PALbociclib CoLlaborative Adjuvant Study (PALLAS)

January 22, 2024 updated by: Alliance Foundation Trials, LLC.

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.

Study Overview

Status

Active, not recruiting

Conditions

Breast Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5796

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Bowral, New South Wales, Australia, 2576
    - Southern Highlands Cancer Centre
  - Coffs Harbour, New South Wales, Australia, 2450
    - Coffs Harbour Health Campus - MNCCI
  - Gateshead, New South Wales, Australia, 2290
    - The Breast & Endocrine Centre
  - Gosford, New South Wales, Australia, 2500
    - Gosford Hospital
  - Macquarie Park, New South Wales, Australia, 2109
    - Macquarie University Hospital
  - Orange, New South Wales, Australia, 2800
    - Orange Health Service
  - Wollongong, New South Wales, Australia, 2500
    - Wollongong Hospital
- Queensland
  - Brisbane, Queensland, Australia, 4029
    - Royal Brisbane & Women's Hospital
- South Australia
  - Bedford Park, South Australia, Australia, 5042
    - Flinders Drive
- Tasmania
  - Hobart, Tasmania, Australia, 7000
    - Royal Hobart Hospital
- Victoria
  - Epping, Victoria, Australia, 3076
    - The Northern Hospital
  - Fitzroy, Victoria, Australia, 3065
    - St Vincent's hospital
  - Frankston, Victoria, Australia, 3199
    - Peninsula Health - Frankston Hospital
  - Geelong, Victoria, Australia, 3220
    - University Hospital, Geelong
  - Melbourne, Victoria, Australia, 3000
    - Peter MacCallum Cancer Centre
  - Melbourne, Victoria, Australia
    - Peninsula Health - Frankston Hospital
  - St. Albans, Victoria, Australia, 3021
    - Western Health, Sunshine Hospital
  - Warrnambool, Victoria, Australia, 3280
    - South West Healthcare, Warrnambool
- Western Australia
  - Bunbury, Western Australia, Australia, 6231
    - St John of God Bunbury Hospital
  - Murdoch, Western Australia, Australia
    - Fiona Stanley Hospital
  - Nedlands, Western Australia, Australia, 6009
    - Breast Cancer Research Centre - WA
Austria
- - Feldkirch, Austria, 6807
    - LKH Feldkirch, Department of Internal Medicine
  - Graz, Austria, 8036
    - LKH Univ Klinikum Graz, Dept of Internal Med. and Oncology
  - Graz, Austria, 8036
    - Medical University of Graz, Gyn. Dept.
  - Innsbruck, Austria, 6020
    - University Hospital Innsbruck, Department of Obstetrics and Gynaecology
  - Kufstein, Austria, 6330
    - BKH Kufstein, Innere Medizin
  - Leoben, Austria, 8700
    - LKH Hochsteiermark Leoben
  - Linz, Austria, 4010
    - Hospital of the Sisters of Charity Linz, Surg. Dept., Breast Health Center
  - Linz, Austria, 4020
    - Kepler Universitätsklinikum Med. Campus III
  - Mistelbach, Austria, 2130
    - Weinviertelklinikum Mistelbach, Department of Surgery
  - Ried, Austria, 4910
    - BHS Ried, Abt. f. Gynäkologie
  - Salzburg, Austria, 5020
    - LKH Salzburg, Univ. Klinik f. Innere Med. III
  - St. Pölten, Austria, 3100
    - Universitätsklinikum St. Pölten, Innere Medizin
  - St. Veit an der Glan, Austria, 9300
    - Breast Centre Dr. Wette Viktor
  - Steyr, Austria, 4400
    - Phyrn-Eisenwurzen Klinikum Steyr
  - Vienna, Austria, 1160
    - Klinik Ottakring
  - Vienna, Austria, 1090
    - Medical University of Vienna Department of Obstetrics and Gynaecology
  - Vienna, Austria, 1090
    - Medical University Vienna - Coop Group Surgery/Oncology
  - Vienna, Austria, 1130
    - Hospital Hietzing, Gynecology
  - Vienna, Austria, 1130
    - St. Josef Krankenhaus, Department of Internal I
  - Voecklabruck, Austria, 4840
    - Salzkammergut-Klinikum Vöcklabruck
  - Weiz, Austria, 8160
    - Brustordination Dr. Thiel
  - Wels, Austria, 4600
    - Klinikum Wels - Grieskirchen GmbH, Department of Internal Medicine IV
  - Wolfsberg, Austria, 9400
    - LKH Wolfsberg, Department of Surgery
  - Wr. Neustadt, Austria, 2700
    - Landesklinikum Wr. Neustadt, Department of Surgery
Belgium
- - Aalst, Belgium, 9300
    - OLV ziekenhuis Aalst/Radiotherapy-Oncology
  - Brussels, Belgium, 1000
    - CHU Saint Pierre/Medical Oncology
  - Brussels, Belgium, 1000
    - Institut Jules Bordet/Medical Oncology Department
  - Bruxelles, Belgium, 1200
    - Cliniques Universitaires Saint-Luc, Oncologisch centrum
  - Charleroi, Belgium, 6000
    - Grand Hopital de Charleroi - Oncologie-hématologie
  - Edegem, Belgium, 2650
    - University Hospital Antwerp (UZA)
  - Leuven, Belgium, 3000
    - UZ Leuven/ Gynaecologie-Oncologie
  - Liège, Belgium, 4000
    - CHC - Saint-Joseph/Oncology-Hematology
  - Liège, Belgium, 4000
    - CHU Sart Tilman Liège (Medical Oncology)
  - Namur, Belgium, 5000
    - Clinique et Maternite Sainte-Elisabeth - Oncology Department
  - Verviers, Belgium, 4800
    - CHR - Centre Hospitalier Peltzer La Tourelle/ Oncology Department
  - Wilrijk, Belgium, 2610
    - GZA Ziekenhuizen (Campus Sint-Augustinus) / Oncologische Centrum
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N4N2
    - Tom Baker Cancer Centre - Dept. of Oncology
- British Columbia
  - Abbotsford, British Columbia, Canada, V2S0C2
    - BC Cancer Agency- Abbotsford Centre
  - Kelowna, British Columbia, Canada, V1Y5L3
    - BC Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
  - Vancouver, British Columbia, Canada, V5Z4E6
    - BC Cancer Agency - Vancouver Cancer Centre
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H2A6
    - CancerCare Manitoba - St. Boniface Hospital
- New Brunswick
  - Moncton, New Brunswick, Canada, E1C8X3
    - The Vitalite Health Network - Dr. Leon Richard
  - Saint John, New Brunswick, Canada, E2L4L4
    - Horizon Health Network - Saint John Regional Hospital
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H2Y9
    - Queen Elizabeth II Health Sciences Centre
- Ontario
  - Hamilton, Ontario, Canada, L8V5C2
    - Juravinski Cancer Centre
  - Kingston, Ontario, Canada, K7L5P9
    - Kingston General Hospital, Cancer Centre of Southeastern Ontario/Oncology
  - Kitchener, Ontario, Canada, N2G1G3
    - Grand River Regional Cancer Center
  - St. Catharines, Ontario, Canada, L2S0A9
    - Niagara Health System
  - Toronto, Ontario, Canada, M4N3M
    - Sunnybrook
  - Toronto, Ontario, Canada, M5G1X5
    - University Health Network Princess Margaret Cancer Centre
- Quebec
  - Montréal, Quebec, Canada, H2L4M1
    - The Jewish General Hospital
  - Montréal, Quebec, Canada, H2W1T8
    - CHUM Hôtel Dieu
  - Québec, Quebec, Canada, G1S4L8
    - CHU de Québec - Hôpital du St Sacrement
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T7TI
    - Allan Blair Cancer Centre
  - Saskatoon, Saskatchewan, Canada, S7N4H4
    - Saskatoon Cancer Center, University of Saskatchewan
Germany
- - Aachen, Germany, 52074
    - University Hospital Aachen
  - Berlin, Germany, 13125
    - Helios Klinikum Berlin-Buch
  - Berlin, Germany, 10367
    - Praxisklinik Krebsheilkunde fur Frauen
  - Berlin, Germany, 14169
    - Studienzentrum City
  - Bottrop, Germany, 46236
    - Marienhospital Bottrop, Klinik für Gynäkologie und Geburtshilfe
  - Braunschweig, Germany, 38100
    - Studien GbR Braunschweig, Lorenz&HeckerWesche
  - Ebersberg, Germany, 85560
    - Praxis und Tagesklinik für gynäkologische Onkologie,
  - Eggenfelden, Germany, 84307
    - MVZ Eggenfelden
  - Erlangen, Germany, 91054
    - Frauenklinik/University Hospital Erlangen
  - Frankfurt, Germany, 60431
    - Agaplesion Markus Krankenhaus
  - Frankfurt, Germany, 60389
    - Centrum fur Hamatologie und Onkologie Bethanien
  - Frankfurt, Germany, 65929
    - Klinikum Frankfurt Höchst
  - Fürth, Germany, 90766
    - Onkol. GP Dres. med. Wilke/Wagner/Petzoldt
  - Halle (Saale), Germany, '06120
    - Universitätsfrauenklinik Halle (Saale)
  - Hamburg, Germany, 22457
    - Albertinen Krankenhaus
  - Hamburg, Germany, 20246
    - University Medical Center Hamburg-Eppendorf, Department of Gynecology
  - Karlsruhe, Germany, 76133
    - Städtisches Klinikum Karlsruhe
  - Kassel, Germany, 34125
    - Elisabeth Krankenhaus Kassel Brustzentrum
  - Leipzig, Germany, 04277
    - St. Elisabeth Krankenhaus Leipzig
  - Limburg, Germany, 65549
    - St. Vincenz KH Limburg Frauenklinik
  - Lübeck, Germany, 23538
    - UKSH Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe
  - Mainz, Germany, 55131
    - Universitätsmedizin Mainz
  - München, Germany, 81925
    - Praxis Gynäkologie Arabella
  - Oldenburg, Germany, 26133
    - University Clinic Oldenburg
  - Recklinghausen, Germany, 45657
    - Oncologianova GmbH
  - Rottweil, Germany, 78628
    - HELIOS Klinik Rottweil - Gynäkologie
  - Wiesbaden, Germany, 65189
    - St. Josefs-Hospital
Hungary
- - Budapest, Hungary, 1122
    - Országos Onkológiai Intézet - "B" Belgyógyászati Onkológiai és Klinikai Farmakológiai Osztály
  - Budapest, Hungary, 1145
    - Uzsoki Utcai Kórház - Onkoradiológia, Sugárterápia, Fővárosi Onkoradiológiai Központ
  - Debrecen, Hungary, 4032
    - University of Debrecen Medical Center, Clinic of Oncology
  - Győr, Hungary, 9023
    - Petz Aladár Megyei Oktatókórház - Onkoradiológiai Osztály
  - Szeged, Hungary, 6720
    - Szegedi Tudomanyegyetem Általános Orvostudományi Kar Szent-Györgyi Albert Klinikai Központ, Onkoterápiás Klinika
Ireland
- - Cork, Ireland
    - Bon Secours Hospital, Cork
  - Cork, Ireland
    - Cork University Hospital, Oncology Clinical Trials Unit
  - Dublin, Ireland
    - Mater Misericordiae University Hospital
  - Dublin, Ireland
    - Beaumont Hospital - Cancer Clinical Trials Unit
  - Dublin, Ireland
    - St James's Hospital, Cancer Clinical Trials Office, Old Admin Building,
  - Dublin, Ireland
    - St Vincent Hospital - Medical Oncology Research Department
  - Limerick, Ireland
    - University Hospital Limerick, Midwestern Cancer Centre
  - Sligo, Ireland
    - Sligo University Hospital
  - Waterford, Ireland
    - University Hospital Waterford, Cancer Research Department
Israel
- - Tel-Aviv, Israel, 64239
    - Sourasky Medical Center
- Central
  - Petah Tikva, Central, Israel, 49100
    - Rabin Medical Center (RMC)
- Tel Aviv
  - Ramat Gan, Tel Aviv, Israel, 52621
    - Sheba Medical Center Tel Hashomer
Italy
- - Ferrara, Italy, 44124
    - Azienda Ospedaliero-Universitaria di Ferrara
  - Florence, Italy, 50134
    - Azienda Ospedaliero-Universitaria Careggi/Florence University/Radiation Oncology Unit
  - Genoa, Italy, 16132
    - Department of Internal Medicine (DIMI) - IRCCS San Martino University Hospital
  - Grosseto, Italy, 58100
    - P.O. Misericordia AUSL Toscana Sud Est
  - Legnago, Italy, 37045
    - Ospedale "Mater Salutis" di Legnago, Dept. of Medical Oncology
  - Meldola, Italy, 47014
    - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) IRCCS
  - Milano, Italy, 20132
    - Ospedale San Raffaele
  - Milano, Italy, 20141
    - Istituto Europeo di Oncologia
  - Monza, Italy, 20900
    - Policlinico di Monza - Istituto di Oncologia del Policlinico di Monza
  - Parma, Italy, 43100
    - Medical Oncology Unit; University Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)
  - Prato, Italy, 59100
    - Nuovo Ospedale di Prato (NOP) - Azienda USL4 Prato
  - Treviglio, Italy, 24047
    - ASST Bergamo Ovest
  - Turin, Italy, 10126
    - S. Anna Hospital (Ospedale Sant'Anna)- Turin
Japan
- - Chiba, Japan, 260-8717
    - Chiba Cancer Center
  - Kyoto, Japan, 606-8507
    - Kyoto University Hospital/Breast Surgery
  - Osaka, Japan, 540-0006
    - National Hospital Organization Osaka National Hospital
  - Osaka, Japan, 541-8567
    - Osaka International Cancer Institute
- Aichi
  - Nagoya, Aichi, Japan, 467-8601
    - Nagoya City University Hospital/Dept. of Breast & Endocrine Surgery
- Hokkaido
  - Sapporo, Hokkaido, Japan, 003-0804
    - Department of Breast Surgery National Hospital Organization Hokkaido Cancer Center
Korea, Republic of
- - Seoul, Korea, Republic of, 03080
    - Seoul National University Hospital, Hematology-Medical Oncology
  - Seoul, Korea, Republic of, 03722
    - Severance Hospital Medical Doctor at Department of Medical Oncology
  - Seoul, Korea, Republic of, 06351
    - Samsung Medical Centre, Breast Cancer Center, Department of Medicine, Division of Hematology/Oncology
Mexico
- - Mexico City, Mexico, 14080
    - National Cancer Institute Mexico, Breast Cancer Department
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 66278
    - Centro Medico Zambrano Hellion
- Toluca
  - Toluca de Lerdo, Toluca, Mexico, 50180
    - Centro Oncologico Estatal ISSEMYM
Netherlands
- - Den Haag, Netherlands, 2545 AA
    - HagaZiekenhuis
  - Eindhoven, Netherlands, 5631 BM
    - Maxima Medisch Centrum
  - Geleen, Netherlands, 6162 BG
    - Zuyderland Ziekenhuis, Oncology
  - Nieuwegein, Netherlands, 3435 CM
    - St Antonius hospital
  - Zaandam, Netherlands, 1502 DV
    - Zaans Medical Center
  - Zwolle, Netherlands, 8025 AB
    - Isala, Dept of Medical Oncology
Poland
- - Gdansk, Poland, 80-952
    - Uniwersyteckie Centrum Kliniczne (UCK), Klinika Onkologii I Radioterapii
  - Opole, Poland, 45-001
    - Opolskie Centrum Onkologii, Oddzial Onkologii Klinicznej
  - Warsaw, Poland, 02-781
    - Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
  - Łódź, Poland
    - Instytut MSF Spółka z ograniczoną odpowiedzialnością
Portugal
- - Lisboa, Portugal, 1500-650
    - Hospital da Luz
  - Lisboa, Portugal, 1099-023
    - Instituto Português de Oncologia (IPO) de Lisboa Francisco Gentil
  - Lisboa, Portugal, 1998-018
    - CUF Descobertas Hospital, Hemato-Oncologia
  - Lisbon, Portugal, 1400-038
    - Centro Clinico Champalimaud
  - Porto, Portugal, 4200
    - Instituto Português de Oncologia (IPO) Francisco Gentil do Porto
Spain
- - A Coruña, Spain, 15009
    - Centro Oncológico de Galicia
  - A Coruña, Spain, 15006
    - Complejo Hospitalario Universitario A Coruña (CHUAC)
  - Alicante, Spain, 03010
    - Hospital General Universitario Alicante
  - Badalona, Spain, 08916
    - Ico Badalona
  - Barcelona, Spain, 08003
    - Hospital Del Mar
  - Barcelona, Spain, 08036
    - Hospital Clínic Barcelona
  - Barcelona, Spain, 08028
    - Hospital Universitari Quiron Dexeus
  - Barcelona, Spain, 08402
    - Hospital General de Granollers
  - Barcelona, Spain, 08908
    - Instituto Catalán de Oncología (ICO) de L'Hospitalet de Llobregat
  - Barcelona, Spain, 8035
    - Hospital Vall d´hebron
  - Burgos, Spain, 09006
    - Hospital Universitario de Burgos
  - Castellón De La Plana, Spain, 12002
    - Consorcio Hospitalario Provincial de Castellón
  - Cáceres, Spain, 10003
    - San Pedro de Alcántara
  - Córdoba, Spain, 14004
    - Hospital Reina Sofia
  - Elche, Spain, 03203
    - Hospital General Universitario de Elche
  - Girona, Spain, 17007
    - ICO/ H. Josep Trueta
  - León, Spain, 24001
    - Complejo Asistencial Universitario de Leon
  - Madrid, Spain, 28040
    - Fundacion Jimenez Diaz
  - Madrid, Spain, 28034
    - Hospital Universitario Ramon y Cajal
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain, 28007
    - Hospital Universitario Gregorio Marañon
  - Madrid, Spain, 28033
    - MD Anderson Cancer Center
  - Madrid, Spain, 28922
    - Hospital Universitario Fundacion Alcorcon
  - Madrid, Spain, 28046
    - Hospital La Paz, Servicio de Oncologia Médica
  - Madrid, Spain, 28050
    - CIOCC - Centro Integral Oncológico Clara Campal / Hospital HM Universitario Sanchinarro
  - Madrid, Spain, 28222
    - Hospital Puerta de Hierro Majadahonda, Oncologia Médica
  - Murcia, Spain, 30120
    - Hospital Clinico Universitario Virgen de La Arrixaca
  - Murcia, Spain, 30008
    - Hospital General Universitario José Mª Morales Meseguer
  - Málaga, Spain, 29010
    - Hospital Clinico Universitario Virgen de la Victoria
  - Oviedo, Spain, 33011
    - Hospital Universitario Central de Asturias
  - Palma, Spain, 07198
    - Hospital Son Llatzer
  - Palma, Spain, 07120
    - Hospitali Universitari son Espases
  - Pamplona, Spain, 31008
    - Complejo Hospitalario de Navarra
  - Reus, Spain, 43204
    - Hospital Universitari Sant Joan de Reus
  - San Sebastián, Spain, 20014
    - Hospital Universitario Donostia
  - Sant Joan Despì, Spain, 08970
    - Hospital de Sant Juan Despi Moisés Broggi
  - Santiago, Spain, 15706
    - Hospital Clinico Universitario de Santiago
  - Sevilla, Spain, 41013
    - Hospital Universitario Virgen del Rocio
  - Sevilla, Spain, 41013
    - Hospital Quiron Sagrado Corazon
  - Sevilla, Spain, 41009
    - Hospital Unversitario Virgen Macarena
  - Terrassa, Spain, 08227
    - Consorci Sanitari de Terrassa
  - Toledo, Spain, 45004
    - Hospital Virgen De La Salud
  - Valencia, Spain, 46010
    - Hospital Clinico Universitario de Valencia
  - Valencia, Spain, 46015
    - Hosital Arnau de Vilanova Valencia
  - Zaragoza, Spain, 50009
    - Hospital Clinico Universitario Lozano Blesa
  - Zaragoza, Spain, 50009
    - Hospital Universitario Miguel Servet
Sweden
- - Gävle, Sweden, 801 87
    - Gävle Hospital, Dept. of Oncology
  - Göteborg, Sweden, 413 45
    - Sahlgrenska University Hospital, Dept. Oncology
  - Stockholm, Sweden, 171 76
    - Karolinska Universitetssjukhuset, Bröstcentrum A2:00
  - Uppsala, Sweden, 751 85
    - Akademiska Sjukhuset Uppsala (University Hospital), Onkologkliniken
  - Örebro, Sweden, 701 85
    - Universitetssjukhuset Örebro (University Hospital) Örebro, Onkologkliniken
Switzerland
- - Basel, Switzerland, 4031
    - Dep. Oncology, University Hospital
  - Fribourg, Switzerland, 1708
    - HFR Fribourg, Oncology Department
  - Luzern, Switzerland, 6000
    - Luzerner Kantonsspital, Dept. of Medical Oncology
  - Luzern, Switzerland, 6006
    - Onkologisches Forschungszentrum Klinik St. Anna, Hirslanden
  - St.Gallen, Switzerland, 9007
    - Kantonsspital St.Gallen, Onkologie/Hämatologie
  - Zurich, Switzerland, 8008
    - Brust-Zentrum Zurich
  - Zurich, Switzerland, 8091
    - Universitätsspital Zürich, Klinik für Onkologie
- Aargau
  - Baden, Aargau, Switzerland, 5404
    - Kantonspital Baden
- Bern
  - Thun, Bern, Switzerland, 3600
    - Spital STS AG, Onkologiezentrum Thun-Berner Oberland
- Geneva
  - Genève, Geneva, Switzerland, 1211
    - Hopitaux Universitaires de Geneve
- Graubünden
  - Chur, Graubünden, Switzerland, 7000
    - Kantonsspital Graubünden
- Tessin
  - Bellinzona, Tessin, Switzerland, 6500
    - IOSI-Breast Cancer Unit-Ospedale San Giovanni-Bellinzona
  - Locarno, Tessin, Switzerland, 6600
    - Fondazione Oncologia Lago Maggiore, Locarno
Taiwan
- - Kaohsiung, Taiwan, 807
    - Kaohsiung Medical University Hospital
  - Tainan, Taiwan, 704
    - National Cheng Kung University Hospital, Division of Hemato-Oncology, Dept. Internal Medicine
  - Taipei, Taiwan, 100
    - National Taiwan University Hospital/Department of Surgery
  - Taipei, Taiwan, 112
    - Taipei Veterans General Hospital/General Surgery
- Changhua County
  - Changhua, Changhua County, Taiwan, 500
    - Changhua Christian Hospital/General Surgery
United Kingdom
- - Birmingham, United Kingdom, B18 7QH
    - City Hospital Birmingham
  - Bristol, United Kingdom, BS2 8ED
    - University Hospitals Bristol NHS Foundation Trust
  - Cardiff, United Kingdom, CF14 2TL
    - Velindre Cancer Centre
  - Chelsea, United Kingdom, SW3 6JJ
    - Royal Marsden Hospital Chelsea
  - Glasgow, United Kingdom, G12 0YN
    - The Beatson West of Scotland Cancer Centre
  - Leicester, United Kingdom, LE1 5WW
    - University Hospitals of Leicester
  - Liverpool, United Kingdom, L7 8XP
    - Royal Liverpool University Hospital
  - London, United Kingdom, SE1 7EH
    - Guy's and St Thomas' NHS Foundation Trust
  - London, United Kingdom, SW3 6JJ
    - The Royal Marsden Sutton
  - London, United Kingdom, W6 8RF UK
    - Charing Cross Hospital
  - Maidstone, United Kingdom, ME16 9QQ
    - Maidstone Hospital, Kent Oncology Centre
  - Manchester, United Kingdom, M20 4BX
    - The Christie Nhs Foundation Trust
  - Newcastle upon Tyne, United Kingdom, NE7 7DN
    - Northern Centre for Cancer Care
  - Nottingham, United Kingdom, NG5 1PB
    - Nottingham University Hospitals NHS TRUST UK
  - Sheffield, United Kingdom, S10 2SJ
    - Weston Park Hospital, Sheffield Teaching Hospitals
  - Truro, United Kingdom, TR1 3LQ
    - Royal Cornwall Hospitals NHS Trust, Oncology Trials, Sunrise Centre
United States
- Alabama
  - Mobile, Alabama, United States, 36604
    - University of South Alabama Mitchell Cancer Institute
  - Mobile, Alabama, United States, 36608
    - Southern Cancer Center PC - Providence
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Cancer Center
- Arizona
  - Phoenix, Arizona, United States, 85054
    - Mayo Clinic in Arizona
- California
  - Anaheim, California, United States, 92806
    - Kaiser Permanente Anaheim Medical Center
  - Baldwin Park, California, United States, 91706
    - Kaiser Permanente Baldwin Park Medical Center
  - Bellflower, California, United States, 90706
    - Kaiser Permanente Bellflower Medical Center
  - Fontana, California, United States, 92335
    - Kaiser Permanente Fontana Medical Center
  - Greenbrae, California, United States, 94904
    - Marin Cancer Care
  - Greenbrae, California, United States, 94904
    - Marin Cancer Center
  - Harbor City, California, United States, 90710
    - Kaiser Permanente Harbor City Medical Center
  - Irvine, California, United States, 92618
    - Kaiser Permanente Irvine Medical Center
  - La Jolla, California, United States, 92093
    - UCSD Moores Cancer Center
  - Long Beach, California, United States, 90806
    - Long Beach Memorial Medical Center - Todd Cancer Institute
  - Los Angeles, California, United States, 90048
    - Cedars Sinai Medical Center
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Sunset Medical Center
  - Oakland, California, United States, 94611
    - Kaiser Permanente Oakland Medical Center
  - Palo Alto, California, United States, 94301
    - Palo Alto Medical Foundation Health Care
  - Panorama City, California, United States, 91402
    - Kaiser Permanente Panorama City Medical Center
  - Riverside, California, United States, 92505
    - Kaiser Permanente Riverside Medical Center
  - Roseville, California, United States, 95661
    - Kaiser Permanente Roseville Medical Center
  - Sacramento, California, United States, 95825
    - Kaiser Permanente Sacramento Medical Center
  - San Diego, California, United States, 92123
    - Sharp Memorial Hospital
  - San Diego, California, United States, 92093
    - University of California
  - San Diego, California, United States, 92120
    - Kaiser Permanente San Diego Medical Center
  - San Francisco, California, United States, 94115
    - UCSF Helen Diller Comprehensive Cancer Center
  - San Francisco, California, United States, 94115
    - Kaiser Permanente San Francisco Medical Center
  - San Jose, California, United States, 95119
    - Kaiser Permanente San Jose Medical Center
  - San Leandro, California, United States, 94577
    - Kaiser Permanente San Leandro Medical Center
  - San Marcos, California, United States, 92078
    - Kaiser Permanente San Marcos Medical Center
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Santa Clara Medical Center
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente South San Francisco Medical Center
  - Stanford, California, United States, 94305
    - Stanford Women's Cancer Center
  - Vallejo, California, United States, 94589
    - Kaiser Permanente Vallejo Medical Center
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente Walnut Creek Medical Center
  - West Los Angeles, California, United States, 90034
    - Kaiser Permanente Cadillac Medical Center
  - Woodland Hills, California, United States, 91367
    - Kaiser Permanente Woodland Hills Medical Center
- Colorado
  - Denver, Colorado, United States, 80222
    - Western States Cancer Research NCORP
- Connecticut
  - Hartford, Connecticut, United States, 06102
    - Hartford Hospital
  - New Britain, Connecticut, United States, 06053
    - Memorial Sloan Cancer Center - Hartford Healthcare Center Institute at HOCC
- Delaware
  - Newark, Delaware, United States, 19718
    - Christiana Health System - Christiana Hospital
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Georgetown University Medical Center
  - Washington, District of Columbia, United States, 20037
    - George Washington University Medical Faculty Associates
- Florida
  - Clearwater, Florida, United States, 33756
    - Morton Plant Hospital
  - Jacksonville, Florida, United States, 32224
    - Mayo Clinic in Florida
  - Miami, Florida, United States, 33136
    - University of Miami Miller School of Medicine Sylvester Cancer Center
  - Miami Beach, Florida, United States, 33140
    - Mount Sinai Comprehensive Cancer Center
  - Orlando, Florida, United States, 32806
    - Orlando Health Cancer Institute
  - Orlando, Florida, United States, 32804
    - Advent Health Orlando
- Georgia
  - Albany, Georgia, United States, 31701
    - Phoebe Putney Memorial Hospital
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital
  - Savannah, Georgia, United States, 317404
    - Memorial Health University Medical Center
- Illinois
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
  - Chicago, Illinois, United States, 60612
    - University of Illinois
  - Chicago, Illinois, United States, 60637
    - University of Chicago Cancer Center LAPS
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Cancer Care Specialist of Central Illinois
  - Evanston, Illinois, United States, 60201
    - NorthShore University Health System - Evanston Hospital
  - Harvey, Illinois, United States, 60426
    - Ingalls Memorial Hospital
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology Hematology Associates Limited
  - Park Ridge, Illinois, United States, 60068
    - Advocate Lutheran General Hospital
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Rockford, Illinois, United States, 61108
    - OSF Saint Anthony Medical Center
  - Skokie, Illinois, United States, 60017
    - Orchard Healthcare Research Inc.
  - Skokie, Illinois, United States, 60077
    - NorthShore Hematology Oncology-Libertyville
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana University - Melvin and Bren Simon Cancer Center LAPS
  - Muncie, Indiana, United States, 47303
    - IU Health Ball Memorial Hospital
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic PC-William R Bliss Cancer Center
  - Ames, Iowa, United States, 50010
    - McFarland Clinic, P.C.
  - Cedar Rapids, Iowa, United States, 52403
    - Physicians' Clinic of Iowa PC
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates - Des Moines
  - Des Moines, Iowa, United States, 50309
    - Iowa Oncology Research Assoc
  - Waterloo, Iowa, United States, 50702
    - Covenant Medical Center
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky-Markey Cancer Center
  - Louisville, Kentucky, United States, 20202
    - Norton Cancer Institute - Brownsboro
- Louisiana
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center
- Maine
  - Bangor, Maine, United States, 04401
    - Eastern Maine Medical Center d/b/a Northern Light Cancer Institute
  - Scarborough, Maine, United States, 04074
    - New England Cancer Specialists - Scarborough
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Anne Arundel Medical Center
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center
  - Baltimore, Maryland, United States, 21202
    - Mercy Medical Center
  - Baltimore, Maryland, United States, 21218
    - MedStar Good Samaritan Hospital
  - Baltimore, Maryland, United States, 21237
    - MedStar Franklin Square Medical Center Winberg Cancer Institute
  - Baltimore, Maryland, United States, 21237
    - MedStar Union Memorial Hospital
  - Baltimore, Maryland, United States, 21287
    - JHU Sidney Kimmel Comprehensive Cancer Center LAPS
  - Baltimore, Maryland, United States, 21701
    - Frederick Regional Health System James M Stockman Cancer Institute
  - Bethesda, Maryland, United States, 20817
    - Maryland Oncology Hematology PA
  - Salisbury, Maryland, United States, 21801
    - Tidal Health Peninsula Regional
  - Silver Spring, Maryland, United States, 20910
    - Holy Cross Hospital
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center
  - Boston, Massachusetts, United States, 02115
    - Dana Farber Cancer Institute
  - Lowell, Massachusetts, United States, 01852
    - Lowell General Hospital
  - Plymouth, Massachusetts, United States, 02360
    - Beth Israel Deaconess Hospital - Plymouth Jordan Club Cancer Center
- Michigan
  - Ann Arbor, Michigan, United States, 48106
    - Saint Joseph Mercy Hospital
  - Grand Rapids, Michigan, United States, 49503
    - Cancer Research Consortium of West Michigan NCORP
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health Butterworth Research Pharmacy
  - Livonia, Michigan, United States, 48152
    - Trinity Health Michigan
- Minnesota
  - Duluth, Minnesota, United States, 55805
    - Essentia Health NCORP
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic
  - Rochester, Minnesota, United States, 55902
    - Mayo Clinic-Rochester
  - Saint Cloud, Minnesota, United States, 56303
    - Coborn Cancer Center at Saint Cloud Hospital
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro Minnesota Community Oncology Research Consortium
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro Minnesota Oncology Research Consortium
- Missouri
  - Kansas City, Missouri, United States, 64111
    - St. Luke's Hospital
  - Rolla, Missouri, United States, 65401
    - Phelps Country Regional Medical Center
  - Saint Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - Saint Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - Springfield, Missouri, United States, 65807
    - Cancer Research for the Ozarks NCORP
- Nebraska
  - Lincoln, Nebraska, United States, 68506
    - Nebraska Hematology and Oncology
  - Lincoln, Nebraska, United States, 68510
    - Southeast Nebraska Cancer Center
  - Omaha, Nebraska, United States, 68106
    - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, United States, 68106
    - Cancer Alliance of Nebraska
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - New Hampshire Oncology-Hematology PA, Concord
  - Hooksett, New Hampshire, United States, 03106
    - New Hampshire Oncology-Hematology PA
  - Hooksett, New Hampshire, United States, 03106
    - Solinsky Center for Cancer Care
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Medical Center
  - Lebanon, New Hampshire, United States, 03766
    - Norris Cotton Cancer Center - Nashua
- New Jersey
  - Englewood, New Jersey, United States, 07631
    - Englewood Hospital and Medical Center
  - Hackensack, New Jersey, United States, 07601
    - Hackensack University Medical Center
  - New Brunswick, New Jersey, United States, 08903
    - Rutgers Cancer Center Institute of New Jersey
  - Somerville, New Jersey, United States, 08876
    - Robert Wood Johnson University Hospital Somerset
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - University of New Mexico Comprehensive Cancer Center
- New York
  - Bronx, New York, United States, 10461
    - Montefiore Medical Center - Einstein Campus
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Institute
  - Cooperstown, New York, United States, 11326
    - Mary Imogene Bassett Hospital
  - East Syracuse, New York, United States, 13057
    - Hematology Oncology Associates of Central New York - East Syracuse
  - Jamaica, New York, United States, 11432
    - Queens Hospital Center
  - New Hyde Park, New York, United States, 11042
    - Northwell Health NCORP
  - New York, New York, United States, 10016
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone
  - New York, New York, United States, 10011
    - Beth Israel Medical Center - New York
  - New York, New York, United States, 10065
    - Memorial Sloan Kettering Cancer Center - LAPS
  - Oneonta, New York, United States, 13820
    - Oneonta FoxCare Center
  - Syracuse, New York, United States, 13210
    - SUNY Upstate Medical University
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - The Charlotte-Mecklenburg Hospital Authority
  - Charlotte, North Carolina, United States, 28204
    - Carolinas Medical Center/Levine Cancer Institute
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Greensboro, North Carolina, United States, 27403
    - Cone Health Cancer Center
  - Kinston, North Carolina, United States, 28504
    - Kinston Medical Specialists, PA
  - Pinehurst, North Carolina, United States, 28374
    - First Health of the Carolinas - Moore Regional Hospital
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic
  - Cleveland, Ohio, United States, 44111
    - Cleveland Clinic Cancer Center/Fairview Hospital
  - Columbus, Ohio, United States, 43210
    - Ohio State University Comprehensive Cancer Center
  - Mayfield Heights, Ohio, United States, 44124
    - Cleveland Clinic Cancer Center/Hillcrest Hospital
- Oklahoma
  - Lawton, Oklahoma, United States, 73505
    - Cancer Centers of Southwest Oklahoma Research
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, United States, 73104
    - Stephenson Cancer Center
- Oregon
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
- Pennsylvania
  - Dunmore, Pennsylvania, United States, 18512
    - Hematology & Oncology Associates of Northeastern PA
  - Hershey, Pennsylvania, United States, 17033
    - Penn State Milton S Hershey Medical Center
  - Lancaster, Pennsylvania, United States, 17604
    - Lancaster General Hospital
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19104
    - University of Pennsylvania/Abramson Cancer Center
  - Philadelphia, Pennsylvania, United States, 19107
    - Thomas Jefferson University
  - Philadelphia, Pennsylvania, United States, 19106
    - Pennsylvania Hospital
  - Philadelphia, Pennsylvania, United States, 19104
    - Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine
  - Pittsburgh, Pennsylvania, United States, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC Magee Women's Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - University of Pittsburgh Cancer Institute- Hillman Cancer Center
  - Wyomissing, Pennsylvania, United States, 19610
    - Reading Hospital/McGlinn Cancer Institute
  - York, Pennsylvania, United States, 17403
    - WellSpan Health York Cancer Center
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Rhode Island Hospital
  - Providence, Rhode Island, United States, 02905
    - Women & Infants Hospital of Rhode Island
- South Carolina
  - Columbia, South Carolina, United States, 29169
    - Lexington Medical Center/Lexington Oncology Associates
- South Dakota
  - Aberdeen, South Dakota, United States, 57401
    - Avera Cancer Institute-Aberdeen
  - Rapid City, South Dakota, United States, 57701
    - Monument Health Rapid City Hospital
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital/Regional Cancer Care Institute
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
- Tennessee
  - Nashville, Tennessee, United States, 37208
    - Nashville General Hospital at Meharry
  - Nashville, Tennessee, United States, 37204
    - Vanderbilt University/Ingram Cancer Center
- Texas
  - Houston, Texas, United States, 77030
    - MD Anderson Cancer Center
  - Houston, Texas, United States, 77030
    - Houston Methodist Hospital Cancer Center
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
  - Laredo, Texas, United States, 78045
    - Doctors Hospital of Laredo
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute - University of Utah
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Inova Schar Cancer Institute
  - Richmond, Virginia, United States, 23298
    - VCU Massey Cancer Center
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - CAMC Cancer Center
- Wisconsin
  - Appleton, Wisconsin, United States, 54913
    - ThedaCare Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54301
    - HSHS Saint Vincent Hospital
  - La Crosse, Wisconsin, United States, 54601
    - Gunderson Lutheran Medical Center
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Hospital and Clinics
  - Milwaukee, Wisconsin, United States, 53210
    - Wheaton Franciscan Healthcare - St. Joseph
  - Milwaukee, Wisconsin, United States, 53711
    - Columbia St. Mary's Water Tower Medical Commons
  - Racine, Wisconsin, United States, 53405
    - Wheaton Franciscan Healthcare-All Saints
  - Waukesha, Wisconsin, United States, 53188
    - UW Cancer Center at ProHealth Care
  - Waukesha, Wisconsin, United States, 53188
    - Orchard Healthcare Research Inc.
  - Wauwatosa, Wisconsin, United States, 53226
    - Wheaton Franciscan Healthcare - Wauwatosa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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.

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:

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.
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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Palbociclib Drug: Standard Adjuvant Endocrine Therapy
Other: Arm B Standard adjuvant endocrine therapy for a duration of at least 5 years.	Drug: Standard Adjuvant Endocrine Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive Disease Free Survival (iDFS) Time Frame: 4 years	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.	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive Disease Free Survival (iDFS) Excluding Second Primary Invasive Cancers of Non-breast Origin. Time Frame: 4 years	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.	4 years
Distant Recurrence-free Survival (DRFS) Time Frame: 4 years	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.	4 years
Overall Survival (OS) Time Frame: 4 years	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.	4 years
Locoregional Recurrences-free Survival (LRRFS) Time Frame: 4 years	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.	4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance Foundation Trials, LLC.

Collaborators

Pfizer

Breast International Group

NSABP Foundation Inc

Austrian Breast & Colorectal Cancer Study Group

PrECOG, LLC.

Investigators

Principal Investigator: Erica Mayer, MD, Dana-Farber Cancer Institute
Principal Investigator: Angela DeMichele, MD, University of Pennsylvania
Principal Investigator: Michael Gnant, MD, ABCSG, Medical University Vienna
Principal Investigator: Evanthia Galanis, MD, Alliance Foundation Trials, LLC.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

November 1, 2020

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

July 30, 2015

First Posted (Estimated)

July 31, 2015

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

AFT-05
ABCSG 42 (Other Identifier: ABCSG GmbH)
BIG 14-03 (Other Identifier: Breast International Group)
2014-005181-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Pfizer

Completed

A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product

Healthy

United States
Pfizer

Completed

A Pilot Study To Investigate The Effect Of Concurrent Antacid Administration On The Bioavailability Of Six Experimental Formulations Of Palbociclib

Healthy

United States

PALbociclib CoLlaborative Adjuvant Study (PALLAS)

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Breast Cancer

Clinical Trials on Palbociclib

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations