Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer
NCT ID: NCT00777101
Last Updated: 2018-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
233 participants
INTERVENTIONAL
2009-02-04
2018-06-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Neratinib
Neratinib
Tablets 240 mg orally once per day until disease progression or unacceptable toxicity
Lapatinib plus Capecitabine
Lapatinib
Tablets 1250 mg orally once per day until disease progression or unacceptable toxicity.
Capecitabine
Tablets 2000 mg/m² given orally in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
Interventions
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Neratinib
Tablets 240 mg orally once per day until disease progression or unacceptable toxicity
Lapatinib
Tablets 1250 mg orally once per day until disease progression or unacceptable toxicity.
Capecitabine
Tablets 2000 mg/m² given orally in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior use of Herceptin (trastuzumab), and a taxane
* Adequate cardiac and renal function
Exclusion Criteria
* Bone as the only site of disease
* Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
* Significant gastrointestinal disorder with diarrhea as major symptom
18 Years
FEMALE
No
Sponsors
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Puma Biotechnology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Puma
Role: STUDY_DIRECTOR
Biotechnology
Locations
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Arizona Oncology Associates HOPE
Tucson, Arizona, United States
Southwest Cancer Care
Murrieta, California, United States
UC Irvine Medical Center
Orange, California, United States
Aptium Oncology/Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States
Redwood Regional Medical Group, Inc.
Santa Rosa, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Hematology Oncology Associates, P.C.
Stamford, Connecticut, United States
Palm Beach Institute of Hematology & Oncology
Boynton Beach, Florida, United States
Robert R. Carroll, MD, PA
Gainesville, Florida, United States
University of Florida
Jacksonville, Florida, United States
Hematology Oncology Associates
Loxahatchee Groves, Florida, United States
Mercy Research Institute
Miami, Florida, United States
Cancer Centers of Florida
Orlando, Florida, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
Cancer Care Specialists Of Central Illinois
Decatur, Illinois, United States
Oncology Specialists, SC
Park Ridge, Illinois, United States
Midwestern Regional Medical Center
Zion, Illinois, United States
Central Indiana Cancer Centers
Fishers, Indiana, United States
Hematology Oncology of Indiana
Indianapolis, Indiana, United States
Floyd Memorial Cancer Center of Indiana
New Albany, Indiana, United States
Ashland-Bellefonte Cancer Center
Ashland, Kentucky, United States
Owsley Brown Frazier Cancer Center (OBFCC)
Louisville, Kentucky, United States
Purchase Cancer Group
Paducah, Kentucky, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States
Arena Oncology Associates, PC
Lake Success, New York, United States
Weill Cornell Medical College New York-Presbyterian Hospital Weill, Cornell Breast Center
New York, New York, United States
New York Oncology Hematolgy, PC
Troy, New York, United States
Oncology Partners Network
Cincinnati, Ohio, United States
MetroHealth Medical Center, Cancer Care Center
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center Dept. of Hematology Oncology
Oklahoma City, Oklahoma, United States
Northwest Cancer Specialists, PC
Portland, Oregon, United States
Lancaster Cancer Center
Lancaster, Pennsylvania, United States
Allegheny General Hospital Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States
Cookeville Regional Medical Center
Cookeville, Tennessee, United States
Center for Biomedical Research
Knoxville, Tennessee, United States
Thompson Cancer Survival Center Thompson Oncology Group
Knoxville, Tennessee, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, United States
Texas Oncology, P.A.
Austin, Texas, United States
El Paso Cancer Treatment Center - West
El Paso, Texas, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
HOPE Oncology
Richardson, Texas, United States
Cancer Care Network of South Texas-HOAST
San Antonio, Texas, United States
East Texas Medical Center Cancer Institute, Tyler Hematology Oncology
Tyler, Texas, United States
Mater Private Centre for HOCA
South Brisbane, Queensland, Australia
Medical Oncology Royal Adelaide Hospital
Adelaide, South Australia, Australia
Western Hospital
Footscray, Victoria, Australia
Mount Hospital
West Perth, , Australia
AKH Wien Universitaetsklinik fuer Innere Medizin I Klinische Abteilung für Onkologie
Vienna, , Austria
Institut Jules Bordet Unite du Chimiotherapie
Brussels, , Belgium
District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD, Dept. of Chemotherapy
Sofia, , Bulgaria
UMHAT Tzaritza Yoanna
Sofia, , Bulgaria
Interdistrict Dispensary for Oncology Diseases -Internal Unit- Department Oncotherapy and Palliative Care
Varna, , Bulgaria
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada
Centre Hospitalier Affilie Universitaire de Quebec Hopital du St-Sacrement
Québec, Quebec, Canada
General Hospital Varazdin
Varaždin, , Croatia
University Hospital Center Zagreb
Zagreb, , Croatia
University Hospital Sestre Milosrdnice
Zagreb, , Croatia
Fakultni nemocnice Olomouc Klinika onkologie
Olomouc, , Czechia
Centre Oscar Lambret Departement de senologie
Lille, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU de Poitiers Service d'oncologie medicale
Poitiers, , France
Institut Gustave ROUSSY Service de Pathologie mammaire
Villejuif, , France
Universitaetsklinikum Hamburg-Eppendorf Klinik und Poliklinik fuer Gynaekologie
Hamburg, , Germany
Nationales Centrum fuer Tumorerkrankungen Sektion Gynaekologische Onkologie
Heidelberg, , Germany
Theagenio Anticancer Hospital of Thessaloniki
Thessaloniki, , Greece
Department of Clinical Oncology, Tuen Mun Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
UNIMED Medical Institute, Comprehensive Centre for Breast Diseases
Hong Kong, , Hong Kong
Fovarosi Onkormanyzat Szent Janos Korhaza es Eszak-budai Egyesitett Korhazai, Onkologia
Budapest, , Hungary
Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly
Budapest, , Hungary
Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont
Kecskemét, , Hungary
Josa Andras Oktatokorhaz / Onkoradiologiai Osztaly
Nyíregyháza, , Hungary
Szegedi Tudomanyegyetem Onkoterapias Klinika
Szeged, , Hungary
Hospital of County Veszprem
Veszprém, , Hungary
Ospedale Misericordia e Dolce c/o UO Oncologia Medica
Prato, , Italy
Istituto Regina Elena, Struttura Complessa Oncologia Medica A
Roma, , Italy
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
National Cancer Center Hospital
Tsukiji, Tokyo, Japan
Aichi Cancer Center
Aichi, , Japan
Chiba Cancer Center
Chiba, , Japan
National Cancer Center Hospital East
Chiba, , Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Hiroshima City Hospital
Hiroshima, , Japan
Hyogo Cancer Center
Hyōgo, , Japan
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima, , Japan
Tokai University Hospital
Kanagawa, , Japan
Kumamoto Municipal Hospital
Kumamoto, , Japan
Kyoto University Hospital
Kyoto, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
Saitama Cancer Center
Saitama, , Japan
Shizuoka Cancer Center
Shizuoka, , Japan
Jichi Medical University Hospital
Tochigi, , Japan
St. Luke's International Hospital
Tokyo, , Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research Department of Medical Oncology
Tokyo, , Japan
Tokyo Metropolitan Cancer&Infectious disease Ctr Komagome Hp
Tokyo, , Japan
King Hussein Cancer Centre
Amman, , Jordan
Oca Hospital / Monterrey International Research Center
Monterrey, Nuevo León, Mexico
Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie w Bialymstoku Specjalistyczny Szpital Onkologiczn
Bialystok, , Poland
Uniwersyteckie Centrum Kliniczne w Gdansku Klinika Onkologii i Radioterapii
Gdansk, , Poland
Szpital Uniwersytecki w Krakowie Oddzial KIiniczny Kliniki Onkologii
Krakow, , Poland
Centrum Onkologii Ziemi Lubelskiej im. SW. Jana z Dukli
Lublin, , Poland
Metropolitan Oncology Center
San Juan, PR, Puerto Rico
Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"
Bucharest, , Romania
Spitalul Universitar de Urgenta
Bucharest, , Romania
Centrul de Oncologie Medicala
Iași, , Romania
Spitalul Clinic Judetean
Sibiu, , Romania
Scientific Research Institute of Oncology N.N. Petrov
Pesochny, Sankt-Peterburg, Russia
Russian Oncology Research Centre of RAMS
Moscow, , Russia
GUZ Perm Regional Oncology Dispensary
Perm, , Russia
Ryazan State Medical University I.P.Pavlov of Federal Agency in Healthcare and Social Development
Ryazan, , Russia
SIH Leningrad Regional Oncology Dispensary
Saint Petersburg, , Russia
GUZ City Clinical Oncology Dispensary
Saint Petersburg, , Russia
St. Petersburg State Medical University I.P.Pavlov of Roszdrav
Saint Petersburg, , Russia
SIH Oncology Dispensary # 2 Of Department of Public Health
Sochi, , Russia
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Bashkortostan Republic
Ufa, , Russia
Institute of Oncology and Radiology of Serbia
Belgrade, , Serbia
Klinicko Bolnicki Centar (KBC) Bezanijska Kosa (Medical Centre ''Bezanijska Kosa'' (MCBK))
Belgrade, , Serbia
Johns Hopkins Singapore International Medical Centre
Singapore, , Singapore
Institute for Oncology Department for Medical Oncology
Ljubljana, , Slovenia
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, South Africa
Eastleigh Breast Care Centre
Lynnwood, Gauteng, South Africa
Hopelands Oncology Centre
Durban, KwaZulu-Natal, South Africa
GVI Oncology Trial Unit Room 110 Panorama Medical Centre
Kraaifontein, Western Cape, South Africa
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Samsung Medical Center
Seoul, Korea, South Korea
Yonsei University Health System - Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Germans Trias i Pujol Servicio de Oncologia
Badalona, Barcelona, Spain
Corporacio Sanitaria Parc Tauli Servicio de Oncologia
Sabadell, Barcelona, Spain
Hospital Mutua de Terrassa Servicio de Oncologia
Terrassa, Barcelona, Spain
Hospital Central de Asturias Servicio de Oncologia, Planta Baja Oeste, Edificio Principal
Oviedo, Principality of Asturias, Spain
Complejo Hospitalario U. de A Coruña Hospital Teresa Herrera Servicio de Oncologia
A Coruña, , Spain
Hospital General Universitario de Alicante Servicio de Oncologia
Alicante, , Spain
Hospital San Pedro de Alcantara Servicio de Oncologia
Cáceres, , Spain
Hospital Provincial (Reina Sofia) Servicio de Oncologia
Córdoba, , Spain
Hospital Universitario Dr. Josep Trueta Servicio de Oncologia
Girona, , Spain
Centro Hospitalario de Jaen Servicio de Oncologia
Jaén, , Spain
Hospital Gregorio Marañon Servicio de Oncologia
Madrid, , Spain
Centro Oncologico M.D. Anderson Internacional
Madrid, , Spain
Instituto Valenciano de Oncologia Servicio de Oncologia
Valencia, , Spain
Hospital Clinico Universitario de Valencia Servicio de Hematologia y Oncologia
Valencia, , Spain
Hospital Universitario Miguel Servet Servicio de Oncologia
Zaragoza, , Spain
University of Lausanne Hospitals CHUV
Lausanne, , Switzerland
Kantonsspital Winterthur Medizinische Onkologie
Winterthur, , Switzerland
Abteilung fuer Onkologie Departement für Innere
Zurich, , Switzerland
National Taiwan University Hospital
Taipei, , Taiwan
Division of Medical Oncology, Department of Medicine
Bangkok Noi, Bangkok, Thailand
Broomfield Hospital
Chelmsford, Essex, United Kingdom
Royal Marsden NHS Foundation Trust & Institute of Cancer Research
London, , United Kingdom
The Royal Marsden NHS Foundation Trust & Institute of Cancer Research
London, , United Kingdom
Countries
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References
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Martin M, Bonneterre J, Geyer CE Jr, Ito Y, Ro J, Lang I, Kim SB, Germa C, Vermette J, Wang K, Wang K, Awada A. A phase two randomised trial of neratinib monotherapy versus lapatinib plus capecitabine combination therapy in patients with HER2+ advanced breast cancer. Eur J Cancer. 2013 Dec;49(18):3763-72. doi: 10.1016/j.ejca.2013.07.142. Epub 2013 Aug 15.
Other Identifiers
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3144A2-3003 / B1891003
Identifier Type: -
Identifier Source: org_study_id
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