Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
ExteNET
A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer
1 other identifier
interventional
2,840
39 countries
492
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Jul 2009
Longer than P75 for phase_3 breast-cancer
492 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2009
CompletedFirst Posted
Study publicly available on registry
April 9, 2009
CompletedStudy Start
First participant enrolled
July 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2014
CompletedResults Posted
Study results publicly available
October 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2019
CompletedJune 11, 2021
May 1, 2021
5.1 years
April 8, 2009
August 10, 2017
May 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (9)
Overall Survival (OS)
Randomization until death due to any cause (up to 119 Months)
Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 2
From randomization until time of event up to 2 years
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
Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 2
From randomization until time of event up to 2 years
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
- +4 more secondary outcomes
Other Outcomes (6)
Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 5
From randomization until time of event up to 5 years
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
Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 5
From randomization until time of event up to 5 years
- +3 more other outcomes
Study Arms (2)
Neratinib
EXPERIMENTAL240 mg orally daily for one year
Placebo
PLACEBO COMPARATORorally daily for one year
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (494)
Anniston Oncology
Anniston, Alabama, 36207, United States
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, 35205, United States
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, 85016, United States
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, 86336, United States
Arizona Oncology Associates
Tucson, Arizona, 85704-7891, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401, United States
Cedars-Sinai Medical Group
Beverly Hills, California, 90211, United States
Ronald Yanagihara, M.D.
Gilroy, California, 95020, United States
Glendale Adventist Medical Center Cancer Services
Glendale, California, 91206, United States
California Cancer Care
Greenbrae, California, 94904, United States
Beaver Medical Group, L.P.
Highland, California, 92346, United States
Breastlink Medical Group
Long Beach, California, 90806, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Facey Medical Group
Mission Hills, California, 91345, United States
Gynecologic Oncology Associates
Newport Beach, California, 92663, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030, United States
Desert Hematology Oncology Medical Group, Inc
Rancho Mirage, California, 92270, United States
Helen Diller Family University of California San Francisco Comprehensive Cancer Center
San Francisco, California, 94115, United States
San Francisco Oncology Associates
San Francisco, California, 94115, United States
Redwood Regional Medical Group
Santa Rosa, California, 95403, United States
The Cancer Prevention and Treatment Center
Soquel, California, 95073, United States
Cancer Center of Central Connecticut
Southington, Connecticut, 06489, United States
Hematology Oncology, PC
Stamford, Connecticut, 06902, United States
Connecticut Oncology and Hematology
Torrington, Connecticut, 06790, United States
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Innovative Medical Research of South Florida, Inc.
Aventura, Florida, 33180, United States
University Cancer Institute, LLC
Boynton Beach, Florida, 33426, United States
North Broward Medical Center
Deerfield Beach, Florida, 33064, United States
Broward General Medical Center
Fort Lauderdale, Florida, 33316, United States
Florida Cancer Specialists and Research Institute
Gainesville, Florida, 32605, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
Hematology Oncology Associates
Loxahatchee Groves, Florida, 33470, United States
Florida Cancer Affiliates - Ocala
Ocala, Florida, 34471, United States
Mid-Florida Hematology & Oncology Centers, PA
Orange City, Florida, 32763-8316, United States
Cancer Centers of Florida
Orlando, Florida, 32806, United States
M.D. Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Florida Cancer Research Institute
Plantation, Florida, 33324, United States
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, 34592, United States
Florida Cancer Specialists, P.L.
St. Petersburg, Florida, 33705, United States
Oncology and Hematology of West Broward
Tamarac, Florida, 33321, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33542, United States
Phoebe Cancer Center
Albany, Georgia, 31701, United States
Piedmont Cancer Institute
Atlanta, Georgia, 30318, United States
Augusta Oncology Associates (ACORN), P.C.
Augusta, Georgia, 30909, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650, United States
Straub Clinic & Hospital
Honolulu, Hawaii, 96813-3083, United States
Portneuf Medical Center
Pocatello, Idaho, 83201, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Cancer Care Specialists of Illinois, Decatur Memorial Hospital Clinical Research
Decatur, Illinois, 62526, United States
Midwest Center for Hematology/Oncology
Joliet, Illinois, 60432, United States
Medical Arts Associates, Ltd
Moline, Illinois, 61265, United States
Advocate Medical Group
Niles, Illinois, 60714, United States
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, 60714, United States
Quincy Medical Group, Cancer Center at Blessing Hospital
Quincy, Illinois, 62301, United States
North Shore Cancer Research Associates
Skokie, Illinois, 60076, United States
Orchard Healthcare Research, Inc.
Skokie, Illinois, 60076, United States
Orchard Research, LLC
Skokie, Illinois, 60076, United States
Simmons Cancer Institute
Springfield, Illinois, 62702, United States
Springfield Clinic, LLP
Springfield, Illinois, 62702, United States
Midwestern Regional Medical Center
Zion, Illinois, 60099, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, 46219, United States
Hematology Oncology of Indiana
Indianapolis, Indiana, 46260-2082, United States
Community Hospital
Munster, Indiana, 46321, United States
Ashland-Bellefonte Cancer Center
Ashland, Kentucky, 41101-7016, United States
Purchase Cancer Group
Paducah, Kentucky, 42001, United States
Hematology-Oncology Clinic
Baton Rouge, Louisiana, 70809, United States
Crescent City Research Consortium, LLC
Marrero, Louisiana, 70072, United States
Central Maine Healthcare Corp
Lewiston, Maine, 04240, United States
Mercy Hospital Oncology/Hematology Center
Portland, Maine, 04102, United States
York Hospital Oncology Treatment Center
York Village, Maine, 03909, United States
Medical Oncology & Hematology Mercy Medical Center
Baltimore, Maryland, 21202, United States
Harry and Jeanette Weinberg Cancer Center
Baltimore, Maryland, 21237, United States
Alliance Hematology Oncology, PA Carroll County Cancer Center
Westminster, Maryland, 21157, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Massachusetts General Hospital - Gillette Center
Boston, Massachusetts, 02215, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-2013, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503, United States
Medical Specialty Associates
Grand Rapids, Michigan, 49503, United States
Northern Michigan Hematology/Oncology
Petoskey, Michigan, 49770, United States
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, 55404, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, 55426, United States
North Mississippi Hematology and Oncology Associates, Ltd.
Tupelo, Mississippi, 38801, United States
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, 65109, United States
St. Joseph's Oncology
Saint Joseph, Missouri, 64507, United States
Mercy Medical Research Institute
Springfield, Missouri, 65807, United States
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, 63110, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Southeast Nebraska Hematology & Oncology Consultants, PC
Lincoln, Nebraska, 68510, United States
Great Plains Regional Medical Center
North Platte, Nebraska, 69101, United States
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003, United States
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, 07207, United States
Saint Barnabas Health Care System
Livingston, New Jersey, 07039, United States
Summit Medical Group
Morristown, New Jersey, 07960, United States
Oncology and Hematology Specialist
Mountain Lakes, New Jersey, 07046, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754, United States
The Valley Hospital, Luckow Pavilion
Paramus, New Jersey, 07652, United States
Cooper University Hospital
Voorhees Township, New Jersey, 08043-4689, United States
ProHealth Care Associates
Lake Success, New York, 11042, United States
NYU Clinical Cancer Center
New York, New York, 10016, United States
Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Eastchester Center for Cancer Care
The Bronx, New York, 10469, United States
NorthEast Oncology Associates Carolinas Medical Center NorthEast
Concord, North Carolina, 28025, United States
Duke University Medical Center Medical Oncology
Durham, North Carolina, 27710, United States
Raleigh Hematology Oncology Associates Cancer Centers of North Carolina
Raleigh, North Carolina, 27607, United States
Hanover Medical Specialists, PA
Wilmington, North Carolina, 28401, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, 58501, United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Signal Point Hematology/Oncology, Inc.
Middletown, Ohio, 45042, United States
Mercy Physicians of Oklahoma
Oklahoma City, Oklahoma, 73120, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
Samaritan Hematology & Oncology Consultants
Corvallis, Oregon, 97330, United States
Northwest Cancer Specialist, P.C.
Portland, Oregon, 97213, United States
Providence Cancer Center Oncology and Hematology Care - Westside
Portland, Oregon, 97213, United States
Kaiser Permanente Northwest Region Oncology Hematology
Portland, Oregon, 97227-1110, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, 97477, United States
Oncology-Hematology of Lehigh Valley, PC
Bethlehem, Pennsylvania, 18015, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Pinnacle Health Cancer Center Community Campus
Harrisburg, Pennsylvania, 17109, United States
Sweeney-Melenyser Pavillion
Monongahela, Pennsylvania, 15063, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141, United States
Guthrie Clinic, Limited
Sayre, Pennsylvania, 18840, United States
Abington Hematology Oncology Associates, Inc
Willow Grove, Pennsylvania, 19090-1137, United States
Pawtuket Memorial Hospital
Pawtucket, Rhode Island, 02860, United States
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29414, United States
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Francisco Gonzalez MD PA
Columbia, South Carolina, 29203, United States
McLeod Oncology and Hematology Associates
Florence, South Carolina, 29506, United States
South Carolina Cancer Specialists
Hilton Head Island, South Carolina, 29926, United States
Santee Hematology Oncology
Sumter, South Carolina, 29150, United States
Avera Medical Oncology and Hematology - Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
University Hematology/Oncology Associates PLLC
Chattanooga, Tennessee, 37403, United States
Cookeville Regional Cancer Center
Cookeville, Tennessee, 38501, United States
The Jones Clinic, PC
Germantown, Tennessee, 38138, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Nashville Breast Center
Nashville, Tennessee, 37203, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Texas Oncology, P.A.
Austin, Texas, 78731, United States
Texas Oncology, P.A.
Bedford, Texas, 76022, United States
Coastal Bend Cancer Center
Corpus Christi, Texas, 78404, United States
South Texas Institute of Cancer
Corpus Christi, Texas, 78405, United States
Cancer Specialists of South Texas, P.A.
Corpus Christi, Texas, 78412, United States
Center for Oncology Research
Dallas, Texas, 75230, United States
Texas Oncology, P.A.
Dallas, Texas, 75231-4400, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center Simmons Cancer Center
Dallas, Texas, 75390, United States
Texas Oncology, P.A.
Denton, Texas, 76210, United States
El Paso Cancer Treatment Center - West
El Paso, Texas, 79902, United States
Center for Integrative Cancer Medicine, PA
El Paso, Texas, 79912, United States
Texas Oncology
Fort Worth, Texas, 76104, United States
Texas Oncology, P.A.
Garland, Texas, 75042, United States
Texas Oncology - Memorial City
Houston, Texas, 77024, United States
The Methodist Hospital Breast Center
Houston, Texas, 77030, United States
Medicus Alliance Clinical Research Org., Inc.
Houston, Texas, 77055, United States
Jabboury Foundation for Cancer Research, Inc.
Houston, Texas, 77082, United States
Texas Oncology, P.A.
Paris, Texas, 75460, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78217, United States
South Texas Oncology & Hematology
San Antonio, Texas, 78229, United States
Texas Oncology P.A.
Sugar Land, Texas, 77479, United States
East Texas Medical Center Cancer Institute
Tyler, Texas, 75701, United States
Texas Oncology
Tyler, Texas, 75702, United States
Texas Oncology Cancer Care and Research Center
Waco, Texas, 76712, United States
North Utah Associates
Ogden, Utah, 84403, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Southwestern Vermont Regional Cancer Center
Bennington, Vermont, 05201, United States
Rutland Regional Medical Center
Rutland, Vermont, 05701, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Cascade Cancer Center
Kirkland, Washington, 98034, United States
Cancer Care Northwest-North
Spokane, Washington, 99202, United States
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801, United States
West Virginia University Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506, United States
Wheeling Hospital
Wheeling, West Virginia, 26003, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Wheaton Franciscan Cancer Care-All Saints
Racine, Wisconsin, 53405, United States
Sydney West Cancer Trials Centre
Sydney, New South Wales, 2145, Australia
Iron Cancer Care South Brisbane
South Brisbane, Queensland, 4101, Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037, Australia
North Adelaide Oncology Calvary Hospital North Adelaide
North Adelaide, South Australia, 5006, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3050, Australia
The Western Hospital
Melbourne, Victoria, 3050, Australia
Hollywood Private Hospital
Nedlands, Western Australia, 6009, Australia
OLVZ Medische Oncologie
Aalst, 9300, Belgium
Az. St. Jan
Bruges, 8000, Belgium
Cliniques Universitaires de Bruxelles
Brussels, 1070, Belgium
VZW Jesseziekenhuis - Campus Virga Jesse
Hasselt, 3500, Belgium
Jan Yperman Ziekenhuis
Ieper, 8900, Belgium
AZ Groeninge ampus Maria's Voorzienigheid (MV) Oncologisch Centrum
Kortrijk, 8500, Belgium
Centre Hospitalier Regional de La Citadelle
Liège, 4000, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
C.H.U. Ambroise Paré
Mons, 7000, Belgium
AZ Damiaan - Site Sint-Jozef
Ostend, 8400, Belgium
AZ Zusters van Barmhartigheid
Ronse, 9600, Belgium
AZ Nikolaas
Sint-Niklaas, 9100, Belgium
Sint-Elisabethziekenhuis
Turnhout, 2300, Belgium
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD, Ist
Plovdiv, 4004, Bulgaria
District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD, Second
Plovdiv, 4004, Bulgaria
District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD
Sofia, 1233, Bulgaria
Specialised Hospital of Active Treatment in Oncology
Sofia, 1756, Bulgaria
Interdistrict Dispensary for Oncology Diseases
Varna, 9000, Bulgaria
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Jack Ady Cancer Centre
Lethbridge, Alberta, T1J 1W5, Canada
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R2H 2A6, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Stronach Regional Cancer Centre at Southlake
Newmarket, Ontario, L3Y 2P9, Canada
R.S. McLaughlin Durham Regional Cancer Centre
Oshawa, Ontario, L1G 2B9, Canada
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Humber River Regional Hospital - Church Street Site
Weston, Ontario, M9N 1N8, Canada
Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, Canada
C.H.U.M. - Hopital Notre-Dame, Departement d'Oncologie
Montreal, Quebec, H2L 4M1, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
Centre Hospitalier Affilie Universitaire de Quebec Hopital du St-Sacrement
Québec, Quebec, G1S 4L8, Canada
CSSS Alphonse-Desjardins
Québec, Quebec, G6V 3Z1, Canada
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021, China
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Beijing, 100032, China
The Hospital Affiliated Academy Military Medical Science, Chinese People's
Beijing, 100071, China
Chinese People's Liberation Army General Hospital
Beijing, 100853, China
Sun Yat-Sen University Cancer Center
Guangzhou, 510060, China
Southern Medical University Nanfang Hospital
Guangzhou, 510515, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Tianjin Cancer Hospital
Tianjin, 300060, China
Oncomedica S.A. IMAT
Montería, Departamento de Córdoba, Colombia
Oncologos del Occidente
Pereira, Risaralda Department, Colombia
Administradora Country S.A-Clinica del Country
Bogotá, Colombia
University Hospital Centre Osijek, Department of Radiotherapy and Oncology
Osijek, 31000, Croatia
General Hospital Varazdin
Varaždin, 42000, Croatia
Klinicki bolnicki centar "Sestre Milosrdnice"
Zagreb, 10000, Croatia
University Hospital Center Zagreb
Zagreb, 10000, Croatia
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Masarykuv Onkologicky ustav
Brno, 65653, Czechia
Nemocnice Jihlava
Jihlava, 58633, Czechia
Institut Onkologie a Reahabilitace na Plesi
Nová Ves pod Pleší, 26204, Czechia
Multiscan s. r. o.
Pardubice, 53003, Czechia
Fakultni Nemocnice v Motole
Prague, 15006, Czechia
Aalborg Sygehus
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus C, 8000, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Sydvestjysk Sygehus
Esbjerg, 6700, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Hillerod Hospital
Hillerød, 3400, Denmark
Næstved Sygehus
Næstved, 4700, Denmark
Odense Universitetshospital
Odense C, 5000, Denmark
Roskilde University Hospital
Roskilde, 4000, Denmark
Sygehus Sonderjylland
Sønderborg, 6400, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
Regionshospital Viborg
Viborg, 8800, Denmark
Centre Rene Gauducheau
Saint-Herblain, Cedex, 44805, France
C.H.U. De Bordeaux Saint Andre
Bordeaux, 33000, France
Centre François Baclesse
Caen, 14076, France
Centre Hospitalier de Montluçon
Clermont-Ferrand, 63011, France
Centre Georges Francois Leclerc
Dijon, 21034, France
Oncologie department, Hopital albert Michalon
Grenoble, 38043, France
Hopital de Versailles
Le Chesnay, 78157, France
Centre Oscar Lambret
Lille, 59020, France
Institut Curie, Département d'Oncologie Médicale
Paris, 75248, France
Hopital Saint Louis
Paris, 75475, France
Hopital La Pitie-Salpetriere
Paris, 75651, France
Service d'Oncologie et de Radiotherapie, Polyclinique Francheville, 38
Périgueux, 24000, France
Centre Henri Becquerel
Rouen, 76038, France
Pole Hospitalier Mutualiste
Saint-Nazaire, 44600, France
Institute de Cancerologie de la Loire
Saint-Priest-en-Jarez, 42470, France
Clinique Sainte Anne Centre de Radiothérapie
Strasbourg, 67010, France
CHU Strasbourg
Strasbourg, 67091, France
CHU Bretonneau Centre Henry Kaplan
Tours, 37044, France
Institut Gustave Roussy
Villejuif, 94800, France
CHU Paul Brousse
Villejuif, 94804, France
Marienhospital
Aachen, 52066, Germany
Onkologische Praxis
Augsburg, 86150, Germany
Sozialstiftung Bamberg Klinik fuer Haematologie und Internistische Onkologie
Bamberg, 96049, Germany
Onkologische Schwerpunktpraxis
Berlin, 10317, Germany
Praxisklinik Krebsheilkunde fuer Frauen
Berlin, 10367, Germany
Onkologische Schwerpunktpraxis
Berlin, 10707, Germany
Frauenarzt-Zentrum-Zehlendorf
Berlin, 14169, Germany
Universitaetsklinikum Duesseldorf, Frauenklinik
Düsseldorf, 40225, Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, 40225, Germany
Luisenkrankenhaus
Düsseldorf, 40235, Germany
Facharzt fuer Frauenheilkunde und Geburtshilfe
Erfurt, 99084, Germany
Onkologische Gemeinschaftspraxis Frankfurt
Frankfurt am Main, 60389, Germany
Frauenklinik der J.W. Goethe-Universitaet
Frankfurt am Main, 60590, Germany
Staedtische Kliniken Frankfurt am Main-Hoechst Frauenklinik
Frankfurt am Main, 65929, Germany
Praxis für interdisziplinaere Onkologie & Haematologie GbR
Freiburg im Breisgau, 79106, Germany
Klinikum St. Georg/Franziskus, Abteilung fuer Senologie
Georgsmarienhütte, 49124, Germany
Kreiskrankenhaus Hameln, Onkologische Ambulanz
Hamelin, 31785, Germany
Facharzt fuer Frauenheilkunde
Hanover, 30177, Germany
Onkologische Schwerpunktpraxis
Heidelberg, 69115, Germany
Nationales Centrum fuer Tumorerkrankungen
Heidelberg, 69120, Germany
Klinikum Kempten - Oberallgaeu
Kempten, 87439, Germany
MTV Abts & Partner Kiel
Kiel, 24103, Germany
Universitaetsfrauenklinikum Schleswig-Holstein
Lübeck, 23538, Germany
Universitaetsklinikum Magdeburg A.oe.R.
Magdeburg, 39108, Germany
Klinikum der Johannes-Gutenberg-Universitaet
Mainz, 55131, Germany
Fachpraxis fuer Innere Medizin
München, 80335, Germany
Klinik und Poliklinik fuer
München, 80337, Germany
Praxis Gynaekologie Arabella Muenchen
München, 81925, Germany
Klinik fuer Gynaekologie und Geburtshilfe
Offenbach, 63069, Germany
Pius-Hospital Oldenburg
Oldenburg, 26121, Germany
Klinikum Oldenburg GmbH
Oldenburg, 26133, Germany
Oncologianova GmbH
Recklinghausen, 45657, Germany
Universitaetsfrauenklinik Tuebingen
Tübingen, 72076, Germany
St. Marienhospital Vechta
Vechta, 49377, Germany
Gemeinschaftspraxis fuer Haematologie und Onkologie
Westerstede, 26655, Germany
Klinik für Gynaekologie und gyn. Onkologie
Wiesbaden, 65199, Germany
Marienhospital Witten
Witten, 58452, Germany
University Hospital of Heraklion
Heraklion, Creete, 71110, Greece
General Hospital of Chania Ag. Georgios
Chania, Crete, 73300, Greece
University General Hospital of Alexandroupoli, Department of Medical Oncology
Alexandroupoli, 68100, Greece
Hippokratio General Hospital of Athens
Athens, 11527, Greece
Hippokration Hospital Athens
Athens, 11527, Greece
University General Hospital of Larissa
Larissa, 41110, Greece
University Hospital of Patras
Rio Patras, 26500, Greece
Euromedica General Clinic
Thessaloniki, 54645, Greece
UNIMED Medical Institute, Comprehensive Centre for Breast Diseases
Hong Kong, Wan Chai, 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, Blk K
Hong Kong, Hong Kong
Queen Mary Hospital, Department of Medicine
Hong Kong, Hong Kong
Semmelweis Egyetem Radiologiai és Onkoterapias Klinika
Budapest, 1082, Hungary
Fovarosi Onkormanyzat Szent Imre Korhaz
Budapest, 1115, Hungary
Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly
Budapest, 1122, Hungary
Bekes M. Kepviselotest. Pandy Kalman Korhaz, Megyei Onkol. Kp., Klin. Onkol. es Sugartherapias Oszt.
Gyula, 5700, Hungary
Kaposi Mor Oktato Korhaz, Onkologiai Centrum
Kaposvár, 7400, Hungary
Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont
Kecskemét, 6000, Hungary
Borsod-Abauj-Zemplen M. Korhaz es Egyetemi Okt. K., Klin. Onk., Sugarterapias es Kozp. Szuro Centrum
Miskolc, 3526, Hungary
Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft. / Onkoradiologiai Osztaly
Nyíregyháza, 4400, Hungary
Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.
Veszprém, 8200, Hungary
Soroka University MC, Department of Oncology
Beersheba, 84101, Israel
Rambam Health care campus, Oncology institute
Haifa, 31096, Israel
Kaplan Medical Center, Department of Oncology
Rehovot, 76100, Israel
Sheba Medical Center, Oncology Institute Tel Hashomer
Tel Litwinsky, 52621, Israel
Azienda Ospedaliera San Giuseppe Moscati
Avellino, 83100, Italy
Presidio Ospedaliero di Summa - Antonio Perrino
Brindisi, 72100, Italy
Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele"
Catania, 95123, Italy
Fondazione per la Ricerca e la Cura dei Tumori Tommaso Campanella
Catanzaro, 88100, Italy
Azienda Ospedaliera San Gerardo
Monza, 20052, Italy
Fondazione Giovanni Pascale
Napoli, 80131, Italy
Unita' Operativa Complessa Oncologia Medica, A.O.R.N. "Cardarelli"
Napoli, 80131, Italy
Azienda Ospedaliera San Luigi Gonzaga
Orbassano (TO), 10043, Italy
IRCCS Istituto Oncologico Veneto di Padova
Padua, 35131, Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, 56126, Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Calabria, 89124, Italy
Universita Campus Bio-Medico
Roma, 00128, Italy
Oncologia Medica A, Istituti Fisioterapici Ospitalieri
Roma, 00144, Italy
Ospedale San Pietro Fatebenefratelli
Roma, 00189, Italy
Ospedale SS Trinita
Sora (FR), 03039, Italy
Azienda Ospedaliera S. Maria
Terni, 05100, Italy
Ospedale Treviglio e Caravaggio, UO Oncologia Medica
Treviglio, BG, 24047, Italy
Istituto Oncologico del Mediterraneo
Viagrande (CT), 95029, Italy
Ospedale Belcolle Viterbo
Viterbo, 01100, Italy
Aichi Cancer Center
Aichi, 464-8681, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
National Cancer Center Hospital East
Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Ehime, 791-0280, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Kurume Daiichi Social Insurance Hospital
Fukuoka, 830-0013, Japan
Hiroshima City Hospital
Hiroshima, 730-8518, Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido, 003-0804, Japan
Hyogo Cancer Center
Hyōgo, 673-8558, Japan
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima, 892-0833, Japan
Kanagawa Cancer Center
Kanagawa, 241-0815, Japan
Tokai University Hospital
Kanagawa, 259-1193, Japan
Kumamoto Municipal Hospital
Kumamoto, 862-8505, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Niigata Cancer Center Hospital 2-15-3
Niigata, 951-8566, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, 537-8511, Japan
National Hospital Organization Osaka National Hospital
Osaka, 540-0006, Japan
Osaka University Hospital
Osaka, 565-0871, Japan
Saitama Cancer Center
Saitama, 362-0806, Japan
Shizuoka Cancer Center
Shizuoka, 411-8777, Japan
Jichi Medical University Hospital
Tochigi, 329-0498, Japan
Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hp
Tokyo, 113-8677, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo, 135-8550, Japan
The Hospital of Lithuanian University of Health Sciences Kauno klinikos Oncology and Haematology Clinic
Kaunas, LT-50161, Lithuania
Oncology Institute of Vilnius University
Vilnius, LT-08661, Lithuania
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Sir Paul Boffa Hospital
Floriana, VLT 14, Malta
Nucleo de Especialidades Oncológicas
Guadalajara, Jalisco, 44670, Mexico
Ziekenhuis Amstelland
Amstelveen, 1186 AM, Netherlands
Gelre ZH
Apeldoorn, 7334 DZ, Netherlands
Amphia Ziekenhuis - Interne Geneeskunde
Breda, 4819 EV, Netherlands
Maxima Medisch Centrum
Eindhoven, 5631 BM, Netherlands
Vlietland Ziekenhuis
Schiedam, 3118 JH, Netherlands
Orbis Medisch Centrum
Sittard-Geleen, 6162 BG, Netherlands
Haga Ziekenhuis
The Hague, 2545 CH, Netherlands
Auckland Hospital
Auckland, 1023, New Zealand
University Clinic for Radiotherapy and Oncology
Skopje, 1000, North Macedonia
Clínica Vista Alegre / Unidad de Investigacion
Surco, Lima region, 33, Peru
Bialostockie Centrum Onkologii im. M. Sklodowskiej- Curie w Bialymstoku
Bialystok, 15027, Poland
Centrum Onkologii im. prof. Franciszka Łukaszczyka
Bydgoszcz, 85-796, Poland
Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"
Bydgoszcz, 85796, Poland
Uniwersyteckie Centrum Kliniczne w Gdansku
Gdansk, 80952, Poland
Szpital Morski im. PCK Gdynskie Centrum Onkologii Oddzial Chemioterapii
Gdynia, 81519, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial
Jelenia Góra, 58506, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w
Krakow, 31531, Poland
Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w
Olsztyn, 10228, Poland
Olsztynski Osrodek Onkologiczny Kopernik Sp. z o.o.
Olsztyn, 10513, Poland
Szpital Wojewodzki im. Sw. Lukasza Samodzielny Publiczny Zaklad Opieki
Tarnów, 33100, Poland
Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"
Warsaw, 04125, Poland
Institutul Oncologic "Prof. Dr. Ion Chiricuta"
Cluj-Napoca, Cluj, 400015, Romania
SC Oncolab S.R.L.
Craiova, Dolj, 200385, Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098, Romania
Institute of Oncology and Radiology of Serbia
Belgrade, 11000, Serbia
Clinical centre Nis
Niš, 18000, Serbia
National Cancer Centre Singapore
Singapore, 169610, Singapore
Interna onkologicka klinika
Bratislava, 81250, Slovakia
Oddelenie radioterapie a onkologie
Košice, 04191, Slovakia
Poliklinika ADUS
Poprad, 05801, Slovakia
Samsung Medical Center
Seoul, Korea, 135-710, South Korea
National Cancer Center, Center for Breast Cancer
Gyeonggi-do, 410-769, South Korea
Seoul National University Hospital, Department of Internal Medicine
Seoul, 110-744, South Korea
Korea University Anam Hospital, Department of Oncology/Hematology
Seoul, 136-705, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
Hospital de Torrevieja
Torrevieja, Alicante, 03186, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, 07010, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
ICO de Barcelona - Hospital Duran i Reynals, Hospitalet de Llobregat Consorci Sanitari de Terrassa
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Mutua de Terrassa
Terrassa, Barcelona, 08221, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227, Spain
Consorcio Hospitalario Provincial de Castellon
Castellon, Castellon, 12002, Spain
Hospital de Barbastro
Barbastro, Huesca, 22300, Spain
Hospital Universitario Fundacion de Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital Puerta de Hierro-Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
Hospital De Basurto
Bilbao, Vizcaya, 48013, Spain
Centro Oncologico de Galicia
A Coruña, 15009, Spain
Hospital Universitario Vall D´Hebron
Barcelona, 08035, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Puerta del Mar
Cadiz, 11009, Spain
Hospital San Pedro de Alcantara
Cáceres, 10003, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
ICO de Girona - Hospital Universitario de Girona Dr. Josep Trueta
Girona, 17007, Spain
Hospital Universitario de Guadalajara
Guadalajara, 19002, Spain
Complejo Hospitalario de Jaen
Jaén, 23007, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, 35016, Spain
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, 25198, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Madrid Norte Sanchinarro. Centro Integral Oncologico Clara Campal
Madrid, 28050, Spain
Hospital Clinico Universitario Virgen de La Victoria
Málaga, 14004, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Virgen de la Salud
Toledo, 45004, Spain
Fundacion Instituto Valenciano de Oncologia
Valencia, 46010, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Provincial de Zamora
Zamora, 49021, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Onkologiska Kliniken
Lund, 22185, Sweden
Skanes Onkologiska Kliniken
Lund, 22185, Sweden
Hirslanden Medical Center Tumor Center
Aarau, 5000, Switzerland
Kantonsspital Baden
Baden, 5404, Switzerland
Kantonsspital Olten-Medizinische Onkologie
Olten, 4600, Switzerland
Spital STS AG
Thun, 3600, Switzerland
Kaohsiung Medical University Chung-Ho memorial Hospital
Kaohsiung City, 807, Taiwan
Chang Gung Medical Foundation, Linkou Branch
Kwei-Shan, Taoyuan, 333, Taiwan
National Taiwan University Hospital
Taipei TOC, 100, Taiwan
Affinity Research Limited
Nassau, 13932, The Bahamas
Gazi Universitesi Tip Fakultesi
Besevler/Ankara, 06500, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Bornova/Izmir, 35100, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Capa/Istanbul, 34390, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi, Ic Hastaliklari Anabilim Dali
Cerrahpasa/Istanbul, 34098, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi
Demetevler/Ankara, 06200, Turkey (Türkiye)
Uludag Universitesi Tip Fakultesi
Gorukle/Bursa, 16059, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Inciralti/Izmir, 35340, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul, 34890, Turkey (Türkiye)
Gaziantep Universitesi
Sehitkamil/Gaziantep, 27310, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Sihhiye/Ankara, 06100, Turkey (Türkiye)
Betsi Cadwaladr University Health Board
Rhyl, Denbighshire, LL18 5UJ, United Kingdom
Queens Hospital
Burton-on-Trent, Staffs, DE13 0RB, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
University Hospitals of Leicester
Leicester, LE1 5WW, United Kingdom
St. Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
Charing Cross Hospital, Department Of Medical Oncology
London, W6 8RF, United Kingdom
Christie Hospital
Manchester, M20 4BX, United Kingdom
Norfolk & Norwich University Hospitals
Norwich, NR4 7UY, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Weston Park Hospital
Sheffield, S10 2SJ, United Kingdom
Singleton Hospital
Swansea, SA2-8QA, United Kingdom
Southend University Hospital
Westcliff-on-Sea, SS0 0RY, United Kingdom
Related Publications (7)
Holmes FA, Moy B, Delaloge S, Chia SKL, Ejlertsen B, Mansi J, Iwata H, Gnant M, Buyse M, Barrios CH, Silovski T, Separovic R, Bashford A, Zotano AG, Denduluri N, Patt D, Gokmen E, Gore I, Smith JW 2nd, Loibl S, Masuda N, Tomasevic Z, Petrakova K, DiPrimeo D, Wong A, Martin M, Chan A; ExteNET Study Group. Overall survival with neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): A randomised, double-blind, placebo-controlled, phase 3 trial. Eur J Cancer. 2023 May;184:48-59. doi: 10.1016/j.ejca.2023.02.002. Epub 2023 Feb 10.
PMID: 36898233DERIVEDIwata H, Masuda N, Kim SB, Inoue K, Rai Y, Fujita T, Chiu J, Ohtani S, Takahashi M, Miyaki T, Lu YS, Xu B, Yap YS, Bustam A, Yao B, Zhang B, Bryce R, Chan A. Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer. Future Oncol. 2019 Jul;15(21):2489-2501. doi: 10.2217/fon-2019-0143. Epub 2019 May 29.
PMID: 31140297DERIVEDChia SKL, Martin M, Holmes FA, Ejlertsen B, Delaloge S, Moy B, Iwata H, von Minckwitz G, Mansi J, Barrios CH, Gnant M, Tomasevic Z, Denduluri N, Separovic R, Kim SB, Jakobsen EH, Harvey V, Robert N, Smith J 2nd, Harker G, Zhang B, Eli LD, Ye Y, Lalani AS, Buyse M, Chan A. PIK3CA alterations and benefit with neratinib: analysis from the randomized, double-blind, placebo-controlled, phase III ExteNET trial. Breast Cancer Res. 2019 Mar 11;21(1):39. doi: 10.1186/s13058-019-1115-2.
PMID: 30867034DERIVEDMortimer J, Di Palma J, Schmid K, Ye Y, Jahanzeb M. Patterns of occurrence and implications of neratinib-associated diarrhea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial. Breast Cancer Res. 2019 Feb 27;21(1):32. doi: 10.1186/s13058-019-1112-5.
PMID: 30813966DERIVEDDelaloge S, Cella D, Ye Y, Buyse M, Chan A, Barrios CH, Holmes FA, Mansi J, Iwata H, Ejlertsen B, Moy B, Chia SKL, Gnant M, Smichkoska S, Ciceniene A, Martinez N, Filipovic S, Ben-Baruch NE, Joy AA, Langkjer ST, Senecal F, de Boer RH, Moran S, Yao B, Bryce R, Auerbach A, Fallowfield L, Martin M. Effects of neratinib on health-related quality of life in women with HER2-positive early-stage breast cancer: longitudinal analyses from the randomized phase III ExteNET trial. Ann Oncol. 2019 Apr 1;30(4):567-574. doi: 10.1093/annonc/mdz016.
PMID: 30689703DERIVEDMartin M, Holmes FA, Ejlertsen B, Delaloge S, Moy B, Iwata H, von Minckwitz G, Chia SKL, Mansi J, Barrios CH, Gnant M, Tomasevic Z, Denduluri N, Separovic R, Gokmen E, Bashford A, Ruiz Borrego M, Kim SB, Jakobsen EH, Ciceniene A, Inoue K, Overkamp F, Heijns JB, Armstrong AC, Link JS, Joy AA, Bryce R, Wong A, Moran S, Yao B, Xu F, Auerbach A, Buyse M, Chan A; ExteNET Study Group. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1688-1700. doi: 10.1016/S1470-2045(17)30717-9. Epub 2017 Nov 13.
PMID: 29146401DERIVEDChan A, Delaloge S, Holmes FA, Moy B, Iwata H, Harvey VJ, Robert NJ, Silovski T, Gokmen E, von Minckwitz G, Ejlertsen B, Chia SKL, Mansi J, Barrios CH, Gnant M, Buyse M, Gore I, Smith J 2nd, Harker G, Masuda N, Petrakova K, Zotano AG, Iannotti N, Rodriguez G, Tassone P, Wong A, Bryce R, Ye Y, Yao B, Martin M; ExteNET Study Group. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):367-377. doi: 10.1016/S1470-2045(15)00551-3. Epub 2016 Feb 10.
PMID: 26874901DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Clinical Operations
- Organization
- Puma Biotechnology, Inc.
Study Officials
- STUDY DIRECTOR
Senior Vice President Clinical Science and Pharmacology
Puma Biotechnology, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2009
First Posted
April 9, 2009
Study Start
July 9, 2009
Primary Completion
August 21, 2014
Study Completion
October 4, 2019
Last Updated
June 11, 2021
Results First Posted
October 9, 2017
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
- Access Criteria
- Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest. Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge. In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings. Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information. Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.