AzTrials
AzTrials

Breast CancerPhase 3ExteNETNCT00878709

Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

A Phase 3 study testing neratinib in people with Breast Cancer, run by Puma Biotechnology, Inc. at 494 sites in 40 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
neratinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,840 participants
Where
494 sitesin 40 countries
Study dates
9 Jul 2009to 4 Oct 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

494 sites in 40 countries.

494 sites in 40 countries

United States185 sites

  • Phoebe Cancer Center

    Albany, Georgia, 31701

  • Anniston Oncology

    Anniston, Alabama, 36207

  • Ashland-Bellefonte Cancer Center

    Ashland, Kentucky, 41101-7016

  • Piedmont Cancer Institute

    Atlanta, Georgia, 30318

  • Augusta Oncology Associates (ACORN), P.C.

    Augusta, Georgia, 30909

  • Texas Oncology, P.A.

    Austin, Texas, 78731

  • Innovative Medical Research of South Florida, Inc.

    Aventura, Florida, 33180

  • Medical Oncology & Hematology Mercy Medical Center

    Baltimore, Maryland, 21202

  • Harry and Jeanette Weinberg Cancer Center

    Baltimore, Maryland, 21237

  • Hematology-Oncology Clinic

    Baton Rouge, Louisiana, 70809

  • Texas Oncology, P.A.

    Bedford, Texas, 76022

  • Bend Memorial Clinic

    Bend, Oregon, 97701

  • Southwestern Vermont Regional Cancer Center

    Bennington, Vermont, 05201

  • Oncology-Hematology of Lehigh Valley, PC

    Bethlehem, Pennsylvania, 18015

  • Cedars-Sinai Medical Group

    Beverly Hills, California, 90211

  • Birmingham Hematology and Oncology Associates, LLC

    Birmingham, Alabama, 35205

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Massachusetts General Hospital - Gillette Center

    Boston, Massachusetts, 02215

  • University Cancer Institute, LLC

    Boynton Beach, Florida, 33426

  • Charleston Hematology Oncology Associates, PA

    Charleston, South Carolina, 29414

  • Medical University of South Carolina Hollings Cancer Center

    Charleston, South Carolina, 29425

  • University Hematology/Oncology Associates PLLC

    Chattanooga, Tennessee, 37403

  • The Center for Cancer and Hematologic Disease

    Cherry Hill, New Jersey, 08003

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University Hospitals, Cleveland Medical Center

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Francisco Gonzalez MD PA

    Columbia, South Carolina, 29203

  • NorthEast Oncology Associates Carolinas Medical Center NorthEast

    Concord, North Carolina, 28025

  • Cookeville Regional Cancer Center

    Cookeville, Tennessee, 38501

  • Coastal Bend Cancer Center

    Corpus Christi, Texas, 78404

  • South Texas Institute of Cancer

    Corpus Christi, Texas, 78405

  • Cancer Specialists of South Texas, P.A.

    Corpus Christi, Texas, 78412

  • Samaritan Hematology & Oncology Consultants

    Corvallis, Oregon, 97330

  • Center for Oncology Research

    Dallas, Texas, 75230

  • Texas Oncology, P.A.

    Dallas, Texas, 75231-4400

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center Simmons Cancer Center

    Dallas, Texas, 75390

  • Cancer Care Specialists of Illinois, Decatur Memorial Hospital Clinical Research

    Decatur, Illinois, 62526

  • North Broward Medical Center

    Deerfield Beach, Florida, 33064

  • Texas Oncology, P.A.

    Denton, Texas, 76210

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-2013

  • Duke University Medical Center Medical Oncology

    Durham, North Carolina, 27710

  • El Paso Cancer Treatment Center - West

    El Paso, Texas, 79902

  • Center for Integrative Cancer Medicine, PA

    El Paso, Texas, 79912

  • Trinitas Comprehensive Cancer Center

    Elizabeth, New Jersey, 07207

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • McLeod Oncology and Hematology Associates

    Florence, South Carolina, 29506

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905-5650

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Texas Oncology

    Fort Worth, Texas, 76104

  • Florida Cancer Specialists and Research Institute

    Gainesville, Florida, 32605

  • Texas Oncology, P.A.

    Garland, Texas, 75042

  • The Jones Clinic, PC

    Germantown, Tennessee, 38138

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Ronald Yanagihara, M.D.

    Gilroy, California, 95020

  • Glendale Adventist Medical Center Cancer Services

    Glendale, California, 91206

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

  • Medical Specialty Associates

    Grand Rapids, Michigan, 49503

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • California Cancer Care

    Greenbrae, California, 94904

  • Pinnacle Health Cancer Center Community Campus

    Harrisburg, Pennsylvania, 17109

  • Beaver Medical Group, L.P.

    Highland, California, 92346

  • South Carolina Cancer Specialists

    Hilton Head Island, South Carolina, 29926

  • Straub Clinic & Hospital

    Honolulu, Hawaii, 96813-3083

  • Texas Oncology - Memorial City

    Houston, Texas, 77024

  • The Methodist Hospital Breast Center

    Houston, Texas, 77030

  • Medicus Alliance Clinical Research Org., Inc.

    Houston, Texas, 77055

  • Jabboury Foundation for Cancer Research, Inc.

    Houston, Texas, 77082

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46219

  • Hematology Oncology of Indiana

    Indianapolis, Indiana, 46260-2082

  • Capitol Comprehensive Cancer Care Clinic

    Jefferson City, Missouri, 65109

  • Midwest Center for Hematology/Oncology

    Joliet, Illinois, 60432

  • Northeast Arkansas Clinic

    Jonesboro, Arkansas, 72401

  • Cascade Cancer Center

    Kirkland, Washington, 98034

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • ProHealth Care Associates

    Lake Success, New York, 11042

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Central Maine Healthcare Corp

    Lewiston, Maine, 04240

  • Southeast Nebraska Hematology & Oncology Consultants, PC

    Lincoln, Nebraska, 68510

  • Saint Barnabas Health Care System

    Livingston, New Jersey, 07039

  • Breastlink Medical Group

    Long Beach, California, 90806

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Hematology Oncology Associates

    Loxahatchee Groves, Florida, 33470

  • Crescent City Research Consortium, LLC

    Marrero, Louisiana, 70072

  • Signal Point Hematology/Oncology, Inc.

    Middletown, Ohio, 45042

  • Minnesota Oncology Hematology, PA

    Minneapolis, Minnesota, 55404

  • Facey Medical Group

    Mission Hills, California, 91345

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Medical Arts Associates, Ltd

    Moline, Illinois, 61265

  • Sweeney-Melenyser Pavillion

    Monongahela, Pennsylvania, 15063

  • West Virginia University Mary Babb Randolph Cancer Center

    Morgantown, West Virginia, 26506

  • Summit Medical Group

    Morristown, New Jersey, 07960

  • Oncology and Hematology Specialist

    Mountain Lakes, New Jersey, 07046

  • Community Hospital

    Munster, Indiana, 46321

  • Nashville Breast Center

    Nashville, Tennessee, 37203

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07754

  • NYU Clinical Cancer Center

    New York, New York, 10016

  • Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Gynecologic Oncology Associates

    Newport Beach, California, 92663

  • Advocate Medical Group

    Niles, Illinois, 60714

  • Cancer Care & Hematology Specialists of Chicagoland

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Great Plains Regional Medical Center

    North Platte, Nebraska, 69101

  • Florida Cancer Affiliates - Ocala

    Ocala, Florida, 34471

  • North Utah Associates

    Ogden, Utah, 84403

  • Mercy Physicians of Oklahoma

    Oklahoma City, Oklahoma, 73120

  • Mid-Florida Hematology & Oncology Centers, PA

    Orange City, Florida, 32763-8316

  • Cancer Centers of Florida

    Orlando, Florida, 32806

  • M.D. Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Ventura County Hematology-Oncology Specialists

    Oxnard, California, 93030

  • Purchase Cancer Group

    Paducah, Kentucky, 42001

  • The Valley Hospital, Luckow Pavilion

    Paramus, New Jersey, 07652

  • Texas Oncology, P.A.

    Paris, Texas, 75460

  • Pawtuket Memorial Hospital

    Pawtucket, Rhode Island, 02860

  • Northern Michigan Hematology/Oncology

    Petoskey, Michigan, 49770

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • Arizona Oncology Associates, PC - HAL

    Phoenix, Arizona, 85016

  • Florida Cancer Research Institute

    Plantation, Florida, 33324

  • Portneuf Medical Center

    Pocatello, Idaho, 83201

  • Hematology Oncology Associates of Treasure Coast

    Port Saint Lucie, Florida, 34592

  • Mercy Hospital Oncology/Hematology Center

    Portland, Maine, 04102

  • Northwest Cancer Specialist, P.C.

    Portland, Oregon, 97213

  • Providence Cancer Center Oncology and Hematology Care - Westside

    Portland, Oregon, 97213

  • Kaiser Permanente Northwest Region Oncology Hematology

    Portland, Oregon, 97227-1110

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Quincy Medical Group, Cancer Center at Blessing Hospital

    Quincy, Illinois, 62301

  • Wheaton Franciscan Cancer Care-All Saints

    Racine, Wisconsin, 53405

  • Raleigh Hematology Oncology Associates Cancer Centers of North Carolina

    Raleigh, North Carolina, 27607

  • Desert Hematology Oncology Medical Group, Inc

    Rancho Mirage, California, 92270

  • Rutland Regional Medical Center

    Rutland, Vermont, 05701

  • St. Joseph's Oncology

    Saint Joseph, Missouri, 64507

  • Park Nicollet Institute

    Saint Louis Park, Minnesota, 55426

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78217

  • South Texas Oncology & Hematology

    San Antonio, Texas, 78229

  • Helen Diller Family University of California San Francisco Comprehensive Cancer Center

    San Francisco, California, 94115

  • San Francisco Oncology Associates

    San Francisco, California, 94115

  • Redwood Regional Medical Group

    Santa Rosa, California, 95403

  • Guthrie Clinic, Limited

    Sayre, Pennsylvania, 18840

  • Arizona Oncology Associates, PC - NAHOA

    Sedona, Arizona, 86336

  • Avera Medical Oncology and Hematology - Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • North Shore Cancer Research Associates

    Skokie, Illinois, 60076

  • Orchard Healthcare Research, Inc.

    Skokie, Illinois, 60076

  • Orchard Research, LLC

    Skokie, Illinois, 60076

  • The Cancer Prevention and Treatment Center

    Soquel, California, 95073

  • Cancer Center of Central Connecticut

    Southington, Connecticut, 06489

  • Cancer Care Northwest-North

    Spokane, Washington, 99202

  • Simmons Cancer Institute

    Springfield, Illinois, 62702

  • Springfield Clinic, LLP

    Springfield, Illinois, 62702

  • Mercy Medical Research Institute

    Springfield, Missouri, 65807

  • Willamette Valley Cancer Institute and Research Center

    Springfield, Oregon, 97477

  • Washington University School of Medicine Siteman Cancer Center

    St Louis, Missouri, 63110

  • Florida Cancer Specialists, P.L.

    St. Petersburg, Florida, 33705

  • Hematology Oncology, PC

    Stamford, Connecticut, 06902

  • Texas Oncology P.A.

    Sugar Land, Texas, 77479

  • Santee Hematology Oncology

    Sumter, South Carolina, 29150

  • Northwest Medical Specialties PLLC

    Tacoma, Washington, 98405

  • Oncology and Hematology of West Broward

    Tamarac, Florida, 33321

  • Eastchester Center for Cancer Care

    The Bronx, New York, 10469

  • Connecticut Oncology and Hematology

    Torrington, Connecticut, 06790

  • Arizona Oncology Associates

    Tucson, Arizona, 85704-7891

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • North Mississippi Hematology and Oncology Associates, Ltd.

    Tupelo, Mississippi, 38801

  • East Texas Medical Center Cancer Institute

    Tyler, Texas, 75701

  • Texas Oncology

    Tyler, Texas, 75702

  • Cooper University Hospital

    Voorhees Township, New Jersey, 08043-4689

  • Texas Oncology Cancer Care and Research Center

    Waco, Texas, 76712

  • Washington Cancer Institute at Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • Alliance Hematology Oncology, PA Carroll County Cancer Center

    Westminster, Maryland, 21157

  • Wheeling Hospital

    Wheeling, West Virginia, 26003

  • Abington Hematology Oncology Associates, Inc

    Willow Grove, Pennsylvania, 19090-1137

  • Hanover Medical Specialists, PA

    Wilmington, North Carolina, 28401

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

  • York Hospital Oncology Treatment Center

    York Village, Maine, 03909

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida, 33542

  • Midwestern Regional Medical Center

    Zion, Illinois, 60099

Other trials in United States

Germany37 sites

  • Marienhospital

    Aachen, 52066

  • Onkologische Praxis

    Augsburg, 86150

  • Sozialstiftung Bamberg Klinik fuer Haematologie und Internistische Onkologie

    Bamberg, 96049

  • Onkologische Schwerpunktpraxis

    Berlin, 10317

  • Praxisklinik Krebsheilkunde fuer Frauen

    Berlin, 10367

  • Onkologische Schwerpunktpraxis

    Berlin, 10707

  • Frauenarzt-Zentrum-Zehlendorf

    Berlin, 14169

  • Universitaetsklinikum Duesseldorf, Frauenklinik

    Düsseldorf, 40225

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

  • Luisenkrankenhaus

    Düsseldorf, 40235

  • Facharzt fuer Frauenheilkunde und Geburtshilfe

    Erfurt, 99084

  • Onkologische Gemeinschaftspraxis Frankfurt

    Frankfurt am Main, 60389

  • Frauenklinik der J.W. Goethe-Universitaet

    Frankfurt am Main, 60590

  • Staedtische Kliniken Frankfurt am Main-Hoechst Frauenklinik

    Frankfurt am Main, 65929

  • Praxis für interdisziplinaere Onkologie & Haematologie GbR

    Freiburg im Breisgau, 79106

  • Klinikum St. Georg/Franziskus, Abteilung fuer Senologie

    Georgsmarienhütte, 49124

  • Kreiskrankenhaus Hameln, Onkologische Ambulanz

    Hamelin, 31785

  • Facharzt fuer Frauenheilkunde

    Hanover, 30177

  • Onkologische Schwerpunktpraxis

    Heidelberg, 69115

  • Nationales Centrum fuer Tumorerkrankungen

    Heidelberg, 69120

  • Klinikum Kempten - Oberallgaeu

    Kempten, 87439

  • MTV Abts & Partner Kiel

    Kiel, 24103

  • Universitaetsfrauenklinikum Schleswig-Holstein

    Lübeck, 23538

  • Universitaetsklinikum Magdeburg A.oe.R.

    Magdeburg, 39108

  • Klinikum der Johannes-Gutenberg-Universitaet

    Mainz, 55131

  • Fachpraxis fuer Innere Medizin

    München, 80335

  • Klinik und Poliklinik fuer

    München, 80337

  • Praxis Gynaekologie Arabella Muenchen

    München, 81925

  • Klinik fuer Gynaekologie und Geburtshilfe

    Offenbach, 63069

  • Pius-Hospital Oldenburg

    Oldenburg, 26121

  • Klinikum Oldenburg GmbH

    Oldenburg, 26133

  • Oncologianova GmbH

    Recklinghausen, 45657

  • Universitaetsfrauenklinik Tuebingen

    Tübingen, 72076

  • St. Marienhospital Vechta

    Vechta, 49377

  • Gemeinschaftspraxis fuer Haematologie und Onkologie

    Westerstede, 26655

  • Klinik für Gynaekologie und gyn. Onkologie

    Wiesbaden, 65199

  • Marienhospital Witten

    Witten, 58452

Other trials in Germany

Spain36 sites

  • Centro Oncologico de Galicia

    A Coruña, 15009

  • Hospital Universitario Fundacion de Alcorcon

    Alcorcón, Madrid, 28922

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital de Barbastro

    Barbastro, Huesca, 22300

  • Hospital Universitario Vall D´Hebron

    Barcelona, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital De Basurto

    Bilbao, Vizcaya, 48013

  • Hospital San Pedro de Alcantara

    Cáceres, 10003

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

  • Consorcio Hospitalario Provincial de Castellon

    Castellon, Castellon, 12002

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • ICO de Girona - Hospital Universitario de Girona Dr. Josep Trueta

    Girona, 17007

  • Hospital Universitario de Guadalajara

    Guadalajara, 19002

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • ICO de Barcelona - Hospital Duran i Reynals, Hospitalet de Llobregat Consorci Sanitari de Terrassa

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, 35016

  • Hospital Universitari Arnau de Vilanova de Lleida

    Lleida, 25198

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Madrid Norte Sanchinarro. Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Puerta de Hierro-Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Clinico Universitario Virgen de La Victoria

    Málaga, 14004

  • Hospital Universitari Son Espases

    Palma de Mallorca, Balearic Islands, 07010

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, 38010

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona, 08227

  • Hospital Virgen de la Salud

    Toledo, 45004

  • Hospital de Torrevieja

    Torrevieja, Alicante, 03186

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, 46010

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Provincial de Zamora

    Zamora, 49021

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Japan23 sites

  • Aichi Cancer Center

    Aichi, 464-8681

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • National Hospital Organization Shikoku Cancer Center

    Ehime, 791-0280

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Kurume Daiichi Social Insurance Hospital

    Fukuoka, 830-0013

  • Hiroshima City Hospital

    Hiroshima, 730-8518

  • National Hospital Organization Hokkaido Cancer Center

    Hokkaido, 003-0804

  • Hyogo Cancer Center

    Hyōgo, 673-8558

  • Hakuaikai Medical Corporation Sagara Hospital

    Kagoshima, 892-0833

  • Kanagawa Cancer Center

    Kanagawa, 241-0815

  • Tokai University Hospital

    Kanagawa, 259-1193

  • Kumamoto Municipal Hospital

    Kumamoto, 862-8505

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Niigata Cancer Center Hospital 2-15-3

    Niigata, 951-8566

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka, 537-8511

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • Osaka University Hospital

    Osaka, 565-0871

  • Saitama Cancer Center

    Saitama, 362-0806

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • Jichi Medical University Hospital

    Tochigi, 329-0498

  • Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hp

    Tokyo, 113-8677

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Tokyo, 135-8550

Other trials in Japan

France20 sites

  • C.H.U. De Bordeaux Saint Andre

    Bordeaux, 33000

  • Centre François Baclesse

    Caen, 14076

  • Centre Hospitalier de Montluçon

    Clermont-Ferrand, 63011

  • Centre Georges Francois Leclerc

    Dijon, 21034

  • Oncologie department, Hopital albert Michalon

    Grenoble, 38043

  • Hopital de Versailles

    Le Chesnay, 78157

  • Centre Oscar Lambret

    Lille, 59020

  • Institut Curie, Département d'Oncologie Médicale

    Paris, 75248

  • Hopital Saint Louis

    Paris, 75475

  • Hopital La Pitie-Salpetriere

    Paris, 75651

  • Service d'Oncologie et de Radiotherapie, Polyclinique Francheville, 38

    Périgueux, 24000

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Rene Gauducheau

    Saint-Herblain, Cedex, 44805

  • Pole Hospitalier Mutualiste

    Saint-Nazaire, 44600

  • Institute de Cancerologie de la Loire

    Saint-Priest-en-Jarez, 42470

  • Clinique Sainte Anne Centre de Radiothérapie

    Strasbourg, 67010

  • CHU Strasbourg

    Strasbourg, 67091

  • CHU Bretonneau Centre Henry Kaplan

    Tours, 37044

  • Institut Gustave Roussy

    Villejuif, 94800

  • CHU Paul Brousse

    Villejuif, 94804

Other trials in France

Italy19 sites

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, 83100

  • Presidio Ospedaliero di Summa - Antonio Perrino

    Brindisi, 72100

  • Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele"

    Catania, 95123

  • Fondazione per la Ricerca e la Cura dei Tumori Tommaso Campanella

    Catanzaro, 88100

  • Azienda Ospedaliera San Gerardo

    Monza, 20052

  • Fondazione Giovanni Pascale

    Naples, 80131

  • Unita' Operativa Complessa Oncologia Medica, A.O.R.N. "Cardarelli"

    Naples, 80131

  • Azienda Ospedaliera San Luigi Gonzaga

    Orbassano (TO), 10043

  • IRCCS Istituto Oncologico Veneto di Padova

    Padova, 35131

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126

  • Azienda Ospedaliera Bianchi Melacrino Morelli

    Reggio Calabria, 89124

  • Universita Campus Bio-Medico

    Roma, 00128

  • Oncologia Medica A, Istituti Fisioterapici Ospitalieri

    Roma, 00144

  • Ospedale San Pietro Fatebenefratelli

    Roma, 00189

  • Ospedale SS Trinita

    Sora (FR), 03039

  • Azienda Ospedaliera S. Maria

    Terni, 05100

  • Ospedale Treviglio e Caravaggio, UO Oncologia Medica

    Treviglio, BG, 24047

  • Istituto Oncologico del Mediterraneo

    Viagrande (CT), 95029

  • Ospedale Belcolle Viterbo

    Viterbo, 01100

Other trials in Italy

Canada14 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Jack Ady Cancer Centre

    Lethbridge, Alberta, T1J 1W5

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

  • C.H.U.M. - Hopital Notre-Dame, Departement d'Oncologie

    Montreal, Quebec, H2L 4M1

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Stronach Regional Cancer Centre at Southlake

    Newmarket, Ontario, L3Y 2P9

  • R.S. McLaughlin Durham Regional Cancer Centre

    Oshawa, Ontario, L1G 2B9

  • Centre Hospitalier Affilie Universitaire de Quebec Hopital du St-Sacrement

    Québec, Quebec, G1S 4L8

  • CSSS Alphonse-Desjardins

    Québec, Quebec, G6V 3Z1

  • University Health Network, Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BC Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

  • Humber River Regional Hospital - Church Street Site

    Weston, Ontario, M9N 1N8

  • CancerCare Manitoba

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Belgium13 sites

  • OLVZ Medische Oncologie

    Aalst, 9300

  • Az. St. Jan

    Bruges, 8000

  • Cliniques Universitaires de Bruxelles

    Brussels, 1070

  • VZW Jesseziekenhuis - Campus Virga Jesse

    Hasselt, 3500

  • Jan Yperman Ziekenhuis

    Ieper, 8900

  • AZ Groeninge ampus Maria's Voorzienigheid (MV) Oncologisch Centrum

    Kortrijk, 8500

  • Centre Hospitalier Regional de La Citadelle

    Liège, 4000

  • CHU de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000

  • C.H.U. Ambroise Paré

    Mons, 7000

  • AZ Damiaan - Site Sint-Jozef

    Ostend, 8400

  • AZ Zusters van Barmhartigheid

    Ronse, 9600

  • AZ Nikolaas

    Sint-Niklaas, 9100

  • Sint-Elisabethziekenhuis

    Turnhout, 2300

Other trials in Belgium

United Kingdom13 sites

  • Queens Hospital

    Burton-on-Trent, Staffs, DE13 0RB

  • St James's University Hospital

    Leeds, LS9 7TF

  • University Hospitals of Leicester

    Leicester, LE1 5WW

  • St. Bartholomew's Hospital

    London, EC1A 7BE

  • Guy's Hospital

    London, SE1 9RT

  • Charing Cross Hospital, Department Of Medical Oncology

    London, W6 8RF

  • Christie Hospital

    Manchester, M20 4BX

  • Norfolk & Norwich University Hospitals

    Norwich, NR4 7UY

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Betsi Cadwaladr University Health Board

    Rhyl, Denbighshire, LL18 5UJ

  • Weston Park Hospital

    Sheffield, S10 2SJ

  • Singleton Hospital

    Swansea, SA2-8QA

  • Southend University Hospital

    Westcliff-on-Sea, SS0 0RY

Other trials in United Kingdom

Denmark12 sites

  • Aalborg Sygehus

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus C, 8000

  • Rigshospitalet

    Copenhagen, 2100

  • Sydvestjysk Sygehus

    Esbjerg, 6700

  • Herlev Hospital

    Herlev, 2730

  • Hillerod Hospital

    Hillerød, 3400

  • Næstved Sygehus

    Næstved, 4700

  • Odense Universitetshospital

    Odense C, 5000

  • Roskilde University Hospital

    Roskilde, 4000

  • Sygehus Sonderjylland

    Sønderborg, 6400

  • Vejle Sygehus

    Vejle, 7100

  • Regionshospital Viborg

    Viborg, 8800

Other trials in Denmark

Poland11 sites

  • Bialostockie Centrum Onkologii im. M. Sklodowskiej- Curie w Bialymstoku

    Bialystok, 15027

  • Centrum Onkologii im. prof. Franciszka Łukaszczyka

    Bydgoszcz, 85-796

  • Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"

    Bydgoszcz, 85796

  • Uniwersyteckie Centrum Kliniczne w Gdansku

    Gdansk, 80952

  • Szpital Morski im. PCK Gdynskie Centrum Onkologii Oddzial Chemioterapii

    Gdynia, 81519

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial

    Jelenia Góra, 58506

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w

    Krakow, 31531

  • Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w

    Olsztyn, 10228

  • Olsztynski Osrodek Onkologiczny Kopernik Sp. z o.o.

    Olsztyn, 10513

  • Szpital Wojewodzki im. Sw. Lukasza Samodzielny Publiczny Zaklad Opieki

    Tarnów, 33100

  • Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"

    Warsaw, 04125

Other trials in Poland

Turkey (Türkiye)10 sites

  • Gazi Universitesi Tip Fakultesi

    Besevler/Ankara, 06500

  • Ege Universitesi Tip Fakultesi

    Bornova/Izmir, 35100

  • Istanbul Universitesi Istanbul Tip Fakultesi

    Capa/Istanbul, 34390

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi, Ic Hastaliklari Anabilim Dali

    Cerrahpasa/Istanbul, 34098

  • Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi

    Demetevler/Ankara, 06200

  • Uludag Universitesi Tip Fakultesi

    Gorukle/Bursa, 16059

  • Dokuz Eylul Universitesi Tip Fakultesi

    Inciralti/Izmir, 35340

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

    Istanbul, 34890

  • Gaziantep Universitesi

    Sehitkamil/Gaziantep, 27310

  • Hacettepe Universitesi Tip Fakultesi

    Sihhiye/Ankara, 06100

Other trials in Turkey (Türkiye)

China9 sites

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021

  • Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

    Beijing, 100032

  • The Hospital Affiliated Academy Military Medical Science, Chinese People's

    Beijing, 100071

  • Chinese People's Liberation Army General Hospital

    Beijing, 100853

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060

  • Southern Medical University Nanfang Hospital

    Guangzhou, 510515

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Tianjin Cancer Hospital

    Tianjin, 300060

Other trials in China

Hungary9 sites

  • Semmelweis Egyetem Radiologiai és Onkoterapias Klinika

    Budapest, 1082

  • Fovarosi Onkormanyzat Szent Imre Korhaz

    Budapest, 1115

  • Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly

    Budapest, 1122

  • Bekes M. Kepviselotest. Pandy Kalman Korhaz, Megyei Onkol. Kp., Klin. Onkol. es Sugartherapias Oszt.

    Gyula, 5700

  • Kaposi Mor Oktato Korhaz, Onkologiai Centrum

    Kaposvár, 7400

  • Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

    Kecskemét, 6000

  • Borsod-Abauj-Zemplen M. Korhaz es Egyetemi Okt. K., Klin. Onk., Sugarterapias es Kozp. Szuro Centrum

    Miskolc, 3526

  • Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft. / Onkoradiologiai Osztaly

    Nyíregyháza, 4400

  • Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.

    Veszprém, 8200

Other trials in Hungary

Australia8 sites

  • The Queen Elizabeth Hospital

    Adelaide, South Australia, 5011

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3050

  • The Western Hospital

    Melbourne, Victoria, 3050

  • Hollywood Private Hospital

    Nedlands, Western Australia, 6009

  • North Adelaide Oncology Calvary Hospital North Adelaide

    North Adelaide, South Australia, 5006

  • Iron Cancer Care South Brisbane

    South Brisbane, Queensland, 4101

  • Sydney West Cancer Trials Centre

    Sydney, New South Wales, 2145

Other trials in Australia

Greece8 sites

  • University General Hospital of Alexandroupoli, Department of Medical Oncology

    Alexandroupoli, 68100

  • Hippokratio General Hospital of Athens

    Athens, 11527

  • Hippokration Hospital Athens

    Athens, 11527

  • General Hospital of Chania Ag. Georgios

    Chania, Crete, 73300

  • University Hospital of Heraklion

    Heraklion, Creete, 71110

  • University General Hospital of Larissa

    Larissa, 41110

  • University Hospital of Patras

    Rio Patras, 26500

  • Euromedica General Clinic

    Thessaloniki, 54645

Other trials in Greece

Netherlands7 sites

  • Ziekenhuis Amstelland

    Amstelveen, 1186 AM

  • Gelre ZH

    Apeldoorn, 7334 DZ

  • Amphia Ziekenhuis - Interne Geneeskunde

    Breda, 4819 EV

  • Maxima Medisch Centrum

    Eindhoven, 5631 BM

  • Vlietland Ziekenhuis

    Schiedam, 3118 JH

  • Orbis Medisch Centrum

    Sittard-Geleen, 6162 BG

  • Haga Ziekenhuis

    The Hague, 2545 CH

Other trials in Netherlands

Czechia6 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Masarykuv Onkologicky ustav

    Brno, 65653

  • Nemocnice Jihlava

    Jihlava, 58633

  • Institut Onkologie a Reahabilitace na Plesi

    Nová Ves pod Pleší, 26204

  • Multiscan s. r. o.

    Pardubice, 53003

  • Fakultni Nemocnice v Motole

    Prague, 15006

Other trials in Czechia

Bulgaria5 sites

  • District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD, Ist

    Plovdiv, 4004

  • District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD, Second

    Plovdiv, 4004

  • District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD

    Sofia, 1233

  • Specialised Hospital of Active Treatment in Oncology

    Sofia, 1756

  • Interdistrict Dispensary for Oncology Diseases

    Varna, 9000

Other trials in Bulgaria

Hong Kong5 sites

  • UNIMED Medical Institute, Comprehensive Centre for Breast Diseases

    Hong Kong, Wan Chai

  • Department of Clinical Oncology, Tuen Mun Hospital

    Hong Kong

  • Queen Mary Hospital, Department of Clinical Oncology, Professorial Block

    Hong Kong

  • Queen Mary Hospital, Department of Medicine, Blk K

    Hong Kong

  • Queen Mary Hospital, Department of Medicine

    Hong Kong

Other trials in Hong Kong

South Korea5 sites

  • National Cancer Center, Center for Breast Cancer

    Gyeonggi-do, 410-769

  • Samsung Medical Center

    Seoul, Korea, 135-710

  • Seoul National University Hospital, Department of Internal Medicine

    Seoul, 110-744

  • Korea University Anam Hospital, Department of Oncology/Hematology

    Seoul, 136-705

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Croatia4 sites

  • University Hospital Centre Osijek, Department of Radiotherapy and Oncology

    Osijek, 31000

  • General Hospital Varazdin

    Varaždin, 42000

  • Klinicki bolnicki centar "Sestre Milosrdnice"

    Zagreb, 10000

  • University Hospital Center Zagreb

    Zagreb, 10000

Other trials in Croatia

Israel4 sites

  • Soroka University MC, Department of Oncology

    Beersheba, 84101

  • Rambam Health care campus, Oncology institute

    Haifa, 31096

  • Kaplan Medical Center, Department of Oncology

    Rehovot, 76100

  • Sheba Medical Center, Oncology Institute Tel Hashomer

    Tel HaShomer, 52621

Other trials in Israel

Switzerland4 sites

  • Hirslanden Medical Center Tumor Center

    Aarau, 5000

  • Kantonsspital Baden

    Baden, 5404

  • Kantonsspital Olten-Medizinische Onkologie

    Olten, 4600

  • Spital STS AG

    Thun, 3600

Other trials in Switzerland

Colombia3 sites

  • Administradora Country S.A-Clinica del Country

    Bogotá

  • Oncomedica S.A. IMAT

    Montería, Departamento de Córdoba

  • Oncologos del Occidente

    Pereira, Risaralda Department

Other trials in Colombia

Romania3 sites

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 050098

  • Institutul Oncologic "Prof. Dr. Ion Chiricuta"

    Cluj-Napoca, Cluj, 400015

  • SC Oncolab S.R.L.

    Craiova, Dolj, 200385

Other trials in Romania

Slovakia3 sites

  • Interna onkologicka klinika

    Bratislava, 81250

  • Oddelenie radioterapie a onkologie

    Košice, 04191

  • Poliklinika ADUS

    Poprad, 05801

Other trials in Slovakia

Taiwan3 sites

  • Kaohsiung Medical University Chung-Ho memorial Hospital

    Kaohsiung City, 807

  • Chang Gung Medical Foundation, Linkou Branch

    Kwei-Shan, Taoyuan, 333

  • National Taiwan University Hospital

    Taipei TOC, 100

Other trials in Taiwan

Lithuania2 sites

  • The Hospital of Lithuanian University of Health Sciences Kauno klinikos Oncology and Haematology Clinic

    Kaunas, LT-50161

  • Oncology Institute of Vilnius University

    Vilnius, LT-08661

Other trials in Lithuania

Serbia2 sites

  • Institute of Oncology and Radiology of Serbia

    Belgrade, 11000

  • Clinical centre Nis

    Niš, 18000

Other trials in Serbia

Sweden2 sites

  • Onkologiska Kliniken

    Lund, 22185

  • Skanes Onkologiska Kliniken

    Lund, 22185

Other trials in Sweden

Brazil1 site

  • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90610-000

Other trials in Brazil

Malaysia1 site

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

Other trials in Malaysia

Malta1 site

  • Sir Paul Boffa Hospital

    Floriana, VLT 14

Other trials in Malta

Mexico1 site

  • Nucleo de Especialidades Oncológicas

    Guadalajara, Jalisco, 44670

Other trials in Mexico

New Zealand1 site

  • Auckland Hospital

    Auckland, 1023

Other trials in New Zealand

North Macedonia1 site

  • University Clinic for Radiotherapy and Oncology

    Skopje, 1000

Other trials in North Macedonia

Peru1 site

  • Clínica Vista Alegre / Unidad de Investigacion

    Surco, Lima region, 33

Other trials in Peru

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, 169610

Other trials in Singapore

The Bahamas1 site

  • Affinity Research Limited

    Nassau, 13932

About this study

Official title: 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

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.

Conditions
Breast Cancer
Being tested
neratinib, placebo
Keywords
HER-2/erbB-2 positive breast cancer, breast cancer, adjuvant therapy, neratinib, HKI-272, Nerlynx, PB-272
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • neratinibDrug

    Also called HKI-272, Nerlynx

  • placeboOther

Study groups in NCT00878709
Study groupRoleWhat they receive
NeratinibExperimental240 mg orally daily for one year
Receives: Drug: neratinib
PlaceboPlacebo comparatororally daily for one year
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From randomization until time of event up to 2 years

  2. Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms

    Measured: From randomization until time of event up to 2 years

Secondary outcomes (9)

  1. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause, censored at the last date known alive.

    Measured: Randomization until death due to any cause (up to 119 Months)

  2. 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.

    Measured: From randomization until time of event up to 2 years

  3. Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms

    Measured: From randomization until time of event up to 2 years

  4. 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.

    Measured: From randomization until time of event up to 2 years

  5. Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms

    Measured: From randomization until time of event up to 2 years

  6. 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.

    Measured: From randomization until time of event up to 2 years

  7. Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms

    Measured: From randomization until time of event up to 2 years

  8. 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.

    Measured: From randomization until time of event up to 2 years

  9. 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).

    Measured: From randomization until time of event up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2009 (estimated)
  2. Study start9 Jul 2009
  3. Primary completion21 Aug 2014
  4. Study completion4 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,840 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00878709
Sponsor's protocol ID
3144A2-3004 / B1891004
Acronym
ExteNET
Status last verified
May 2021
First submitted
8 Apr 2009
Last updated
11 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 36898233

  • Iwata 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.

    PubMed 31140297

  • Chia 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.

    PubMed 30867034

  • Mortimer 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.

    PubMed 30813966

  • Delaloge 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.

    PubMed 30689703

  • Martin 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.

    PubMed 29146401

  • Chan 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.

    PubMed 26874901

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing neratinib in people with Breast Cancer, run by Puma Biotechnology, Inc. at 494 sites in 40 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 494 sites in United States, Germany, Spain, Japan, France and 35 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 (time frame: From randomization until time of event up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00878709, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.

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