinical Trials Unit
Cork, , Ireland
Beaumont Hospital - Cancer Clinical Trials Unit
Dublin, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
St James's Hospital, Cancer Clinical Trials Office, Old Admin Building,
Dublin, , Ireland
St Vincent Hospital - Medical Oncology Research Department
Dublin, , Ireland
University Hospital Limerick, Midwestern Cancer Centre
Limerick, , Ireland
Sligo University Hospital
Sligo, , Ireland
University Hospital Waterford, Cancer Research Department
Waterford, , Ireland
Rabin Medical Center (RMC)
Petah Tikva, Central District, Israel
Sheba Medical Center Tel Hashomer
Ramat Gan, Tel Aviv, Israel
Sourasky Medical Center
Tel Aviv, , Israel
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, , Italy
Azienda Ospedaliero-Universitaria Careggi/Florence University/Radiation Oncology Unit
Florence, , Italy
Department of Internal Medicine (DIMI) - IRCCS San Martino University Hospital
Genoa, , Italy
P.O. Misericordia AUSL Toscana Sud Est
Grosseto, , Italy
Ospedale "Mater Salutis" di Legnago, Dept. of Medical Oncology
Legnago, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) IRCCS
Meldola, , Italy
Ospedale San Raffaele
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Policlinico di Monza - Istituto di Oncologia del Policlinico di Monza
Monza, , Italy
Medical Oncology Unit; University Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)
Parma, , Italy
Nuovo Ospedale di Prato (NOP) - Azienda USL4 Prato
Prato, , Italy
ASST Bergamo Ovest
Treviglio, , Italy
S. Anna Hospital (Ospedale Sant'Anna)- Turin
Turin, , Italy
Nagoya City University Hospital/Dept. of Breast & Endocrine Surgery
Nagoya, Aichi-ken, Japan
Department of Breast Surgery National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Chiba Cancer Center
Chiba, , Japan
Kyoto University Hospital/Breast Surgery
Kyoto, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Centro Médico Zambrano Hellion
Monterrey, Nuevo León, Mexico
Centro Oncológico Estatal ISSEMYM
Toluca, Toluca, Mexico
National Cancer Institute Mexico, Breast Cancer Department
Mexico City, , Mexico
Máxima Medisch Centrum
Eindhoven, , Netherlands
Zuyderland Ziekenhuis, Oncology
Geleen, , Netherlands
St Antonius Hospital
Nieuwegein, , Netherlands
Hagaziekenhuis
The Hague, , Netherlands
Zaans Medical Center
Zaandam, , Netherlands
Isala, Dept of Medical Oncology
Zwolle, , Netherlands
Uniwersyteckie Centrum Kliniczne (UCK), Klinika Onkologii I Radioterapii
Gdansk, , Poland
Instytut MSF Spółka z ograniczoną odpowiedzialnością
Lodz, , Poland
Opolskie Centrum Onkologii, Oddzial Onkologii Klinicznej
Opole, , Poland
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
Warsaw, , Poland
Instituto Português de Oncologia (IPO) de Lisboa Francisco Gentil
Lisbon, , Portugal
Centro Clinico Champalimaud
Lisbon, , Portugal
Hospital da Luz
Lisbon, , Portugal
CUF Descobertas Hospital, Hemato-Oncologia
Lisbon, , Portugal
Instituto Português de Oncologia (IPO) Francisco Gentil do Porto
Porto, , Portugal
Seoul National University Hospital, Hematology-Medical Oncology
Seoul, , South Korea
Severance Hospital Medical Doctor at Department of Medical Oncology
Seoul, , South Korea
Samsung Medical Centre, Breast Cancer Center, Department of Medicine, Division of Hematology/Oncology
Seoul, , South Korea
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, , Spain
Centro Oncologico de Galicia
A Coruña, , Spain
Hospital General Universitario Alicante
Alicante, , Spain
ICO Badalona
Badalona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Quirón Dexeus
Barcelona, , Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Hospital General de Granollers
Barcelona, , Spain
Instituto Catalán de Oncología (ICO) de L'Hospitalet de Llobregat
Barcelona, , Spain
Hospital Vall d´Hebron
Barcelona, , Spain
Hospital Universitario de Burgos
Burgos, , Spain
Consorcio Hospitalario Provincial de Castellon
Castellon, , Spain
San Pedro de Alcántara
Cáceres, , Spain
Hospital Reina Sofía
Córdoba, , Spain
Hospital General Universitario de Elche
Elche, , Spain
ICO/ H. Josep Trueta
Girona, , Spain
Complejo asistencial universitario de Leon
León, , Spain
Hospital Universitario Gregorio Marañón
Madrid, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital La Paz, Servicio de Oncologia Médica
Madrid, , Spain
CIOCC - Centro Integral Oncológico Clara Campal / Hospital HM Universitario Sanchinarro
Madrid, , Spain
Hospital Puerta de Hierro Majadahonda, Oncologia Médica
Madrid, , Spain
Hospital Universitario Fundacion Alcorcón
Madrid, , Spain
Hospital Clínico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital General Universitario José Mª Morales Meseguer
Murcia, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospitali Universitari son Espases
Palma, , Spain
Hospital Son Llatzer
Palma, , Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
Hospital Universitari Sant Joan de Reus
Reus, , Spain
Hospital Universitario Donostia
San Sebastián, , Spain
Hospital de Sant Juan Despi Moisés Broggi
Sant Joan Despì, , Spain
Hospital Clinico Universitario de Santiago
Santiago, , Spain
Hospital Unversitario Virgen Macarena
Seville, , Spain
Hospital Quirón Sagrado Corazón
Seville, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Consorci Sanitari de Terrassa
Terrassa, , Spain
Hospital Virgen de la Salud
Toledo, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hosital Arnau de Vilanova Valencia
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Gävle Hospital, Dept. of Oncology
Gävle, , Sweden
Sahlgrenska University Hospital, Dept. Oncology
Gothenburg, , Sweden
Universitetssjukhuset Örebro (University Hospital) Örebro, Onkologkliniken
Örebro, , Sweden
Karolinska Universitetssjukhuset, Bröstcentrum A2:00
Stockholm, , Sweden
Akademiska Sjukhuset Uppsala (University Hospital), Onkologkliniken
Uppsala, , Sweden
Kantonspital Baden
Baden, Canton of Aargau, Switzerland
Spital STS AG, Onkologiezentrum Thun-Berner Oberland
Thun, Canton of Bern, Switzerland
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, Switzerland
IOSI-Breast Cancer Unit-Ospedale San Giovanni-Bellinzona
Bellinzona, Canton Ticino, Switzerland
Fondazione Oncologia Lago Maggiore, Locarno
Locarno, Canton Ticino, Switzerland
Kantonsspital Graubünden
Chur, Kanton Graubünden, Switzerland
Dep. Oncology, University Hospital
Basel, , Switzerland
HFR Fribourg, Oncology Department
Fribourg, , Switzerland
Luzerner Kantonsspital, Dept. of Medical Oncology
Lucerne, , Switzerland
Onkologisches Forschungszentrum Klinik St. Anna, Hirslanden
Lucerne, , Switzerland
Kantonsspital St.Gallen, Onkologie/Hämatologie
Sankt Gallen, , Switzerland
Brust-Zentrum Zürich
Zurich, , Switzerland
Universitätsspital Zürich, Klinik für Onkologie
Zurich, , Switzerland
Changhua Christian Hospital/General Surgery
Changhua, Changhua County, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital, Division of Hemato-Oncology, Dept. Internal Medicine
Tainan City, , Taiwan
National Taiwan University Hospital/Department of Surgery
Taipei, , Taiwan
Taipei Veterans General Hospital/General Surgery
Taipei, , Taiwan
City Hospital Birmingham
Birmingham, , United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, , United Kingdom
Velindre Cancer Centre
Cardiff, , United Kingdom
Royal Marsden Hospital Chelsea
Chelsea, , United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
University Hospitals of Leicester
Leicester, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
The Royal Marsden Sutton
London, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Maidstone Hospital, Kent Oncology Centre
Maidstone, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Northern Centre for Cancer Care
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospitals NHS TRUST UK
Nottingham, , United Kingdom
Weston Park Hospital, Sheffield Teaching Hospitals
Sheffield, , United Kingdom
Royal Cornwall Hospitals NHS Trust, Oncology Trials, Sunrise Centre
Truro, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ABCSG 42
Identifier Type: OTHER
Identifier Source: secondary_id
BIG 14-03
Identifier Type: OTHER
Identifier Source: secondary_id
2014-005181-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AFT-05
Identifier Type: -
Identifier Source: org_study_id
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