Clinical trial NCT01808573: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HER2+ Metastatic Breast Cancer (MBC)
Keywords: Neratinib
Nerlynx
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-11
Enrollment: 621
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: Inclusion Criteria:

* Aged ≥18 years at signing of informed consent.
* Histologically confirmed MBC, current stage IV.
* Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+, with confirmatory fluorescence in situ hybridization (FISH) +.
* Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.

Exclusion Criteria:

* Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.

Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Primary outcomes:
measure: Centrally Assessed Progression Free Survival
timeFrame: From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut.
measure: Overall Survival
timeFrame: From randomization date to death, assessed up to 59 months.The result is based on primary analysis data cut.
Secondary outcomes:
measure: Intervention for Symptomatic Metastatic Central Nervous System Disease
timeFrame: From randomization date to first intervention for symptomatic metastatic CNS disease, assessed up to 59 months.The result is based on primary analysis data cut.
measure: Objective Response Rate (ORR) - Central Assessment (ITT Population With Measurable Disease at Screening)
timeFrame: From randomization date to first confirmed Complete or Partial Response, whichever came earlier, up to 42 months.The result is based on primary analysis data cut.
measure: Clinical Benefit Rate (CBR) - Central Assessment (ITT Population With Measurable Disease at Screening)
timeFrame: From randomization date to either first confirmed CR or PR or Stable Disease, whichever came earlier, up to 42 months.The result is based on primary analysis data cut.
measure: Duration of Response (DOR) - Central Assessment (Population That Had a Response With Measurable Disease at Screening)
timeFrame: From start date of response after randomization to first PD, up to 33 months.The result is based on primary analysis data cut.
measure: Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events)
timeFrame: From first dose through last dose + 28 days, up to 41 months. The result is based on final data cut.
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Centers
state: Arizona
city: Gilbert
country: United States
facility: Ironwood Cancer and Research Centers
state: Arizona
city: Mesa
country: United States
facility: Ironwood Cancer and Research Centers
state: Arizona
city: Scottsdale
country: United States
facility: Ironwood Cancer and Research Centers
state: Arizona
city: Alhambra
country: United States
facility: UCLA Hematology Oncology
state: California
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc. at Comprehensive Blood and Caner Center
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Medical Group Inc.
state: California
city: Fullerton
country: United States
facility: St. Jude Heritage Medical Group
state: California
city: Fullerton
country: United States
facility: St. Jude Heritage Medical Group
state: California
city: Greenbrae
country: United States
facility: Marin Cancer Care, Inc.
state: California
city: Irvine
country: United States
facility: UCLA Hematology Oncology
state: California
city: La Jolla
country: United States
facility: University of California San Diego Medical Center
state: California
city: La Jolla
country: United States
facility: University of California San Diego Moores Cancer Center
state: California
city: Orange
country: United States
facility: Breastlink Medical Group, Inc.
state: California
city: Pasadena
country: United States
facility: UCLA Hematology Oncology
state: California
city: Porter Ranch
country: United States
facility: UCLA Hematology Oncology
state: California
city: Redlands
country: United States
facility: Emad Ibrahim, MD
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Medical Group, Inc
state: California
city: Riverside
country: United States
facility: Compassionate Cancer Care Medical Group
state: California
city: San Diego
country: United States
facility: University of California San Diego Medical Center - Hillcrest
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Santa Ana
country: United States
facility: Breastlink Medical Group, Inc.
state: California
city: Santa Barbara
country: United States
facility: Cancer Center of Santa Barbara Sansum Clinic
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology Oncology
state: California
city: Solvang
country: United States
facility: Cancer Center of Santa Barbara
state: California
city: Valencia
country: United States
facility: UCLA Healthcare Santa Clarita Oncology
state: California
city: Westlake Village
country: United States
facility: UCLA Hematology/Oncology
state: California
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Plantation
country: United States
facility: Broward Medical Oncology Office
state: Florida
city: Plantation
country: United States
facility: Florida Cancer Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
city: Honolulu
country: United States
facility: OnCare Hawaii
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Straub Clinic and Hospital
state: Hawaii
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
city: Chicago
country: United States
facility: Resurrection Medical Group
state: Illinois
city: Crystal Lake
country: United States
facility: North Shore Oncology-Hematology Associates, Ltd.
state: Illinois
city: Harvey
country: United States
facility: Primary Healthcare Associates, SC
state: Illinois
city: Highland Park
country: United States
facility: North Shore Hematology Oncology
state: Illinois
city: Libertyville
country: United States
facility: North Shore Oncology-Hematology Associates, Ltd.
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc
state: Illinois
city: Hobart
country: United States
facility: Primary Health Oncology
state: Indiana
city: Hobart
country: United States
facility: St. Mary Medical Center
state: Indiana
city: Munster
country: United States
facility: Community Hospital
state: Indiana
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
state: Maryland
city: Lutherville
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at John Hopkins at Greenspring Station
state: Maryland
city: Towson
country: United States
facility: The Cancer Institute at University of Maryland St. Joseph Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Saint Louis
country: United States
facility: Siteman Cancer Center - South County
state: Missouri
city: Saint Louis
country: United States
facility: Siteman Cancer Center - West County
state: Missouri
city: Saint Peters
country: United States
facility: Siteman Cancer Center - St. Peters
state: Missouri
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Association PC
state: New York
city: Lake Success
country: United States
facility: Clinical Research Alliance
state: New York
city: Lake Success
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Clinical Research Alliance, Inc.
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Orange Village
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Greensburg
country: United States
facility: UPMC Cancer Pavillion
state: Pennsylvania
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Monroeville
country: United States
facility: UPMC Cancer Pavillion
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Women's Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Pavillion
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Hillman Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Pavillion
state: Pennsylvania
city: Uniontown
country: United States
facility: UPMC Cancer Pavillion
state: Pennsylvania
city: West Mifflin
country: United States
facility: UPMC Cancer Pavillion
state: Pennsylvania
city: Germantown
country: United States
facility: West Clinic PC
state: Tennessee
city: Memphis
country: United States
facility: West Clinic PC
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Berazategui
country: Argentina
facility: COIBA Centro de Oncología e Investigación Buenos Aires
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Fundación Investigar
state: Ciudad Autónoma De BuenosAires
city: Tweed Heads
country: Australia
facility: The Tweed Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Bankstown
country: Australia
facility: Bankstown-Lidcombe Hospital
city: Kogarah
country: Australia
facility: St. George Hospital
city: Melbourne
country: Australia
facility: Box Hill Hospital, Oncology Department
city: Melbourne
country: Australia
facility: Maroondah Hospital, Maroondah Breast Clinic
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
city: Innsbruck
country: Austria
facility: University Hospital Innsbruck - Tyrolean Hospital, Department of Gynecology
city: Aalst
country: Belgium
facility: Our Dear Lady Hospital, Aalst Campus
city: Brussels
country: Belgium
facility: Institut Jules Bordet - Medical Oncology
city: Brussels
country: Belgium
facility: University Hospital Saint-Luc
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Leuven
country: Belgium
facility: Leuven University Hospitals
city: Liege
country: Belgium
facility: Clinic Saint-Joseph
city: Namur
country: Belgium
facility: St. Elizabeth Maternity Clinic
city: Ostend
country: Belgium
facility: AZ Damiaan General Hospital, Sint-Jozef Oncology Center
city: Wilrijk
country: Belgium
facility: Saint-Augustinus Hospital
city: Salvador
country: Brazil
facility: Núcleo de Oncologia da Bahia - NOB
state: Bahia
city: Salvador
country: Brazil
facility: Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética
state: Bahia
city: Fortaleza
country: Brazil
facility: Centro Regional Integrado de Oncologia
state: Ceara
city: Goiânia
country: Brazil
facility: Hospital Araújo Jorge, Associação de Combate ao Câncer em Goiás
state: Goiás
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate ao Cancer, Hospital Erasto Gaertner
state: Parana
city: Caxias do Sul
country: Brazil
facility: Instituto de Pesquisas Clinicas para Estudos Multicentricos Hospital Geral de Caxias do Sul, Universidade de Caxias do Sul (IPCEM)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Instituto Joinvillense de Hematologia e Oncologia
state: Santa Catarina
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos - Hospital
state: Sao Paulo
city: Ribeirao Preto
country: Brazil
facility: Instituto Ribeiraopretano de Combate Ao Cancer - Clinic/Outpatient Facility
state: Sao Paulo
city: São José Do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto, Hospital de Base
state: São Paulo
city: São Paulo
country: Brazil
facility: Hospital Do Cancer A C Camargo - Hospital
city: São Paulo
country: Brazil
facility: Instituto Brasileiro de Controle Do Câncer IBCC
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Abbotsford
country: Canada
facility: Abbotsford Regional Hospital and Cancer Care Centre
state: British Columbia
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Surrey
country: Canada
facility: Fraser Health Authority
state: British Columbia
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital, Cancer Center
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center, Odette Cancer Center
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: CHUM Notre Dame Hospital
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Québec City
country: Canada
facility: Centre hospitalier affilié universitaire de Québec - Hôpital du Saint-Sacrement
state: Quebec
city: Brno
country: Czechia
facility: Masaryk Memorial Cancer Institute
city: Novy Jicin
country: Czechia
facility: Hospital Novy Jicin
city: Prague
country: Czechia
facility: University Hospital Motol, Comprehensive Oncology Center
city: Naestved
country: Denmark
facility: Sjaelland University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, Department of Oncology
city: Pierre-Benite
country: France
facility: South Lyon Hospital Center, Department of Clinical Hematology and Medical Oncology
state: Lyon
city: Clermont-Ferrand
country: France
facility: Center Jean Perrin
city: Paris
country: France
facility: Saint-Louis Hospital
city: Strasbourg
country: France
facility: Clinic Sainte Anne, Center for Radiotherapy
city: Villejuif
country: France
facility: Gustave Roussy Oncology Institute, Department of Medicine
city: Augsburg
country: Germany
facility: Hematology-Oncology Practice
city: Bielefeld
country: Germany
facility: Practice for Oncology Bielefeld
city: Cologne
country: Germany
facility: University Hospital Cologne, Breast Center, Clinic of Obstetrics and Gynecology
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
city: Magdeburg
country: Germany
facility: Otto von Guericke University of Magdeburg
city: Ravensburg
country: Germany
facility: Onkologie Ravensburg
city: Ulm
country: Germany
facility: University Hospital Ulm
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: New Territories
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital, Department of Clinical Oncology
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, Department of Clinical Oncology
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, Department of Oncology
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, Department of Surgery
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
city: Dublin
country: Ireland
facility: St. Jame's Hospital
city: Dublin
country: Ireland
facility: St. Vincent's University Hospital
city: Beersheba
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Belinson Hospital
city: Rehovot
country: Israel
facility: Kaplan Medical Center, Department of Oncology
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center, Department of Oncology
city: Zefat
country: Israel
facility: Ziv Medical Center
city: Bergamo
country: Italy
facility: Hospital Papa Giovanni XXIII, Department of Medical Oncology
city: Cattolica
country: Italy
facility: Hospital Cervesi di Cattolica, Department of Oncology
city: Chieti
country: Italy
facility: University G. D'Annunzio Chieti Pescara
city: Meldola
country: Italy
facility: Scientific Institute of Romagna of the Study and Treatment of Cancer
city: Milan
country: Italy
facility: IRCCS - Hospital San Raffaele, Department of Medical Oncology
city: Milan
country: Italy
facility: European Institute of Oncology
city: Monza
country: Italy
facility: Azienda Ospedaliero San Gerardo
city: Naples
country: Italy
facility: National Cancer Institute - IRCCS "Fondazione G. Pascale"
city: Negrar
country: Italy
facility: Hospital Sacro Cuore Don Calabria, Department of Medical Oncology
city: Potenza
country: Italy
facility: Azienda Ospedaliera Regionale San Carlo
city: Reggio Calabria
country: Italy
facility: Hospital Bianchi Melacrino Morelli
city: Rimini
country: Italy
facility: Hospital Infermi Rimini, Unit of Oncology
city: Rome
country: Italy
facility: University Hospital Campus Bio-Medico
city: Rome
country: Italy
facility: National Cancer Institute Regina Elena
city: Torino
country: Italy
facility: Institute of Cancer Research and Treatment
city: Vimercate
country: Italy
facility: Hospital Desio and Vimercate, Department of Medical Oncology
city: Chiba-shi
country: Japan
facility: Chiba University Hospital
state: Chiba
city: Kobe-City
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyôgo
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
state: Ibaraki
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital
state: Kumamoto
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Centre
state: Saitama
city: Fukuoka
country: Japan
facility: JCHO Kurume General Hospital
city: Gunma
country: Japan
facility: Gunma University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima City Hospital
city: Hokkaido
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
city: Kagoshima-city
country: Japan
facility: Hakuaikai Medical Corporation Sagara Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Tokyo
country: Japan
facility: Toramonon Hospital
city: Ôsaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre (MUMC)
city: Lisboa
country: Portugal
facility: Centro de Investigação Clinica, Hospital da Luz
city: Lisbon
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.
city: Moscow
country: Russian Federation
facility: Federal State Government-Financed Institution: City Clinical Hospital #40
state: Moskva
city: Moscow
country: Russian Federation
facility: Russian Oncological Research Center n.a. N.N. Blokhin Russian Academy of Medical Sciences
city: Tambov
country: Russian Federation
facility: Tambov Regional Oncological Center
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore, Department of Medical Oncology
city: Singapore
country: Singapore
facility: Raffles Hospital
city: Singapore
country: Singapore
facility: Icon Singapore Oncology Consultants Farrer Park Medical Clinic
city: Singapore
country: Singapore
facility: Gleneagles Medical Centre, Center for Medical Oncology
city: Singapore
country: Singapore
facility: Parkway Cancer Centre
city: Singapore
country: Singapore
facility: Johns Hopkins Singapore International Medical Center
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Castellon de la Plana
country: Spain
facility: Consorcio Hospitalario Provincial de Castellon
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta (ICO Girona), Servicio de Oncologia
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular-Materno Infantil
city: Madrid
country: Spain
facility: Centro Oncologico MD Anderson
city: Madrid
country: Spain
facility: University Hospital Clinic San Carlos, Servicio de Oncologia Medica
city: Madrid
country: Spain
facility: University Hospital 12 de Octubre, Servicio de Oncologia - Edificio Maternidad, 2ª planta
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: Madrid
country: Spain
facility: University Hospital Quiron Madrid, Department of Oncology
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca, Servicio de Oncologia
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer, Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: University Hospital Virgen del Rocio, Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia, Servicio de Oncologia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa, Servicio de Oncologia
city: Orebro
country: Sweden
facility: Orebro University Hospital, Department of Oncology
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, Department of Oncology
city: Bern
country: Switzerland
facility: Hospital Engeried
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
city: Winterthur
country: Switzerland
facility: Canton Hospital Winterthur
city: Zurich
country: Switzerland
facility: Onkozentrum Zurich - Kinik im Park
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
state: Province Of China
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital, Breast Center
state: Province Of China
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
state: Province Of China
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center - YK Branch
state: Province Of China
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center - LiouYing Branch
state: Province Of China
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
state: Province Of China
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
state: Province Of China
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
state: Taiwan, Province Of China
city: Hualien
country: Taiwan
facility: Buddhist Tzu-Chi General Hospital
state: Taiwan, Province Of China
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Memorial Hospital
state: Taiwan, Province Of China
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
state: Taiwan, Province Of China
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi General Hospital
city: Taichung
country: Taiwan
facility: Kuang Tien General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bornova
country: Turkey
facility: Ege University
state: Izmir
city: Istanbul
country: Turkey
facility: Marmara University Faculty of Medicine
city: Colchester
country: United Kingdom
facility: Colchester General Hospital
state: Essex
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
state: West Midlands
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: Halifax
country: United Kingdom
facility: Calderdale Royal Hospital, Macmillan Unit
city: Huddersfield
country: United Kingdom
facility: Huddersfield Royal Infirmary
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital Campus, Department of Oncology
Study officials:
affiliation: Puma Biotechnology, Inc.
name: Senior Vice President Clinical Science and Pharmacology
role: STUDY_DIRECTOR
References:
citation: Dai MS, Feng YH, Chen SW, Masuda N, Yau T, Chen ST, Lu YS, Yap YS, Ang PCS, Chu SC, Kwong A, Lee KS, Ow S, Kim SB, Lin J, Chung HC, Ngan R, Kok VC, Rau KM, Sangai T, Ng TY, Tseng LM, Bryce R, Bebchuk J, Chen MC, Hou MF. Analysis of the pan-Asian subgroup of patients in the NALA Trial: a randomized phase III NALA Trial comparing neratinib+capecitabine (N+C) vs lapatinib+capecitabine (L+C) in patients with HER2+metastatic breast cancer (mBC) previously treated with two or more HER2-directed regimens. Breast Cancer Res Treat. 2021 Oct;189(3):665-676. doi: 10.1007/s10549-021-06313-5. Epub 2021 Sep 23.
citation: Saura C, Oliveira M, Feng YH, Dai MS, Chen SW, Hurvitz SA, Kim SB, Moy B, Delaloge S, Gradishar W, Masuda N, Palacova M, Trudeau ME, Mattson J, Yap YS, Hou MF, De Laurentiis M, Yeh YM, Chang HT, Yau T, Wildiers H, Haley B, Fagnani D, Lu YS, Crown J, Lin J, Takahashi M, Takano T, Yamaguchi M, Fujii T, Yao B, Bebchuk J, Keyvanjah K, Bryce R, Brufsky A; NALA Investigators. Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer Previously Treated With >/= 2 HER2-Directed Regimens: Phase III NALA Trial. J Clin Oncol. 2020 Sep 20;38(27):3138-3149. doi: 10.1200/JCO.20.00147. Epub 2020 Jul 17.