PALbociclib CoLlaborative Adjuvant Study

Breast Cancer Clinical Trial

— PALLAS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02513394
• Other study ID #: AFT-05
• Secondary ID: ABCSG 42BIG 14-0
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 2015
• Est. completion date: September 2025

Study information

• Verified date: April 2023
• Source: Alliance Foundation Trials, LLC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5796
• Est. completion date: September 2025
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Palbociclib

• Standard Adjuvant Endocrine Therapy

Locations

Country	Name	City	State
Australia	Flinders Drive	Bedford Park	South Australia
Australia	Southern Highlands Cancer Centre	Bowral	New South Wales
Australia	Royal Brisbane & Women's Hospital	Brisbane	Queensland
Australia	St John of God Bunbury Hospital	Bunbury	Western Australia
Australia	Coffs Harbour Health Campus - MNCCI	Coffs Harbour	New South Wales
Australia	The Northern Hospital	Epping	Victoria
Australia	St Vincent's Hospital	Fitzroy	Victoria
Australia	Peninsula Health - Frankston Hospital	Frankston	Victoria
Australia	The Breast & Endocrine Centre	Gateshead	New South Wales
Australia	University Hospital, Geelong	Geelong	Victoria
Australia	Gosford Hospital	Gosford	New South Wales
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Macquarie University Hospital	Macquarie Park	New South Wales
Australia	Peninsula Health - Frankston Hospital	Melbourne	Victoria
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Breast Cancer Research Centre - WA	Nedlands	Western Australia
Australia	Orange Health Service	Orange	New South Wales
Australia	Western Health, Sunshine Hospital	St. Albans	Victoria
Australia	South West Healthcare, Warrnambool	Warrnambool	Victoria
Australia	Wollongong Hospital	Wollongong	New South Wales
Austria	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	St. Pölten
Austria	Breast Centre Dr. Wette Viktor	St. Veit an der Glan
Austria	Phyrn-Eisenwurzen Klinikum Steyr	Steyr
Austria	Hospital Hietzing, Gynecology	Vienna
Austria	Klinik Ottakring	Vienna
Austria	Medical University of Vienna Department of Obstetrics and Gynaecology	Vienna
Austria	Medical University Vienna - Coop Group Surgery/Oncology	Vienna
Austria	St. Josef Krankenhaus, Department of Internal I	Vienna
Austria	Salzkammergut-Klinikum Vöcklabruck	Voecklabruck
Austria	Brustordination Dr. Thiel	Weiz
Austria	Klinikum Wels - Grieskirchen GmbH, Department of Internal Medicine IV	Wels
Austria	LKH Wolfsberg, Department of Surgery	Wolfsberg
Austria	Landesklinikum Wr. Neustadt, Department of Surgery	Wr. Neustadt
Belgium	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	Bruxelles
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
Canada	BC Cancer Agency- Abbotsford Centre	Abbotsford	British Columbia
Canada	Tom Baker Cancer Centre - Dept. of Oncology	Calgary	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	BC Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior	Kelowna	British Columbia
Canada	Kingston General Hospital, Cancer Centre of Southeastern Ontario/Oncology	Kingston	Ontario
Canada	Grand River Regional Cancer Center	Kitchener	Ontario
Canada	The Vitalite Health Network - Dr. Leon Richard	Moncton	New Brunswick
Canada	CHUM Hôtel Dieu	Montréal	Quebec
Canada	The Jewish General Hospital	Montréal	Quebec
Canada	CHU de Québec - Hôpital du St Sacrement	Québec	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Horizon Health Network - Saint John Regional Hospital	Saint John	New Brunswick
Canada	Saskatoon Cancer Center, University of Saskatchewan	Saskatoon	Saskatchewan
Canada	Niagara Health System	St. Catharines	Ontario
Canada	Sunnybrook	Toronto	Ontario
Canada	University Health Network Princess Margaret Cancer Centre	Toronto	Ontario
Canada	BC Cancer Agency - Vancouver Cancer Centre	Vancouver	British Columbia
Canada	CancerCare Manitoba - St. Boniface Hospital	Winnipeg	Manitoba
Germany	University Hospital Aachen	Aachen
Germany	Helios Klinikum Berlin-Buch	Berlin
Germany	Praxisklinik Krebsheilkunde für Frauen	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	Agaplesion Markus Krankenhaus	Frankfurt
Germany	Centrum für Hämatologie und Onkologie Bethanien	Frankfurt
Germany	Klinikum Frankfurt Höchst	Frankfurt
Germany	Onkol. GP Dres. med. Wilke/Wagner/Petzoldt	Fürth
Germany	Universitätsfrauenklinik Halle (Saale)	Halle (Saale)
Germany	Albertinen Krankenhaus	Hamburg
Germany	University Medical Center Hamburg-Eppendorf, Department of Gynecology	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
Hungary	Országos Onkológiai Intézet - "B" Belgyógyászati Onkológiai és Klinikai Farmakológiai Osztály	Budapest
Hungary	Uzsoki Utcai Kórház - Onkoradiológia, Sugárterápia, Fovárosi Onkoradiológiai Központ	Budapest
Hungary	University of Debrecen Medical Center, Clinic of Oncology	Debrecen
Hungary	Petz Aladár Megyei Oktatókórház - Onkoradiológiai Osztály	Gyor
Hungary	Szegedi Tudomanyegyetem Általános Orvostudományi Kar Szent-Györgyi Albert Klinikai Központ, Onkoterápiás Klinika	Szeged
Ireland	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
Israel	Rabin Medical Center (RMC)	Petah Tikva	Central
Israel	Sheba Medical Center Tel Hashomer	Ramat Gan	Tel Aviv
Israel	Sourasky Medical Center	Tel-Aviv
Italy	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	Istituto Europeo di Oncologia	Milano
Italy	Ospedale San Raffaele	Milano
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
Japan	Chiba Cancer Center	Chiba
Japan	Kyoto University Hospital/Breast Surgery	Kyoto
Japan	Nagoya City University Hospital/Dept. of Breast & Endocrine Surgery	Nagoya	Aichi
Japan	National Hospital Organization Osaka National Hospital	Osaka
Japan	Osaka International Cancer Institute	Osaka
Japan	Department of Breast Surgery National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido
Korea, Republic of	Samsung Medical Centre, Breast Cancer Center, Department of Medicine, Division of Hematology/Oncology	Seoul
Korea, Republic of	Seoul National University Hospital, Hematology-Medical Oncology	Seoul
Korea, Republic of	Severance Hospital Medical Doctor at Department of Medical Oncology	Seoul
Mexico	National Cancer Institute Mexico, Breast Cancer Department	Mexico City
Mexico	Centro Médico Zambrano Hellion	Monterrey	Nuevo León
Mexico	Centro Oncológico Estatal ISSEMYM	Toluca de Lerdo	Toluca
Netherlands	Hagaziekenhuis	Den Haag
Netherlands	Máxima Medisch Centrum	Eindhoven
Netherlands	Zuyderland Ziekenhuis, Oncology	Geleen
Netherlands	St Antonius Hospital	Nieuwegein
Netherlands	Zaans Medical Center	Zaandam
Netherlands	Isala, Dept of Medical Oncology	Zwolle
Poland	Uniwersyteckie Centrum Kliniczne (UCK), Klinika Onkologii I Radioterapii	Gdansk
Poland	Instytut MSF Spólka z ograniczona odpowiedzialnoscia	Lódz
Poland	Opolskie Centrum Onkologii, Oddzial Onkologii Klinicznej	Opole
Poland	Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie	Warsaw
Portugal	CUF Descobertas Hospital, Hemato-Oncologia	Lisboa
Portugal	Hospital da Luz	Lisboa
Portugal	Instituto Português de Oncologia (IPO) de Lisboa Francisco Gentil	Lisboa
Portugal	Centro Clinico Champalimaud	Lisbon
Portugal	Instituto Português de Oncologia (IPO) Francisco Gentil do Porto	Porto
Spain	Centro Oncologico de Galicia	A Coruña
Spain	Complejo Hospitalario Universitario A Coruña (CHUAC)	A Coruña
Spain	Hospital General Universitario Alicante	Alicante
Spain	ICO Badalona	Badalona
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital General de Granollers	Barcelona
Spain	Hospital Universitari Quirón Dexeus	Barcelona
Spain	Hospital Vall d´Hebron	Barcelona
Spain	Instituto Catalán de Oncología (ICO) de L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	San Pedro de Alcántara	Cáceres
Spain	Consorcio Hospitalario Provincial de Castellon	Castellón De La Plana
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	CIOCC - Centro Integral Oncológico Clara Campal / Hospital HM Universitario Sanchinarro	Madrid
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital La Paz, Servicio de Oncologia Médica	Madrid
Spain	Hospital Puerta de Hierro Majadahonda, Oncologia Médica	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Fundacion Alcorcón	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	MD Anderson Cancer Center	Madrid
Spain	Hospital Clínico Universitario Virgen de la Victoria	Málaga
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital General Universitario José Mª Morales Meseguer	Murcia
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Son Llatzer	Palma
Spain	Hospitali Universitari son Espases	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 Quirón Sagrado Corazón	Sevilla
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Unversitario Virgen Macarena	Sevilla
Spain	Consorci Sanitari de Terrassa	Terrassa
Spain	Hospital Virgen de la Salud	Toledo
Spain	Hosital Arnau de Vilanova Valencia	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Universitario Miguel Servet	Zaragoza
Sweden	Gävle Hospital, Dept. of Oncology	Gävle
Sweden	Sahlgrenska University Hospital, Dept. Oncology	Göteborg
Sweden	Universitetssjukhuset Örebro (University Hospital) Örebro, Onkologkliniken	Örebro
Sweden	Karolinska Universitetssjukhuset, Bröstcentrum A2:00	Stockholm
Sweden	Akademiska Sjukhuset Uppsala (University Hospital), Onkologkliniken	Uppsala
Switzerland	Kantonspital Baden	Baden	Aargau
Switzerland	Dep. Oncology, University Hospital	Basel
Switzerland	IOSI-Breast Cancer Unit-Ospedale San Giovanni-Bellinzona	Bellinzona	Tessin
Switzerland	Kantonsspital Graubünden	Chur	Graubünden
Switzerland	HFR Fribourg, Oncology Department	Fribourg
Switzerland	Hôpitaux Universitaires de Genève	Genève	Geneva
Switzerland	Fondazione Oncologia Lago Maggiore, Locarno	Locarno	Tessin
Switzerland	Luzerner Kantonsspital, Dept. of Medical Oncology	Luzern
Switzerland	Onkologisches Forschungszentrum Klinik St. Anna, Hirslanden	Luzern
Switzerland	Kantonsspital St.Gallen, Onkologie/Hämatologie	St.Gallen
Switzerland	Spital STS AG, Onkologiezentrum Thun-Berner Oberland	Thun	Bern
Switzerland	Brust-Zentrum Zürich	Zurich
Switzerland	Universitätsspital Zürich, Klinik für Onkologie	Zurich
Taiwan	Changhua Christian Hospital/General Surgery	Changhua	Changhua County
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	National Cheng Kung University Hospital, Division of Hemato-Oncology, Dept. Internal Medicine	Tainan
Taiwan	National Taiwan University Hospital/Department of Surgery	Taipei
Taiwan	Taipei Veterans General Hospital/General Surgery	Taipei
United Kingdom	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	Charing Cross Hospital	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	The Royal Marsden Sutton	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 States	Avera Cancer Institute-Aberdeen	Aberdeen	South Dakota
United States	Phoebe Putney Memorial Hospital	Albany	Georgia
United States	University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico
United States	McFarland Clinic PC-William R Bliss Cancer Center	Ames	Iowa
United States	McFarland Clinic, P.C.	Ames	Iowa
United States	Kaiser Permanente Anaheim Medical Center	Anaheim	California
United States	Katmai Oncology Group	Anchorage	Alaska
United States	Providence Alaska Cancer Center	Anchorage	Alaska
United States	Saint Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	ThedaCare Regional Cancer Center	Appleton	Wisconsin
United States	Emory University Hospital	Atlanta	Georgia
United States	Kaiser Permanente Baldwin Park Medical Center	Baldwin Park	California
United States	Frederick Regional Health System James M Stockman Cancer Institute	Baltimore	Maryland
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	JHU Sidney Kimmel Comprehensive Cancer Center LAPS	Baltimore	Maryland
United States	MedStar Franklin Square Medical Center Winberg Cancer Institute	Baltimore	Maryland
United States	MedStar Good Samaritan Hospital	Baltimore	Maryland
United States	Medstar Union Memorial Hospital	Baltimore	Maryland
United States	Mercy Medical Center	Baltimore	Maryland
United States	Eastern Maine Medical Center d/b/a Northern Light Cancer Institute	Bangor	Maine
United States	Kaiser Permanente Bellflower Medical Center	Bellflower	California
United States	Maryland Oncology Hematology PA	Bethesda	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center - Einstein Campus	Bronx	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Physicians' Clinic of Iowa PC	Cedar Rapids	Iowa
United States	CAMC Cancer Center	Charleston	West Virginia
United States	Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina
United States	The Charlotte-Mecklenburg Hospital Authority	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago Cancer Center LAPS	Chicago	Illinois
United States	University of Illinois	Chicago	Illinois
United States	Morton Plant Hospital	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Cleveland Clinic Cancer Center/Fairview Hospital	Cleveland	Ohio
United States	Lexington Medical Center/Lexington Oncology Associates	Columbia	South Carolina
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	New Hampshire Oncology-Hematology PA, Concord	Concord	New Hampshire
United States	Mary Imogene Bassett Hospital	Cooperstown	New York
United States	Cancer Care Specialist of Central Illinois	Decatur	Illinois
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Western States Cancer Research NCORP	Denver	Colorado
United States	Iowa Oncology Research Assoc	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates - Des Moines	Des Moines	Iowa
United States	Essentia Health NCORP	Duluth	Minnesota
United States	Hematology & Oncology Associates of Northeastern PA	Dunmore	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	Hematology Oncology Associates of Central New York - East Syracuse	East Syracuse	New York
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	NorthShore University Health System - Evanston Hospital	Evanston	Illinois
United States	Inova Schar Cancer Institute	Fairfax	Virginia
United States	Kaiser Permanente Fontana Medical Center	Fontana	California
United States	Cancer Research Consortium of West Michigan NCORP	Grand Rapids	Michigan
United States	Spectrum Health Butterworth Research Pharmacy	Grand Rapids	Michigan
United States	HSHS Saint Vincent Hospital	Green Bay	Wisconsin
United States	Marin Cancer Care	Greenbrae	California
United States	Marin Cancer Center	Greenbrae	California
United States	Cone Health Cancer Center	Greensboro	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Kaiser Permanente Harbor City Medical Center	Harbor City	California
United States	Hartford Hospital	Hartford	Connecticut
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Penn State Milton S Hershey Medical Center	Hershey	Pennsylvania
United States	New Hampshire Oncology-Hematology PA	Hooksett	New Hampshire
United States	Solinsky Center for Cancer Care	Hooksett	New Hampshire
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	Indiana University - Melvin and Bren Simon Cancer Center LAPS	Indianapolis	Indiana
United States	Kaiser Permanente Irvine Medical Center	Irvine	California
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Queens Hospital Center	Jamaica	New York
United States	Joliet Oncology Hematology Associates Limited	Joliet	Illinois
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Kinston Medical Specialists, PA	Kinston	North Carolina
United States	Gunderson Lutheran Medical Center	La Crosse	Wisconsin
United States	UCSD Moores Cancer Center	La Jolla	California
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Doctors Hospital of Laredo	Laredo	Texas
United States	Cancer Centers of Southwest Oklahoma Research	Lawton	Oklahoma
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Norris Cotton Cancer Center - Nashua	Lebanon	New Hampshire
United States	University of Kentucky-Markey Cancer Center	Lexington	Kentucky
United States	Nebraska Hematology and Oncology	Lincoln	Nebraska
United States	Southeast Nebraska Cancer Center	Lincoln	Nebraska
United States	Trinity Health Michigan	Livonia	Michigan
United States	Long Beach Memorial Medical Center - Todd Cancer Institute	Long Beach	California
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Kaiser Permanente Sunset Medical Center	Los Angeles	California
United States	Norton Cancer Institute - Brownsboro	Louisville	Kentucky
United States	Lowell General Hospital	Lowell	Massachusetts
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Cleveland Clinic Cancer Center/Hillcrest Hospital	Mayfield Heights	Ohio
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	Columbia St. Mary's Water Tower Medical Commons	Milwaukee	Wisconsin
United States	Wheaton Franciscan Healthcare - St. Joseph	Milwaukee	Wisconsin
United States	Southern Cancer Center PC - Providence	Mobile	Alabama
United States	University of South Alabama Mitchell Cancer Institute	Mobile	Alabama
United States	IU Health Ball Memorial Hospital	Muncie	Indiana
United States	Nashville General Hospital at Meharry	Nashville	Tennessee
United States	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee
United States	Memorial Sloan Cancer Center - Hartford Healthcare Center Institute at HOCC	New Britain	Connecticut
United States	Rutgers Cancer Center Institute of New Jersey	New Brunswick	New Jersey
United States	Northwell Health NCORP	New Hyde Park	New York
United States	Ochsner Medical Center	New Orleans	Louisiana
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	Christiana Health System - Christiana Hospital	Newark	Delaware
United States	Kaiser Permanente Oakland Medical Center	Oakland	California
United States	Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Cancer Alliance of Nebraska	Omaha	Nebraska
United States	Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Oneonta FoxCare Center	Oneonta	New York
United States	Advent Health Orlando	Orlando	Florida
United States	Orlando Health Cancer Institute	Orlando	Florida
United States	Palo Alto Medical Foundation Health Care	Palo Alto	California
United States	Kaiser Permanente Panorama City Medical Center	Panorama City	California
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois
United States	Illinois CancerCare-Peoria	Peoria	Illinois
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic in Arizona	Phoenix	Arizona
United States	First Health of the Carolinas - Moore Regional Hospital	Pinehurst	North Carolina
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Cancer Institute- Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	UPMC MaGee Women's Hospital	Pittsburgh	Pennsylvania
United States	Beth Israel Deaconess Hospital - Plymouth Jordan Club Cancer Center	Plymouth	Massachusetts
United States	Providence Portland Medical Center	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Women & Infants Hospital of Rhode Island	Providence	Rhode Island
United States	Wheaton Franciscan Healthcare-All Saints	Racine	Wisconsin
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	VCU Massey Cancer Center	Richmond	Virginia
United States	Kaiser Permanente Riverside Medical Center	Riverside	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic-Rochester	Rochester	Minnesota
United States	OSF Saint Anthony Medical Center	Rockford	Illinois
United States	Phelps Country Regional Medical Center	Rolla	Missouri
United States	Kaiser Permanente Roseville Medical Center	Roseville	California
United States	Kaiser Permanente Sacramento Medical Center	Sacramento	California
United States	Coborn Cancer Center at Saint Cloud Hospital	Saint Cloud	Minnesota
United States	Mercy Hospital Saint Louis	Saint Louis	Missouri
United States	Missouri Baptist Medical Center	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
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	Tidal Health Peninsula Regional	Salisbury	Maryland
United States	Huntsman Cancer Institute - University of Utah	Salt Lake City	Utah
United States	Kaiser Permanente San Diego Medical Center	San Diego	California
United States	Sharp Memorial Hospital	San Diego	California
United States	University of California	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	Memorial Health University Medical Center	Savannah	Georgia
United States	New England Cancer Specialists - Scarborough	Scarborough	Maine
United States	Holy Cross Hospital	Silver Spring	Maryland
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	NorthShore Hematology Oncology-Libertyville	Skokie	Illinois
United States	Orchard Healthcare Research Inc.	Skokie	Illinois
United States	Robert Wood Johnson University Hospital Somerset	Somerville	New Jersey
United States	Kaiser Permanente South San Francisco Medical Center	South San Francisco	California
United States	Cancer Research for the Ozarks NCORP	Springfield	Missouri
United States	Stanford Women's Cancer Center	Stanford	California
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Carle Cancer Center	Urbana	Illinois
United States	Kaiser Permanente Vallejo Medical Center	Vallejo	California
United States	Kaiser Permanente Walnut Creek Medical Center	Walnut Creek	California
United States	George Washington University Medical Faculty Associates	Washington	District of Columbia
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Covenant Medical Center	Waterloo	Iowa
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	Kaiser Permanente Cadillac Medical Center	West Los Angeles	California
United States	Kaiser Permanente Woodland Hills Medical Center	Woodland Hills	California
United States	Reading Hospital/McGlinn Cancer Institute	Wyomissing	Pennsylvania
United States	WellSpan Health York Cancer Center	York	Pennsylvania

Sponsors (6)

Lead Sponsor	Collaborator
Alliance Foundation Trials, LLC.	Austrian Breast & Colorectal Cancer Study Group, Breast International Group, NSABP Foundation Inc, Pfizer, PrECOG, LLC.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive Disease Free Survival (iDFS)	Invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, second primary invasive cancer of non-breast origin or death from any cause. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported.	4 years
Secondary	Invasive Disease Free Survival (iDFS) Excluding Second Primary Invasive Cancers of Non-breast Origin.	Invasive disease-free survival (iDFS, excluding second primary invasive cancers of non-breast origin) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS excluding second primary invasive cancers of non-breast origin is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, or death from any cause. Second primary invasive cancers of non-breast origin will not be considered as events for this endpoint. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported.	4 years
Secondary	Distant Recurrence-free Survival (DRFS)	Compare time to distant recurrence-free survival (DRFS). Distant recurrence is defined according to STEEP criteria as the time from randomization to the date of the first event: distant recurrence or death from any cause. Patients with a locoregional recurrence will continue to be followed for DRFS. Surviving patients who are event-free will be censored at: the date of last disease assessment, or withdrawal of consent to be followed, or death whichever came first. Direct comparison between arms used time to DRFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered DRFS at 4 years is reported.	4 years
Secondary	Overall Survival (OS)	Compare overall survival (OS). Overall survival is defined as the time period between randomization and death. Surviving patients classified as lost-to-follow up or having withdrawn consent to be followed will be censored at their date of last contact or withdrawal of consent to be followed, whichever occurs first.	4 years
Secondary	Locoregional Recurrences-free Survival (LRRFS)	Compare locoregional recurrence-free survival (LRRFS). LRRFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, or death from any cause. Patients with second primary invasive cancers of non-breast origin or distant recurrence will be censored at the date of diagnosis. Surviving patients who are event-free will be censored at: the date of last disease assessment, or withdrawal of consent to be followed, whichever occurs first.	4 years