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Spots Global Cancer Trial Database for Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

The following info and data is provided "as is" to help patients around the globe.
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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

Useful links and downloads for this trial

Clinicaltrials.gov

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