Spots Global Cancer Trial Database for A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting
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Trial Identification
Brief Title: A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting
Official Title: A STUDY OF NERATINIB PLUS CAPECITABINE VERSUS LAPATINIB PLUS CAPECITABINE IN PATIENTS WITH HER2+ METASTATIC BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR HER2-DIRECTED REGIMENS IN THE METASTATIC SETTING (NALA)
Study ID: NCT01808573
Conditions
Study Description
Brief Summary: This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.
Detailed Description: This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting. Patients will be randomized in a 1:1 ratio to one of the following treatment arms: * Arm A: neratinib (240 mg once daily) + capecitabine (1500 mg/m\^2 daily, 750 mg/m\^2 twice daily \[BID\]) * Arm B: lapatinib (1250 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID) Patients will receive either neratinib plus capecitabine combination or lapatinib plus capecitabine combination until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ironwood Cancer and Research Centers, Chandler, Arizona, United States
Ironwood Cancer and Research Centers, Gilbert, Arizona, United States
Ironwood Cancer and Research Centers, Mesa, Arizona, United States
Ironwood Cancer and Research Centers, Scottsdale, Arizona, United States
UCLA Hematology Oncology, Alhambra, California, United States
CBCC Global Research, Inc. at Comprehensive Blood and Caner Center, Bakersfield, California, United States
Compassionate Cancer Care Medical Group Inc., Fountain Valley, California, United States
St. Jude Heritage Medical Group, Fullerton, California, United States
St. Jude Heritage Medical Group, Fullerton, California, United States
Marin Cancer Care, Inc., Greenbrae, California, United States
UCLA Hematology Oncology, Irvine, California, United States
University of California San Diego Medical Center, La Jolla, California, United States
University of California San Diego Moores Cancer Center, La Jolla, California, United States
Breastlink Medical Group, Inc., Orange, California, United States
UCLA Hematology Oncology, Pasadena, California, United States
UCLA Hematology Oncology, Porter Ranch, California, United States
Emad Ibrahim, MD, Redlands, California, United States
Cancer Care Associates Medical Group, Inc, Redondo Beach, California, United States
Compassionate Cancer Care Medical Group, Riverside, California, United States
University of California San Diego Medical Center - Hillcrest, San Diego, California, United States
Sharp Memorial Hospital, San Diego, California, United States
Breastlink Medical Group, Inc., Santa Ana, California, United States
Cancer Center of Santa Barbara Sansum Clinic, Santa Barbara, California, United States
Central Coast Medical Oncology, Santa Maria, California, United States
UCLA Hematology Oncology, Santa Monica, California, United States
Cancer Center of Santa Barbara, Solvang, California, United States
UCLA Healthcare Santa Clarita Oncology, Valencia, California, United States
UCLA Hematology/Oncology, Westlake Village, California, United States
Sibley Memorial Hospital, Washington, District of Columbia, United States
Broward Medical Oncology Office, Plantation, Florida, United States
Florida Cancer Research Institute, Plantation, Florida, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Emory Clinic, Atlanta, Georgia, United States
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
OnCare Hawaii, Honolulu, Hawaii, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Honolulu, Hawaii, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Resurrection Medical Group, Chicago, Illinois, United States
North Shore Oncology-Hematology Associates, Ltd., Crystal Lake, Illinois, United States
Primary Healthcare Associates, SC, Harvey, Illinois, United States
North Shore Hematology Oncology, Highland Park, Illinois, United States
North Shore Oncology-Hematology Associates, Ltd., Libertyville, Illinois, United States
Orchard Healthcare Research Inc, Skokie, Illinois, United States
Primary Health Oncology, Hobart, Indiana, United States
St. Mary Medical Center, Hobart, Indiana, United States
Community Hospital, Munster, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at John Hopkins at Greenspring Station, Lutherville, Maryland, United States
The Cancer Institute at University of Maryland St. Joseph Medical Center, Towson, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Washington University in St. Louis, Saint Louis, Missouri, United States
Siteman Cancer Center - South County, Saint Louis, Missouri, United States
Siteman Cancer Center - West County, Saint Louis, Missouri, United States
Siteman Cancer Center - St. Peters, Saint Peters, Missouri, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
North Shore Hematology Oncology Association PC, East Setauket, New York, United States
Clinical Research Alliance, Lake Success, New York, United States
NYU Langone Medical Center, Lake Success, New York, United States
Clinical Research Alliance, Inc., New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
University Hospitals Case Medical Center, Orange Village, Ohio, United States
UPMC Cancer Pavillion, Greensburg, Pennsylvania, United States
Hershey Medical Center, Hershey, Pennsylvania, United States
UPMC Cancer Pavillion, Monroeville, Pennsylvania, United States
Magee Women's Hospital, Pittsburgh, Pennsylvania, United States
UPMC Cancer Pavillion, Pittsburgh, Pennsylvania, United States
Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
UPMC Cancer Pavillion, Pittsburgh, Pennsylvania, United States
UPMC Cancer Pavillion, Uniontown, Pennsylvania, United States
UPMC Cancer Pavillion, West Mifflin, Pennsylvania, United States
West Clinic PC, Germantown, Tennessee, United States
West Clinic PC, Memphis, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
COIBA Centro de Oncología e Investigación Buenos Aires, Berazategui, Buenos Aires, Argentina
Fundación Investigar, Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
The Tweed Hospital, Tweed Heads, New South Wales, Australia
Sunshine Coast University Hospital, Birtinya, Queensland, Australia
Bankstown-Lidcombe Hospital, Bankstown, , Australia
St. George Hospital, Kogarah, , Australia
Box Hill Hospital, Oncology Department, Melbourne, , Australia
Maroondah Hospital, Maroondah Breast Clinic, Melbourne, , Australia
Sydney Adventist Hospital, Wahroonga, , Australia
University Hospital Innsbruck - Tyrolean Hospital, Department of Gynecology, Innsbruck, , Austria
Our Dear Lady Hospital, Aalst Campus, Aalst, , Belgium
Institut Jules Bordet - Medical Oncology, Brussels, , Belgium
University Hospital Saint-Luc, Brussels, , Belgium
Antwerp University Hospital, Edegem, , Belgium
Leuven University Hospitals, Leuven, , Belgium
Clinic Saint-Joseph, Liege, , Belgium
St. Elizabeth Maternity Clinic, Namur, , Belgium
AZ Damiaan General Hospital, Sint-Jozef Oncology Center, Ostend, , Belgium
Saint-Augustinus Hospital, Wilrijk, , Belgium
Núcleo de Oncologia da Bahia - NOB, Salvador, Bahia, Brazil
Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética, Salvador, Bahia, Brazil
Centro Regional Integrado de Oncologia, Fortaleza, Ceara, Brazil
Hospital Araújo Jorge, Associação de Combate ao Câncer em Goiás, Goiânia, Goiás, Brazil
Liga Paranaense de Combate ao Cancer, Hospital Erasto Gaertner, Curitiba, Parana, Brazil
Instituto de Pesquisas Clinicas para Estudos Multicentricos Hospital Geral de Caxias do Sul, Universidade de Caxias do Sul (IPCEM), Caxias do Sul, Rio Grande Do Sul, Brazil
Hospital Sao Lucas da PUCRS, Porto Alegre, Rio Grande Do Sul, Brazil
Instituto Joinvillense de Hematologia e Oncologia, Joinville, Santa Catarina, Brazil
Hospital de Cancer de Barretos - Hospital, Barretos, Sao Paulo, Brazil
Instituto Ribeiraopretano de Combate Ao Cancer - Clinic/Outpatient Facility, Ribeirao Preto, Sao Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto, Hospital de Base, São José Do Rio Preto, São Paulo, Brazil
Hospital Do Cancer A C Camargo - Hospital, São Paulo, , Brazil
Instituto Brasileiro de Controle Do Câncer IBCC, São Paulo, , Brazil
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Abbotsford Regional Hospital and Cancer Care Centre, Abbotsford, British Columbia, Canada
British Columbia Cancer Agency, Kelowna, British Columbia, Canada
Fraser Health Authority, Surrey, British Columbia, Canada
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
Grand River Hospital, Kitchener, Ontario, Canada
Ottawa Hospital, Cancer Center, Ottawa, Ontario, Canada
Toronto East General Hospital, Toronto, Ontario, Canada
Sunnybrook Health Sciences Center, Odette Cancer Center, Toronto, Ontario, Canada
St. Michael's Hospital, Toronto, Ontario, Canada
CHUM Notre Dame Hospital, Montreal, Quebec, Canada
Montreal General Hospital, Montreal, Quebec, Canada
Centre hospitalier affilié universitaire de Québec - Hôpital du Saint-Sacrement, Québec City, Quebec, Canada
Masaryk Memorial Cancer Institute, Brno, , Czechia
Hospital Novy Jicin, Novy Jicin, , Czechia
University Hospital Motol, Comprehensive Oncology Center, Prague, , Czechia
Sjaelland University Hospital, Naestved, , Denmark
Helsinki University Central Hospital, Department of Oncology, Helsinki, , Finland
South Lyon Hospital Center, Department of Clinical Hematology and Medical Oncology, Pierre-Benite, Lyon, France
Center Jean Perrin, Clermont-Ferrand, , France
Saint-Louis Hospital, Paris, , France
Clinic Sainte Anne, Center for Radiotherapy, Strasbourg, , France
Gustave Roussy Oncology Institute, Department of Medicine, Villejuif, , France
Hematology-Oncology Practice, Augsburg, , Germany
Practice for Oncology Bielefeld, Bielefeld, , Germany
University Hospital Cologne, Breast Center, Clinic of Obstetrics and Gynecology, Cologne, , Germany
University Hospital Schleswig-Holstein, Kiel, , Germany
Otto von Guericke University of Magdeburg, Magdeburg, , Germany
Onkologie Ravensburg, Ravensburg, , Germany
University Hospital Ulm, Ulm, , Germany
Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Queen Elizabeth Hospital, Department of Clinical Oncology, Hong Kong, , Hong Kong
Queen Mary Hospital, Department of Clinical Oncology, Hong Kong, , Hong Kong
Queen Mary Hospital, Department of Oncology, Hong Kong, , Hong Kong
Queen Mary Hospital, Department of Surgery, Hong Kong, , Hong Kong
Tuen Mun Hospital, Hong Kong, , Hong Kong
St. Jame's Hospital, Dublin, , Ireland
St. Vincent's University Hospital, Dublin, , Ireland
Soroka Medical Center, Beersheba, , Israel
Rambam Medical Center, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Meir Medical Center, Kfar-Saba, , Israel
Rabin Medical Center, Belinson Hospital, Petah Tikva, , Israel
Kaplan Medical Center, Department of Oncology, Rehovot, , Israel
Chaim Sheba Medical Center, Tel Hashomer, , Israel
Sourasky Medical Center, Department of Oncology, Tel-Aviv, , Israel
Ziv Medical Center, Zefat, , Israel
Hospital Papa Giovanni XXIII, Department of Medical Oncology, Bergamo, , Italy
Hospital Cervesi di Cattolica, Department of Oncology, Cattolica, , Italy
University G. D'Annunzio Chieti Pescara, Chieti, , Italy
Scientific Institute of Romagna of the Study and Treatment of Cancer, Meldola, , Italy
IRCCS - Hospital San Raffaele, Department of Medical Oncology, Milan, , Italy
European Institute of Oncology, Milan, , Italy
Azienda Ospedaliero San Gerardo, Monza, , Italy
National Cancer Institute - IRCCS "Fondazione G. Pascale", Naples, , Italy
Hospital Sacro Cuore Don Calabria, Department of Medical Oncology, Negrar, , Italy
Azienda Ospedaliera Regionale San Carlo, Potenza, , Italy
Hospital Bianchi Melacrino Morelli, Reggio Calabria, , Italy
Hospital Infermi Rimini, Unit of Oncology, Rimini, , Italy
University Hospital Campus Bio-Medico, Rome, , Italy
National Cancer Institute Regina Elena, Rome, , Italy
Institute of Cancer Research and Treatment, Torino, , Italy
Hospital Desio and Vimercate, Department of Medical Oncology, Vimercate, , Italy
Chiba University Hospital, Chiba-shi, Chiba, Japan
Kobe City Medical Center General Hospital, Kobe-City, Hyôgo, Japan
University of Tsukuba Hospital, Tsukuba, Ibaraki, Japan
Iwate Medical University Hospital, Morioka, Iwate, Japan
Tokai University Hospital, Isehara, Kanagawa, Japan
Kumamoto University Hospital, Kumamoto-shi, Kumamoto, Japan
Saitama Cancer Centre, Kitaadachi-gun, Saitama, Japan
JCHO Kurume General Hospital, Fukuoka, , Japan
Gunma University Hospital, Gunma, , Japan
Hiroshima City Hospital, Hiroshima, , Japan
National Hospital Organization Hokkaido Cancer Center, Hokkaido, , Japan
Hakuaikai Medical Corporation Sagara Hospital, Kagoshima-city, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Toramonon Hospital, Tokyo, , Japan
National Hospital Organization Osaka National Hospital, Ôsaka, , Japan
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Maastricht University Medical Centre (MUMC), Maastricht, , Netherlands
Centro de Investigação Clinica, Hospital da Luz, Lisboa, , Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE, Lisbon, , Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E., Porto, , Portugal
Federal State Government-Financed Institution: City Clinical Hospital #40, Moscow, Moskva, Russian Federation
Russian Oncological Research Center n.a. N.N. Blokhin Russian Academy of Medical Sciences, Moscow, , Russian Federation
Tambov Regional Oncological Center, Tambov, , Russian Federation
National University Hospital, Singapore, , Singapore
National Cancer Centre Singapore, Department of Medical Oncology, Singapore, , Singapore
Raffles Hospital, Singapore, , Singapore
Icon Singapore Oncology Consultants Farrer Park Medical Clinic, Singapore, , Singapore
Gleneagles Medical Centre, Center for Medical Oncology, Singapore, , Singapore
Parkway Cancer Centre, Singapore, , Singapore
Johns Hopkins Singapore International Medical Center, Singapore, , Singapore
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Consorcio Hospitalario Provincial de Castellon, Castellon de la Plana, , Spain
Hospital Universitari de Girona Dr. Josep Trueta (ICO Girona), Servicio de Oncologia, Girona, , Spain
Complejo Hospitalario Universitario Insular-Materno Infantil, Las Palmas de Gran Canaria, , Spain
Centro Oncologico MD Anderson, Madrid, , Spain
University Hospital Clinic San Carlos, Servicio de Oncologia Medica, Madrid, , Spain
University Hospital 12 de Octubre, Servicio de Oncologia - Edificio Maternidad, 2ª planta, Madrid, , Spain
Centro Integral Oncologico Clara Campal, Madrid, , Spain
University Hospital Quiron Madrid, Department of Oncology, Madrid, , Spain
Hospital Universitario Virgen de la Arrixaca, Servicio de Oncologia, Murcia, , Spain
Hospital Universitario Son Espases, Palma de Mallorca, , Spain
Hospital Son Llatzer, Servicio de Oncologia, Palma de Mallorca, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
University Hospital Virgen del Rocio, Servicio de Oncologia, Sevilla, , Spain
Hospital Clinico Universitario de Valencia, Servicio de Oncologia, Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa, Servicio de Oncologia, Zaragoza, , Spain
Orebro University Hospital, Department of Oncology, Orebro, , Sweden
Uppsala University Hospital, Department of Oncology, Uppsala, , Sweden
Hospital Engeried, Bern, , Switzerland
University Hospital of Geneva, Geneva, , Switzerland
Canton Hospital Winterthur, Winterthur, , Switzerland
Onkozentrum Zurich - Kinik im Park, Zurich, , Switzerland
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Province Of China, Taiwan
Taichung Veterans General Hospital, Breast Center, Taichung, Province Of China, Taiwan
National Cheng Kung University Hospital, Tainan, Province Of China, Taiwan
Chi Mei Medical Center - YK Branch, Tainan, Province Of China, Taiwan
Chi Mei Medical Center - LiouYing Branch, Tainan, Province Of China, Taiwan
Mackay Memorial Hospital, Taipei, Province Of China, Taiwan
Tri-Service General Hospital, Taipei, Province Of China, Taiwan
Changhua Christian Hospital, Changhua, Taiwan, Province Of China, Taiwan
Buddhist Tzu-Chi General Hospital, Hualien, Taiwan, Province Of China, Taiwan
Chung-Ho Memorial Hospital, Kaohsiung, Taiwan, Province Of China, Taiwan
Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, Province Of China, Taiwan
Taipei Tzu Chi General Hospital, New Taipei City, , Taiwan
Kuang Tien General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Ege University, Bornova, Izmir, Turkey
Marmara University Faculty of Medicine, Istanbul, , Turkey
Colchester General Hospital, Colchester, Essex, United Kingdom
Queen Elizabeth Hospital Birmingham, Birmingham, West Midlands, United Kingdom
Velindre Cancer Centre, Cardiff, , United Kingdom
Calderdale Royal Hospital, Macmillan Unit, Halifax, , United Kingdom
Huddersfield Royal Infirmary, Huddersfield, , United Kingdom
Nottingham City Hospital Campus, Department of Oncology, Nottingham, , United Kingdom
Contact Details
Name: Senior Vice President Clinical Science and Pharmacology
Affiliation: Puma Biotechnology, Inc.
Role: STUDY_DIRECTOR
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