Spots Global Cancer Trial Database for Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer
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Trial Identification
Brief Title: Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer
Official Title: A Phase 2 Randomized Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine For The Treatment Of ErbB-2 Positive Locally Advanced Or Metastatic Breast Cancer
Study ID: NCT00777101
Study Description
Brief Summary: This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, Wien, , 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, Quebec, , Canada
General Hospital Varazdin, Varazdin, , 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 Benite, , 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, Thessaloníki, , 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, Kecskemet, , Hungary
Josa Andras Oktatokorhaz / Onkoradiologiai Osztaly, Nyiregyhaza, , Hungary
Szegedi Tudomanyegyetem Onkoterapias Klinika, Szeged, , Hungary
Hospital of County Veszprem, Veszprem, , 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, Hyogo, , 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
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Samsung Medical Center, Seoul, Korea, Korea, Republic of
Yonsei University Health System - Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Oca Hospital / Monterrey International Research Center, Monterrey, Nuevo Leon, 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, , Puerto Rico
Institutul Oncologic "Prof. Dr. Alex. Trestioreanu", Bucuresti, , Romania
Spitalul Universitar de Urgenta, Bucuresti, , Romania
Centrul de Oncologie Medicala, Iasi, , Romania
Spitalul Clinic Judetean, Sibiu, , Romania
Scientific Research Institute of Oncology N.N. Petrov, Pesochny, Saint Petersburg, Russian Federation
Russian Oncology Research Centre of RAMS, Moscow, , Russian Federation
GUZ Perm Regional Oncology Dispensary, Perm, , Russian Federation
Ryazan State Medical University I.P.Pavlov of Federal Agency in Healthcare and Social Development, Ryazan, , Russian Federation
SIH Leningrad Regional Oncology Dispensary, Saint Petersburg, , Russian Federation
GUZ City Clinical Oncology Dispensary, Saint Petersburg, , Russian Federation
St. Petersburg State Medical University I.P.Pavlov of Roszdrav, Saint Petersburg, , Russian Federation
SIH Oncology Dispensary # 2 Of Department of Public Health, Sochi, , Russian Federation
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Bashkortostan Republic, Ufa, , Russian Federation
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 Province, South Africa
Hospital Central de Asturias Servicio de Oncologia, Planta Baja Oeste, Edificio Principal, Oviedo, Asturias, Spain
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
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, Caceres, , Spain
Hospital Provincial (Reina Sofia) Servicio de Oncologia, Cordoba, , Spain
Hospital Universitario Dr. Josep Trueta Servicio de Oncologia, Gerona, , Spain
Centro Hospitalario de Jaen Servicio de Oncologia, Jaen, , 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, Zuerich, , 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
Contact Details
Name: Puma
Affiliation: Biotechnology
Role: STUDY_DIRECTOR
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