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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00878709
Other study ID # 3144A2-3004 / B1891004
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 9, 2009
Est. completion date October 4, 2019

Study information

Verified date May 2021
Source Puma Biotechnology, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.


Recruitment information / eligibility

Status Completed
Enrollment 2840
Est. completion date October 4, 2019
Est. primary completion date August 21, 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease. - Been treated for early breast cancer with standard of care duration of trastuzumab. - Could have been treated neoadjuvantly but have not reached pathologic complete response. Exclusion Criteria: - Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry. - History of heart disease. - Corrected QT (QTc) interval >0.45 seconds - History of gastrointestinal disease with diarrhea as the major symptom.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
neratinib

Other:
placebo


Locations

Country Name City State
Australia The Queen Elizabeth Hospital Adelaide South Australia
Australia Ashford Cancer Centre Research Kurralta Park South Australia
Australia Royal Melbourne Hospital Melbourne Victoria
Australia The Western Hospital Melbourne Victoria
Australia Hollywood Private Hospital Nedlands Western Australia
Australia North Adelaide Oncology Calvary Hospital North Adelaide North Adelaide South Australia
Australia Iron Cancer Care South Brisbane South Brisbane Queensland
Australia Sydney West Cancer Trials Centre Sydney New South Wales
Bahamas Affinity Research Limited Nassau
Belgium OLVZ Medische Oncologie Aalst
Belgium Az. St. Jan Brugge
Belgium Cliniques Universitaires de Bruxelles Bruxelles
Belgium VZW Jesseziekenhuis - Campus Virga Jesse Hasselt
Belgium Jan Yperman Ziekenhuis Ieper
Belgium AZ Groeninge ampus Maria's Voorzienigheid (MV) Oncologisch Centrum Kortrijk
Belgium Centre Hospitalier Regional de La Citadelle Liege
Belgium CHU de Liège - Domaine Universitaire du Sart Tilman Liège
Belgium C.H.U. Ambroise Paré Mons
Belgium AZ Damiaan - Site Sint-Jozef Oostende
Belgium AZ Zusters van Barmhartigheid Ronse
Belgium AZ Nikolaas Sint Niklaas
Belgium Sint-Elisabethziekenhuis Turnhout
Brazil Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul Porto Alegre RS
Bulgaria District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD, Ist Plovdiv
Bulgaria District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD, Second Plovdiv
Bulgaria District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD Sofia
Bulgaria Specialised Hospital of Active Treatment in Oncology Sofia
Bulgaria Interdistrict Dispensary for Oncology Diseases Varna
Canada Cross Cancer Institute Edmonton Alberta
Canada Jack Ady Cancer Centre Lethbridge Alberta
Canada London Regional Cancer Program London Ontario
Canada C.H.U.M. - Hopital Notre-Dame, Departement d'Oncologie Montreal Quebec
Canada Hopital du Sacre-Coeur de Montreal Montreal Quebec
Canada Hopital Maisonneuve Rosemont Montreal Quebec
Canada Stronach Regional Cancer Centre at Southlake Newmarket Ontario
Canada R.S. McLaughlin Durham Regional Cancer Centre Oshawa Ontario
Canada Centre Hospitalier Affilie Universitaire de Quebec Hopital du St-Sacrement Quebec
Canada CSSS Alphonse-Desjardins Quebec
Canada University Health Network, Princess Margaret Hospital Toronto Ontario
Canada BC Cancer Agency Vancouver British Columbia
Canada Humber River Regional Hospital - Church Street Site Weston Ontario
Canada CancerCare Manitoba Winnipeg Manitoba
China Cancer Hospital, Chinese Academy of Medical Sciences Beijing
China Chinese People's Liberation Army General Hospital Beijing
China Peking Union Medical College Hospital of Chinese Academy of Medical Sciences Beijing
China The Hospital Affiliated Academy Military Medical Science, Chinese People's Beijing
China Southern Medical University Nanfang Hospital Guangzhou
China Sun Yat-Sen University Cancer Center Guangzhou
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China Fudan University Shanghai Cancer Center Shanghai
China Tianjin Cancer Hospital Tianjin
Colombia Administradora Country S.A-Clinica del Country Bogota
Colombia Oncomedica S.A. IMAT Monteria Cordoba
Colombia Oncologos del Occidente Pereira Risaralda
Croatia University Hospital Centre Osijek, Department of Radiotherapy and Oncology Osijek
Croatia General Hospital Varazdin Varazdin
Croatia Klinicki bolnicki centar "Sestre Milosrdnice" Zagreb
Croatia University Hospital Center Zagreb Zagreb
Czechia Fakultni nemocnice Brno Brno
Czechia Masarykuv Onkologicky ustav Brno
Czechia Nemocnice Jihlava Jihlava
Czechia Institut Onkologie a Reahabilitace na Plesi Nova Ves pod Plesi
Czechia Multiscan s. r. o. Pardubice
Czechia Fakultni Nemocnice v Motole Praha
Denmark Aalborg Sygehus Aalborg
Denmark Aarhus University Hospital Aarhus C
Denmark Rigshospitalet Copenhagen
Denmark Sydvestjysk Sygehus Esbjerg
Denmark Herlev Hospital Herlev
Denmark Hillerod Hospital Hillerod
Denmark Næstved Sygehus Naestved
Denmark Odense Universitetshospital Odense C
Denmark Roskilde University Hospital Roskilde
Denmark Sygehus Sonderjylland Sonderborg
Denmark Vejle Sygehus Vejle
Denmark Regionshospital Viborg Viborg
France C.H.U. De Bordeaux Saint Andre Bordeaux, Cedex
France Centre François Baclesse Caen
France Centre Hospitalier de Montluçon Clermont-Ferrand
France Centre Georges Francois Leclerc Dijon
France Oncologie department, Hopital albert Michalon Grenoble
France Hopital de Versailles Le Chesnay
France Centre Oscar Lambret Lille
France Institut Curie, Département d'Oncologie Médicale Paris
France Hopital Saint Louis Paris Cedex 10
France Hopital La Pitie-Salpetriere Paris cedex 13
France Service d'Oncologie et de Radiotherapie, Polyclinique Francheville, 38 Perigueux
France Centre Henri Becquerel Rouen, Cedex 1
France Centre Rene Gauducheau Saint Herblain Cedex
France Institute de Cancerologie de la Loire Saint Priest en Jarez
France Pole Hospitalier Mutualiste Saint-Nazaire
France CHU Strasbourg Strasbourg
France Clinique Sainte Anne Centre de Radiothérapie Strasbourg
France CHU Bretonneau Centre Henry Kaplan Tours
France CHU Paul Brousse Villejuif
France Institut Gustave Roussy Villejuif
Germany Marienhospital Aachen
Germany Onkologische Praxis Augsburg
Germany Sozialstiftung Bamberg Klinik fuer Haematologie und Internistische Onkologie Bamberg
Germany Frauenarzt-Zentrum-Zehlendorf Berlin
Germany Onkologische Schwerpunktpraxis Berlin
Germany Onkologische Schwerpunktpraxis Berlin
Germany Praxisklinik Krebsheilkunde fuer Frauen Berlin
Germany Luisenkrankenhaus Duesseldorf
Germany Universitaetsklinikum Duesseldorf, Frauenklinik Duesseldorf
Germany Universitaetsklinikum Duesseldorf Düsseldorf
Germany Facharzt fuer Frauenheilkunde und Geburtshilfe Erfurt
Germany Frauenklinik der J.W. Goethe-Universitaet Frankfurt am Main
Germany Onkologische Gemeinschaftspraxis Frankfurt Frankfurt am Main
Germany Staedtische Kliniken Frankfurt am Main-Hoechst Frauenklinik Frankfurt am Main
Germany Praxis für interdisziplinaere Onkologie & Haematologie GbR Freiburg
Germany Klinikum St. Georg/Franziskus, Abteilung fuer Senologie Georgsmarienhuette
Germany Kreiskrankenhaus Hameln, Onkologische Ambulanz Hameln
Germany Facharzt fuer Frauenheilkunde Hannover
Germany Nationales Centrum fuer Tumorerkrankungen Heidelberg
Germany Onkologische Schwerpunktpraxis Heidelberg
Germany Klinikum Kempten - Oberallgaeu Kempten
Germany MTV Abts & Partner Kiel Kiel
Germany Universitaetsfrauenklinikum Schleswig-Holstein Luebeck
Germany Universitaetsklinikum Magdeburg A.oe.R. Magdeburg
Germany Klinikum der Johannes-Gutenberg-Universitaet Mainz
Germany Fachpraxis fuer Innere Medizin Muenchen
Germany Klinik und Poliklinik fuer Muenchen
Germany Praxis Gynaekologie Arabella Muenchen Muenchen
Germany Klinik fuer Gynaekologie und Geburtshilfe Offenbach
Germany Klinikum Oldenburg GmbH Oldenburg
Germany Pius-Hospital Oldenburg Oldenburg
Germany Oncologianova GmbH Recklinghausen
Germany Universitaetsfrauenklinik Tuebingen Tuebingen
Germany St. Marienhospital Vechta Vechta
Germany Gemeinschaftspraxis fuer Haematologie und Onkologie Westerstede
Germany Klinik für Gynaekologie und gyn. Onkologie Wiesbaden
Germany Marienhospital Witten Witten
Greece University General Hospital of Alexandroupoli, Department of Medical Oncology Alexandroúpoli
Greece Hippokratio General Hospital of Athens Athens
Greece Hippokration Hospital Athens Athens
Greece General Hospital of Chania Ag. Georgios Chania Crete
Greece University Hospital of Heraklion Heraklion Creete
Greece University General Hospital of Larissa Larissa
Greece University Hospital of Patras Rio Patras
Greece Euromedica General Clinic Thessaloniki
Hong Kong Department of Clinical Oncology, Tuen Mun Hospital Hong Kong
Hong Kong Queen Mary Hospital, Department of Clinical Oncology, Professorial Block Hong Kong
Hong Kong Queen Mary Hospital, Department of Medicine Hong Kong
Hong Kong Queen Mary Hospital, Department of Medicine, Blk K Hong Kong
Hong Kong UNIMED Medical Institute, Comprehensive Centre for Breast Diseases Hong Kong Wanchai
Hungary Fovarosi Onkormanyzat Szent Imre Korhaz Budapest
Hungary Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly Budapest
Hungary Semmelweis Egyetem Radiologiai és Onkoterapias Klinika Budapest
Hungary Bekes M. Kepviselotest. Pandy Kalman Korhaz, Megyei Onkol. Kp., Klin. Onkol. es Sugartherapias Oszt. Gyula
Hungary Kaposi Mor Oktato Korhaz, Onkologiai Centrum Kaposvar
Hungary Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont Kecskemet
Hungary Borsod-Abauj-Zemplen M. Korhaz es Egyetemi Okt. K., Klin. Onk., Sugarterapias es Kozp. Szuro Centrum Miskolc
Hungary Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft. / Onkoradiologiai Osztaly Nyiregyhaza
Hungary Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt. Veszprem
Israel Soroka University MC, Department of Oncology Beer Sheva
Israel Rambam Health care campus, Oncology institute Haifa
Israel Kaplan Medical Center, Department of Oncology Rehovot
Israel Sheba Medical Center, Oncology Institute Tel Hashomer Tel Hashomer
Italy Azienda Ospedaliera San Giuseppe Moscati Avellino
Italy Presidio Ospedaliero di Summa - Antonio Perrino Brindisi
Italy Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele" Catania
Italy Fondazione per la Ricerca e la Cura dei Tumori Tommaso Campanella Catanzaro
Italy Azienda Ospedaliera San Gerardo Monza
Italy Fondazione Giovanni Pascale Napoli
Italy Unita' Operativa Complessa Oncologia Medica, A.O.R.N. "Cardarelli" Napoli
Italy Azienda Ospedaliera San Luigi Gonzaga Orbassano (TO)
Italy IRCCS Istituto Oncologico Veneto di Padova Padova
Italy Azienda Ospedaliero-Universitaria Pisana Pisa
Italy Azienda Ospedaliera Bianchi Melacrino Morelli Reggio Calabria
Italy Oncologia Medica A, Istituti Fisioterapici Ospitalieri Roma
Italy Ospedale San Pietro Fatebenefratelli Roma
Italy Universita Campus Bio-Medico Roma
Italy Ospedale SS Trinita Sora (FR)
Italy Azienda Ospedaliera S. Maria Terni
Italy Ospedale Treviglio e Caravaggio, UO Oncologia Medica Treviglio, BG
Italy Istituto Oncologico del Mediterraneo Viagrande (CT)
Italy Ospedale Belcolle Viterbo Viterbo
Japan Aichi Cancer Center Aichi
Japan Chiba Cancer Center Chiba
Japan National Cancer Center Hospital East Chiba
Japan National Hospital Organization Shikoku Cancer Center Ehime
Japan Kurume Daiichi Social Insurance Hospital Fukuoka
Japan National Hospital Organization Kyushu Cancer Center Fukuoka
Japan Hiroshima City Hospital Hiroshima
Japan National Hospital Organization Hokkaido Cancer Center Hokkaido
Japan Hyogo Cancer Center Hyogo
Japan Hakuaikai Medical Corporation Sagara Hospital Kagoshima
Japan Kanagawa Cancer Center Kanagawa
Japan Tokai University Hospital Kanagawa
Japan Kumamoto Municipal Hospital Kumamoto
Japan Kyoto University Hospital Kyoto
Japan Niigata Cancer Center Hospital 2-15-3 Niigata
Japan National Hospital Organization Osaka National Hospital Osaka
Japan Osaka Medical Center for Cancer and Cardiovascular Diseases Osaka
Japan Osaka University Hospital Osaka
Japan Saitama Cancer Center Saitama
Japan Shizuoka Cancer Center Shizuoka
Japan Jichi Medical University Hospital Tochigi
Japan The Cancer Institute Hospital of Japanese Foundation for Cancer Research Tokyo
Japan Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hp Tokyo
Korea, Republic of National Cancer Center, Center for Breast Cancer Gyeonggi-do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Korea University Anam Hospital, Department of Oncology/Hematology Seoul
Korea, Republic of Samsung Medical Center Seoul Korea
Korea, Republic of Seoul National University Hospital, Department of Internal Medicine Seoul
Lithuania The Hospital of Lithuanian University of Health Sciences Kauno klinikos Oncology and Haematology Clinic Kaunas
Lithuania Oncology Institute of Vilnius University Vilnius
Malaysia University Malaya Medical Centre Kuala Lumpur
Malta Sir Paul Boffa Hospital Floriana
Mexico Nucleo de Especialidades Oncológicas Guadalajara Jalisco
Netherlands Ziekenhuis Amstelland Amstelveen
Netherlands Gelre ZH Apeldoorn
Netherlands Amphia Ziekenhuis - Interne Geneeskunde Breda
Netherlands Haga Ziekenhuis Den Haag
Netherlands Maxima Medisch Centrum Eindhoven
Netherlands Vlietland Ziekenhuis Schiedam
Netherlands Orbis Medisch Centrum Sittard-Geleen
New Zealand Auckland Hospital Auckland
North Macedonia University Clinic for Radiotherapy and Oncology Skopje
Peru Clínica Vista Alegre / Unidad de Investigacion Surco Lima
Poland Bialostockie Centrum Onkologii im. M. Sklodowskiej- Curie w Bialymstoku Bialystok
Poland Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdrowotnej "Magodent" Bydgoszcz
Poland Centrum Onkologii im. prof. Franciszka Lukaszczyka Bydgoszcz
Poland Uniwersyteckie Centrum Kliniczne w Gdansku Gdansk
Poland Szpital Morski im. PCK Gdynskie Centrum Onkologii Oddzial Chemioterapii Gdynia
Poland Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial Jelenia Gora
Poland Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakow
Poland Olsztynski Osrodek Onkologiczny Kopernik Sp. z o.o. Olsztyn
Poland Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w Olsztyn
Poland Szpital Wojewodzki im. Sw. Lukasza Samodzielny Publiczny Zaklad Opieki Tarnow
Poland Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdrowotnej "Magodent" Warszawa
Romania Spitalul Universitar de Urgenta Bucuresti Bucuresti
Romania Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca Cluj
Romania SC Oncolab S.R.L. Craiova Dolj
Serbia Institute of Oncology and Radiology of Serbia Belgrade
Serbia Clinical centre Nis Nis
Singapore National Cancer Centre Singapore Singapore
Slovakia Interna onkologicka klinika Bratislava
Slovakia Oddelenie radioterapie a onkologie Kosice
Slovakia Poliklinika ADUS Poprad
Spain Centro Oncologico de Galicia A Coruna
Spain Hospital Universitario Fundacion de Alcorcon Alcorcon Madrid
Spain Hospital Universitari Germans Trias i Pujol Badalona Barcelona
Spain Hospital de Barbastro Barbastro Huesca
Spain Hospital Clinic i Provincial de Barcelona Barcelona
Spain Hospital Universitario Vall D´Hebron Barcelona
Spain Hospital De Basurto Bilbao Vizcaya
Spain Hospital San Pedro de Alcantara Caceres
Spain Hospital Universitario Puerta del Mar Cadiz
Spain Consorcio Hospitalario Provincial de Castellon Castellon
Spain Hospital Universitario Reina Sofia Cordoba
Spain Hospital General Universitario de Elche Elche Alicante
Spain ICO de Girona - Hospital Universitario de Girona Dr. Josep Trueta Girona
Spain Hospital Universitario de Guadalajara Guadalajara
Spain ICO de Barcelona - Hospital Duran i Reynals, Hospitalet de Llobregat Consorci Sanitari de Terrassa Hospitalet de Llobregat Barcelona
Spain Complejo Hospitalario de Jaen Jaen
Spain Hospital Universitario de Canarias La Laguna Santa Cruz De Tenerife
Spain Hospital Universitario Insular de Gran Canaria Las Palmas de Gran Canaria
Spain Hospital Universitari Arnau de Vilanova de Lleida Lleida
Spain Hospital Clinico San Carlos Madrid
Spain Hospital General Universitario Gregorio Marañon Madrid
Spain Hospital Madrid Norte Sanchinarro. Centro Integral Oncologico Clara Campal Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Hospital Puerta de Hierro-Majadahonda Majadahonda Madrid
Spain Hospital Clinico Universitario Virgen de La Victoria Malaga
Spain Hospital Universitari Son Espases Palma de Mallorca Islas Baleares
Spain Hospital Universitario Nuestra Señora de Candelaria Santa Cruz de Tenerife
Spain Hospital Universitario Virgen del Rocio Sevilla
Spain Consorci Sanitari de Terrassa Terrassa Barcelona
Spain Hospital Mutua de Terrassa Terrassa Barcelona
Spain Hospital Virgen de la Salud Toledo
Spain Hospital de Torrevieja Torrevieja Alicante
Spain Fundacion Instituto Valenciano de Oncologia Valencia
Spain Hospital Clinico Universitario de Valencia Valencia
Spain Hospital Provincial de Zamora Zamora
Spain Hospital Universitario Miguel Servet Zaragoza
Sweden Onkologiska Kliniken Lund
Sweden Skanes Onkologiska Kliniken Lund
Switzerland Hirslanden Medical Center Tumor Center Aarau
Switzerland Kantonsspital Baden Baden
Switzerland Kantonsspital Olten-Medizinische Onkologie Olten
Switzerland Spital STS AG Thun
Taiwan Kaohsiung Medical University Chung-Ho memorial Hospital Kaohsiung
Taiwan Chang Gung Medical Foundation, Linkou Branch Kwei-Shan, Taoyuan
Taiwan National Taiwan University Hospital Taipei TOC
Turkey Gazi Universitesi Tip Fakultesi Besevler/Ankara
Turkey Ege Universitesi Tip Fakultesi Bornova/Izmir
Turkey Istanbul Universitesi Istanbul Tip Fakultesi Capa/Istanbul
Turkey Istanbul Universitesi Cerrahpasa Tip Fakultesi, Ic Hastaliklari Anabilim Dali Cerrahpasa/Istanbul
Turkey Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Demetevler/Ankara
Turkey Uludag Universitesi Tip Fakultesi Gorukle/Bursa
Turkey Dokuz Eylul Universitesi Tip Fakultesi Inciralti/Izmir
Turkey Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi Istanbul
Turkey Gaziantep Universitesi Sehitkamil/Gaziantep
Turkey Hacettepe Universitesi Tip Fakultesi Sihhiye/Ankara
United Kingdom Queens Hospital Burton-on-Trent Staffs
United Kingdom St James's University Hospital Leeds
United Kingdom University Hospitals of Leicester Leicester
United Kingdom Charing Cross Hospital, Department Of Medical Oncology London
United Kingdom Guy's Hospital London
United Kingdom St. Bartholomew's Hospital London
United Kingdom Christie Hospital Manchester
United Kingdom Norfolk & Norwich University Hospitals Norwich
United Kingdom Nottingham City Hospital Nottingham
United Kingdom Betsi Cadwaladr University Health Board Rhyl Denbighshire
United Kingdom Weston Park Hospital Sheffield
United Kingdom Singleton Hospital Swansea
United Kingdom Southend University Hospital Westcliff-on-Sea
United States Phoebe Cancer Center Albany Georgia
United States Anniston Oncology Anniston Alabama
United States Ashland-Bellefonte Cancer Center Ashland Kentucky
United States Piedmont Cancer Institute Atlanta Georgia
United States Augusta Oncology Associates (ACORN), P.C. Augusta Georgia
United States Texas Oncology, P.A. Austin Texas
United States Innovative Medical Research of South Florida, Inc. Aventura Florida
United States Harry and Jeanette Weinberg Cancer Center Baltimore Maryland
United States Medical Oncology & Hematology Mercy Medical Center Baltimore Maryland
United States Hematology-Oncology Clinic Baton Rouge Louisiana
United States Texas Oncology, P.A. Bedford Texas
United States Bend Memorial Clinic Bend Oregon
United States Southwestern Vermont Regional Cancer Center Bennington Vermont
United States Oncology-Hematology of Lehigh Valley, PC Bethlehem Pennsylvania
United States Cedars-Sinai Medical Group Beverly Hills California
United States Birmingham Hematology and Oncology Associates, LLC Birmingham Alabama
United States Mid Dakota Clinic, PC Bismarck North Dakota
United States Massachusetts General Hospital Boston Massachusetts
United States Massachusetts General Hospital - Gillette Center Boston Massachusetts
United States University Cancer Institute, LLC Boynton Beach Florida
United States Eastchester Center for Cancer Care Bronx New York
United States Charleston Hematology Oncology Associates, PA Charleston South Carolina
United States Medical University of South Carolina Hollings Cancer Center Charleston South Carolina
United States University Hematology/Oncology Associates PLLC Chattanooga Tennessee
United States The Center for Cancer and Hematologic Disease Cherry Hill New Jersey
United States Rush University Medical Center Chicago Illinois
United States The Christ Hospital Cancer Center Cincinnati Ohio
United States University of Cincinnati Cincinnati Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States University Hospitals, Cleveland Medical Center Cleveland Ohio
United States Francisco Gonzalez MD PA Columbia South Carolina
United States NorthEast Oncology Associates Carolinas Medical Center NorthEast Concord North Carolina
United States Cookeville Regional Cancer Center Cookeville Tennessee
United States Cancer Specialists of South Texas, P.A. Corpus Christi Texas
United States Coastal Bend Cancer Center Corpus Christi Texas
United States South Texas Institute of Cancer Corpus Christi Texas
United States Samaritan Hematology & Oncology Consultants Corvallis Oregon
United States Center for Oncology Research Dallas Texas
United States Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas
United States Texas Oncology, P.A. Dallas Texas
United States University of Texas Southwestern Medical Center Simmons Cancer Center Dallas Texas
United States Cancer Care Specialists of Illinois, Decatur Memorial Hospital Clinical Research Decatur Illinois
United States North Broward Medical Center Deerfield Beach Florida
United States Texas Oncology, P.A. Denton Texas
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Duke University Medical Center Medical Oncology Durham North Carolina
United States Center for Integrative Cancer Medicine, PA El Paso Texas
United States El Paso Cancer Treatment Center - West El Paso Texas
United States Trinitas Comprehensive Cancer Center Elizabeth New Jersey
United States Inova Schar Cancer Institute Fairfax Virginia
United States Virginia Cancer Specialists, PC Fairfax Virginia
United States McLeod Oncology and Hematology Associates Florence South Carolina
United States Dwight David Eisenhower Army Medical Center Fort Gordon Georgia
United States Broward General Medical Center Fort Lauderdale Florida
United States Texas Oncology Fort Worth Texas
United States Florida Cancer Specialists and Research Institute Gainesville Florida
United States Texas Oncology, P.A. Garland Texas
United States The Jones Clinic, PC Germantown Tennessee
United States Gettysburg Cancer Center Gettysburg Pennsylvania
United States Ronald Yanagihara, M.D. Gilroy California
United States Glendale Adventist Medical Center Cancer Services Glendale California
United States Cancer and Hematology Centers of Western Michigan Grand Rapids Michigan
United States Medical Specialty Associates Grand Rapids Michigan
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States California Cancer Care Greenbrae California
United States Pinnacle Health Cancer Center Community Campus Harrisburg Pennsylvania
United States Beaver Medical Group, L.P. Highland California
United States South Carolina Cancer Specialists Hilton Head Island South Carolina
United States Straub Clinic & Hospital Honolulu Hawaii
United States Jabboury Foundation for Cancer Research, Inc. Houston Texas
United States Medicus Alliance Clinical Research Org., Inc. Houston Texas
United States Texas Oncology - Memorial City Houston Texas
United States The Methodist Hospital Breast Center Houston Texas
United States Central Indiana Cancer Centers Indianapolis Indiana
United States Hematology Oncology of Indiana Indianapolis Indiana
United States Capitol Comprehensive Cancer Care Clinic Jefferson City Missouri
United States Midwest Center for Hematology/Oncology Joliet Illinois
United States Northeast Arkansas Clinic Jonesboro Arkansas
United States Cascade Cancer Center Kirkland Washington
United States Thompson Cancer Survival Center Knoxville Tennessee
United States ProHealth Care Associates Lake Success New York
United States Lakeland Regional Cancer Center Lakeland Florida
United States Central Maine Healthcare Corp Lewiston Maine
United States Southeast Nebraska Hematology & Oncology Consultants, PC Lincoln Nebraska
United States Saint Barnabas Health Care System Livingston New Jersey
United States Breastlink Medical Group Long Beach California
United States Long Beach Memorial Medical Center Long Beach California
United States Hematology Oncology Associates Loxahatchee Groves Florida
United States Crescent City Research Consortium, LLC Marrero Louisiana
United States Signal Point Hematology/Oncology, Inc. Middletown Ohio
United States Minnesota Oncology Hematology, PA Minneapolis Minnesota
United States Facey Medical Group Mission Hills California
United States Montana Cancer Specialists Missoula Montana
United States Medical Arts Associates, Ltd Moline Illinois
United States Sweeney-Melenyser Pavillion Monongahela Pennsylvania
United States West Virginia University Mary Babb Randolph Cancer Center Morgantown West Virginia
United States Summit Medical Group Morristown New Jersey
United States Oncology and Hematology Specialist Mountain Lakes New Jersey
United States Community Hospital Munster Indiana
United States Nashville Breast Center Nashville Tennessee
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Jersey Shore University Medical Center Neptune New Jersey
United States Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center New York New York
United States NYU Clinical Cancer Center New York New York
United States Gynecologic Oncology Associates Newport Beach California
United States Advocate Medical Group Niles Illinois
United States Cancer Care & Hematology Specialists of Chicagoland Niles Illinois
United States Virginia Oncology Associates Norfolk Virginia
United States Great Plains Regional Medical Center North Platte Nebraska
United States Florida Cancer Affiliates - Ocala Ocala Florida
United States North Utah Associates Ogden Utah
United States Mercy Physicians of Oklahoma Oklahoma City Oklahoma
United States Mid-Florida Hematology & Oncology Centers, PA Orange City Florida
United States Cancer Centers of Florida Orlando Florida
United States M.D. Anderson Cancer Center Orlando Orlando Florida
United States Ventura County Hematology-Oncology Specialists Oxnard California
United States Purchase Cancer Group Paducah Kentucky
United States The Valley Hospital, Luckow Pavilion Paramus New Jersey
United States Texas Oncology, P.A. Paris Texas
United States Pawtuket Memorial Hospital Pawtucket Rhode Island
United States Northern Michigan Hematology/Oncology Petoskey Michigan
United States Albert Einstein Cancer Center Philadelphia Pennsylvania
United States Perelman Center for Advanced Medicine Philadelphia Pennsylvania
United States Temple University Hospital Philadelphia Pennsylvania
United States Thomas Jefferson University Philadelphia Pennsylvania
United States Arizona Oncology Associates, PC - HAL Phoenix Arizona
United States Florida Cancer Research Institute Plantation Florida
United States Portneuf Medical Center Pocatello Idaho
United States Hematology Oncology Associates of Treasure Coast Port Saint Lucie Florida
United States Kaiser Permanente Northwest Region Oncology Hematology Portland Oregon
United States Mercy Hospital Oncology/Hematology Center Portland Maine
United States Northwest Cancer Specialist, P.C. Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States Providence Cancer Center Oncology and Hematology Care - Westside Portland Oregon
United States Quincy Medical Group, Cancer Center at Blessing Hospital Quincy Illinois
United States Wheaton Franciscan Cancer Care-All Saints Racine Wisconsin
United States Raleigh Hematology Oncology Associates Cancer Centers of North Carolina Raleigh North Carolina
United States Desert Hematology Oncology Medical Group, Inc Rancho Mirage California
United States Rutland Regional Medical Center Rutland Vermont
United States St. Joseph's Oncology Saint Joseph Missouri
United States Washington University School of Medicine Siteman Cancer Center Saint Louis Missouri
United States Park Nicollet Institute Saint Louis Park Minnesota
United States Florida Cancer Specialists, P.L. Saint Petersburg Florida
United States Utah Cancer Specialists Salt Lake City Utah
United States Cancer Care Centers of South Texas San Antonio Texas
United States South Texas Oncology & Hematology San Antonio Texas
United States Helen Diller Family University of California San Francisco Comprehensive Cancer Center San Francisco California
United States San Francisco Oncology Associates San Francisco California
United States Redwood Regional Medical Group Santa Rosa California
United States Guthrie Clinic, Limited Sayre Pennsylvania
United States Arizona Oncology Associates, PC - NAHOA Sedona Arizona
United States Avera Medical Oncology and Hematology - Avera Cancer Institute Sioux Falls South Dakota
United States North Shore Cancer Research Associates Skokie Illinois
United States Orchard Healthcare Research, Inc. Skokie Illinois
United States Orchard Research, LLC Skokie Illinois
United States The Cancer Prevention and Treatment Center Soquel California
United States Cancer Center of Central Connecticut Southington Connecticut
United States Cancer Care Northwest-North Spokane Washington
United States Mercy Medical Research Institute Springfield Missouri
United States Simmons Cancer Institute Springfield Illinois
United States Springfield Clinic, LLP Springfield Illinois
United States Willamette Valley Cancer Institute and Research Center Springfield Oregon
United States Hematology Oncology, PC Stamford Connecticut
United States Texas Oncology P.A. Sugar Land Texas
United States Santee Hematology Oncology Sumter South Carolina
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Oncology and Hematology of West Broward Tamarac Florida
United States Connecticut Oncology and Hematology Torrington Connecticut
United States Arizona Cancer Center Tucson Arizona
United States Arizona Oncology Associates Tucson Arizona
United States North Mississippi Hematology and Oncology Associates, Ltd. Tupelo Mississippi
United States East Texas Medical Center Cancer Institute Tyler Texas
United States Texas Oncology Tyler Texas
United States Cooper University Hospital Voorhees New Jersey
United States Texas Oncology Cancer Care and Research Center Waco Texas
United States Washington Cancer Institute at Washington Hospital Center Washington District of Columbia
United States Wenatchee Valley Medical Center Wenatchee Washington
United States Alliance Hematology Oncology, PA Carroll County Cancer Center Westminster Maryland
United States Wheeling Hospital Wheeling West Virginia
United States Abington Hematology Oncology Associates, Inc Willow Grove Pennsylvania
United States Hanover Medical Specialists, PA Wilmington North Carolina
United States University of Massachusetts Memorial Medical Center Worcester Massachusetts
United States York Hospital Oncology Treatment Center York Maine
United States Florida Medical Clinic, P.A. Zephyrhills Florida
United States Midwestern Regional Medical Center Zion Illinois

Sponsors (1)

Lead Sponsor Collaborator
Puma Biotechnology, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Bahamas,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Colombia,  Croatia,  Czechia,  Denmark,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Lithuania,  Malaysia,  Malta,  Mexico,  Netherlands,  New Zealand,  North Macedonia,  Peru,  Poland,  Romania,  Serbia,  Singapore,  Slovakia,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 5 Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause. From randomization until time of event up to 5 years
Other Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 5 by Treatment Arms From randomization until time of event up to 5 years
Other Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 5 Disease-free survival including DCIS time is defined as the time from date of randomization until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any. From randomization until time of event up to 5 years
Other Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 5 Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause. From randomization until time of event up to 5 years
Other Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 5 Percentage of Participants with TTDR events is reported. TTDR is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer. From randomization until time of event up to 5 years
Other Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 5 Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988). From randomization until time of event up to 5 years
Primary Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause. From randomization until time of event up to 2 years
Primary Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms From randomization until time of event up to 2 years
Secondary Overall Survival (OS) OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Randomization until death due to any cause (up to 119 Months)
Secondary Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 2 Disease-free survival including DCIS time is defined as the time from date of randomization until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any. From randomization until time of event up to 2 years
Secondary Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms From randomization until time of event up to 2 years
Secondary Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause. From randomization until time of event up to 2 years
Secondary Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms From randomization until time of event up to 2 years
Secondary Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 2 Percentage of Participants with TTDR events is reported. TTDR is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer. From randomization until time of event up to 2 years
Secondary Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms From randomization until time of event up to 2 years
Secondary Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm at Year 2 CNS recurrence is defined as the time from randomization to CNS as the first distant recurrence. Competing events include distant recurrence at other sites as the first distant recurrence and death from any cause prior to distant recurrence. From randomization until time of event up to 2 years
Secondary Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2 Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988). From randomization until time of event up to 2 years
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