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

PHASE3CompletedINTERVENTIONAL
Enrollment

621

Participants

Timeline

Start Date

March 29, 2013

Primary Completion Date

September 28, 2018

Study Completion Date

December 9, 2019

Conditions
HER2+ Metastatic Breast Cancer (MBC)
Interventions
DRUG

neratinib

DRUG

capecitabine

DRUG

lapatinib

Trial Locations (252)

112

Taipei Veterans General Hospital, Taipei

1000

Institut Jules Bordet - Medical Oncology, Brussels

1200

University Hospital Saint-Luc, Brussels

2485

The Tweed Hospital, Tweed Heads

2610

Saint-Augustinus Hospital, Wilrijk

3000

Leuven University Hospitals, Leuven

3128

Box Hill Hospital, Oncology Department, Melbourne

3135

Maroondah Hospital, Maroondah Breast Clinic, Melbourne

4000

Clinic Saint-Joseph, Liège

4575

Sunshine Coast University Hospital, Birtinya

4700

Sjaelland University Hospital, Næstved

6020

University Hospital Innsbruck - Tyrolean Hospital, Department of Gynecology, Innsbruck

8038

Onkozentrum Zurich - Kinik im Park, Zurich

8401

Canton Hospital Winterthur, Winterthur

8833

Sydney Adventist Hospital, Wahroonga

10002

National Taiwan University Hospital, Taipei

10021

Clinical Research Alliance, Inc., New York

10060

Institute of Cancer Research and Treatment, Torino

10065

Weill Cornell Medical College, New York

10449

Mackay Memorial Hospital, Taipei

11042

Clinical Research Alliance, Lake Success

NYU Langone Medical Center, Lake Success

11733

North Shore Hematology Oncology Association PC, East Setauket

12002

Consorcio Hospitalario Provincial de Castellon, Castellon

13100

Ziv Medical Center, Safed

15122

UPMC Cancer Pavillion, West Mifflin

15146

UPMC Cancer Pavillion, Monroeville

15213

Magee Women's Hospital, Pittsburgh

15215

UPMC Cancer Pavillion, Pittsburgh

15232

Hillman Cancer Center, Pittsburgh

15237

UPMC Cancer Pavillion, Pittsburgh

15401

UPMC Cancer Pavillion, Uniontown

15601

UPMC Cancer Pavillion, Greensburg

17007

Hospital Universitari de Girona Dr. Josep Trueta (ICO Girona), Servicio de Oncologia, Girona

17033

Hershey Medical Center, Hershey

20016

Sibley Memorial Hospital, Washington D.C.

20132

IRCCS - Hospital San Raffaele, Department of Medical Oncology, Milan

20141

European Institute of Oncology, Milan

20871

Hospital Desio and Vimercate, Department of Medical Oncology, Vimercate

20900

Azienda Ospedaliero San Gerardo, Monza

21093

Sidney Kimmel Comprehensive Cancer Center at John Hopkins at Greenspring Station, Lutherville

21204

The Cancer Institute at University of Maryland St. Joseph Medical Center, Towson

21231

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Baltimore

23142

Taipei Tzu Chi General Hospital, New Taipei City

24105

University Hospital Schleswig-Holstein, Kiel

24127

Hospital Papa Giovanni XXIII, Department of Medical Oncology, Bergamo

University G. D'Annunzio Chieti Pescara, Chieti

28033

Centro Oncologico MD Anderson, Madrid

28040

University Hospital Clinic San Carlos, Servicio de Oncologia Medica, Madrid

28041

University Hospital 12 de Octubre, Servicio de Oncologia - Edificio Maternidad, 2ª planta, Madrid

28050

Centro Integral Oncologico Clara Campal, Madrid

28223

University Hospital Quiron Madrid, Department of Oncology, Madrid

30120

Hospital Universitario Virgen de la Arrixaca, Servicio de Oncologia, Murcia

30308

Emory University Hospital Midtown, Atlanta

30322

Emory Clinic, Atlanta

Emory University Winship Cancer Institute, Atlanta

33313

Broward Medical Oncology Office, Plantation

33324

Florida Cancer Research Institute, Plantation

33604

Practice for Oncology Bielefeld, Bielefeld

34890

Marmara University Faculty of Medicine, Istanbul

35016

Complejo Hospitalario Universitario Insular-Materno Infantil, Las Palmas de Gran Canaria

35100

Ege University, Bornova

37024

Hospital Sacro Cuore Don Calabria, Department of Medical Oncology, Negrar

38120

West Clinic PC, Memphis

38138

West Clinic PC, Germantown

40705

Taichung Veterans General Hospital, Breast Center, Taichung

41009

Hospital Universitario Virgen Macarena, Seville

41013

University Hospital Virgen del Rocio, Servicio de Oncologia, Seville

43303

Kuang Tien General Hospital, Taichung

44106

University Hospitals Cleveland Medical Center, Cleveland

44122

University Hospitals Case Medical Center, Orange

44195

Cleveland Clinic Taussig Cancer Center, Cleveland

44281

Meir Medical Center, Kfar Saba

46010

Hospital Clinico Universitario de Valencia, Servicio de Oncologia, Valencia

46321

Community Hospital, Munster

46342

Primary Health Oncology, Hobart

St. Mary Medical Center, Hobart

47014

Scientific Institute of Romagna of the Study and Treatment of Cancer, Meldola

47841

Hospital Cervesi di Cattolica, Department of Oncology, Cattolica

47900

Hospital Infermi Rimini, Unit of Oncology, Rimini

48201

Karmanos Cancer Institute, Detroit

49100

Rabin Medical Center, Belinson Hospital, Petah Tikva

50009

Hospital Clinico Universitario Lozano Blesa, Servicio de Oncologia, Zaragoza

50931

University Hospital Cologne, Breast Center, Clinic of Obstetrics and Gynecology, Cologne

52621

Chaim Sheba Medical Center, Tel Litwinsky

60014

North Shore Oncology-Hematology Associates, Ltd., Crystal Lake

60035

North Shore Hematology Oncology, Highland Park

60048

North Shore Oncology-Hematology Associates, Ltd., Libertyville

60057

Resurrection Medical Group, Chicago

60077

Orchard Healthcare Research Inc, Skokie

60426

Primary Healthcare Associates, SC, Harvey

63011

Center Jean Perrin, Clermont-Ferrand

63110

Washington University in St. Louis, St Louis

63129

Siteman Cancer Center - South County, St Louis

63141

Siteman Cancer Center - West County, St Louis

63376

Siteman Cancer Center - St. Peters, City of Saint Peters

64239

Sourasky Medical Center, Department of Oncology, Tel Aviv

67000

Clinic Sainte Anne, Center for Radiotherapy, Strasbourg

69495

South Lyon Hospital Center, Department of Clinical Hematology and Medical Oncology, Pierre-Bénite

70403

National Cheng Kung University Hospital, Tainan City

71004

Chi Mei Medical Center - YK Branch, Tainan City

74101

Hospital Novy Jicin, Nový Jičín

75010

Saint-Louis Hospital, Paris

75235

University of Texas Southwestern Medical Center at Dallas, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

80131

"National Cancer Institute - IRCCS Fondazione G. Pascale", Naples

83301

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

85100

Azienda Ospedaliera Regionale San Carlo, Potenza

85202

Ironwood Cancer and Research Centers, Scottsdale

85206

Ironwood Cancer and Research Centers, Mesa

85224

Ironwood Cancer and Research Centers, Chandler

86150

Hematology-Oncology Practice, Augsburg

88212

Onkologie Ravensburg, Ravensburg

89075

University Hospital Ulm, Ulm

89100

Hospital Bianchi Melacrino Morelli, Reggio Calabria

90277

Cancer Care Associates Medical Group, Inc, Redondo Beach

90404

UCLA Hematology Oncology, Santa Monica

91005

UCLA Hematology Oncology, Pasadena

91031

Shaare Zedek Medical Center, Jerusalem

91120

Hadassah Medical Center, Jerusalem

91326

UCLA Hematology Oncology, Porter Ranch

91355

UCLA Healthcare Santa Clarita Oncology, Valencia

91361

UCLA Hematology/Oncology, Westlake Village

91801

UCLA Hematology Oncology, Alhambra

92037

University of California San Diego Medical Center, La Jolla

92103

University of California San Diego Medical Center - Hillcrest, San Diego

92123

Sharp Memorial Hospital, San Diego

92373

Emad Ibrahim, MD, Redlands

92501

Compassionate Cancer Care Medical Group, Riverside

92604

UCLA Hematology Oncology, Irvine

92705

Breastlink Medical Group, Inc., Santa Ana

92708

Compassionate Cancer Care Medical Group Inc., Fountain Valley

92834

St. Jude Heritage Medical Group, Fullerton

92835

St. Jude Heritage Medical Group, Fullerton

92868

Breastlink Medical Group, Inc., Orange

93105

Cancer Center of Santa Barbara Sansum Clinic, Santa Barbara

93309

CBCC Global Research, Inc. at Comprehensive Blood and Caner Center, Bakersfield

93454

Central Coast Medical Oncology, Santa Maria

93463

Cancer Center of Santa Barbara, Solvang

94805

Gustave Roussy Oncology Institute, Department of Medicine, Villejuif

94904

Marin Cancer Care, Inc., Greenbrae

95297

Ironwood Cancer and Research Centers, Gilbert

96813

OnCare Hawaii, Honolulu

Queen's Medical Center, Honolulu

Straub Clinic and Hospital, Honolulu

University of Hawaii Cancer Center, Honolulu

97002

Buddhist Tzu-Chi General Hospital, Hualien City

115478

Russian Oncological Research Center n.a. N.N. Blokhin Russian Academy of Medical Sciences, Moscow

119228

National University Hospital, Singapore

129301

Federal State Government-Financed Institution: City Clinical Hospital #40, Moscow

169610

National Cancer Centre Singapore, Department of Medical Oncology, Singapore

188770

Raffles Hospital, Singapore

217562

Icon Singapore Oncology Consultants Farrer Park Medical Clinic, Singapore

258500

Gleneagles Medical Centre, Center for Medical Oncology, Singapore

Parkway Cancer Centre, Singapore

308433

Johns Hopkins Singapore International Medical Center, Singapore

392013

Tambov Regional Oncological Center, Tambov

2591193

Tokai University Hospital, Isehara

5418567

Osaka International Cancer Institute, Osaka

92093-0698

University of California San Diego Moores Cancer Center, La Jolla

02114

Massachusetts General Hospital, Boston

02215

Dana Farber Cancer Institute, Boston

08901

Cancer Institute of New Jersey, New Brunswick

B1880BBF

COIBA Centro de Oncología e Investigación Buenos Aires, Berazategui

C1025ABI

Fundación Investigar, Buenos Aires

NSW 2200

Bankstown-Lidcombe Hospital, Bankstown

NSW 2217

St. George Hospital, Kogarah

Unknown

Our Dear Lady Hospital, Aalst Campus, Aalst

AZ Damiaan General Hospital, Sint-Jozef Oncology Center, Ostend

Masaryk Memorial Cancer Institute, Brno

Prince of Wales Hospital, Shatin

Queen Elizabeth Hospital, Department of Clinical Oncology, Hong Kong

Queen Mary Hospital, Department of Clinical Oncology, Hong Kong

Queen Mary Hospital, Department of Oncology, Hong Kong

Queen Mary Hospital, Department of Surgery, Hong Kong

Tuen Mun Hospital, Hong Kong

St. Jame's Hospital, Dublin

St. Vincent's University Hospital, Dublin

Soroka Medical Center, Beersheba

Rambam Medical Center, Haifa

Kaplan Medical Center, Department of Oncology, Rehovot

National Cancer Center, Gyeonggi-do

Asan Medical Center, Seoul

Orebro University Hospital, Department of Oncology, Örebro

Uppsala University Hospital, Department of Oncology, Uppsala

Chi Mei Medical Center - LiouYing Branch, Tainan City

Tri-Service General Hospital, Taipei

Changhua Christian Hospital, Changhua

Chung-Ho Memorial Hospital, Kaohsiung City

Kaohsiung Veterans General Hospital, Kaohsiung City

B-2650

Antwerp University Hospital, Edegem

B-5000

St. Elizabeth Maternity Clinic, Namur

60336-045

Centro Regional Integrado de Oncologia, Fortaleza

40170-110

Núcleo de Oncologia da Bahia - NOB, Salvador

41950-610

Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética, Salvador

74605-070

Hospital Araújo Jorge, Associação de Combate ao Câncer em Goiás, Goiânia

81520-060

Liga Paranaense de Combate ao Cancer, Hospital Erasto Gaertner, Curitiba

95070-560

Instituto de Pesquisas Clinicas para Estudos Multicentricos Hospital Geral de Caxias do Sul, Universidade de Caxias do Sul (IPCEM), Caxias do Sul

90610-000

Hospital Sao Lucas da PUCRS, Porto Alegre

89201-260

Instituto Joinvillense de Hematologia e Oncologia, Joinville

14784-400

Hospital de Cancer de Barretos - Hospital, Barretos

14015-130

Instituto Ribeiraopretano de Combate Ao Cancer - Clinic/Outpatient Facility, Ribeirão Preto

15090-000

Fundação Faculdade Regional de Medicina de São José do Rio Preto, Hospital de Base, São José do Rio Preto

01509-900

Hospital Do Cancer A C Camargo - Hospital, São Paulo

03102-002

Instituto Brasileiro de Controle Do Câncer IBCC, São Paulo

T2N 4N2

Tom Baker Cancer Centre, Calgary

V2S 0C2

Abbotsford Regional Hospital and Cancer Care Centre, Abbotsford

V1Y 5L3

British Columbia Cancer Agency, Kelowna

V3V 1Z2

Fraser Health Authority, Surrey

L4M 6M2

Royal Victoria Regional Health Centre, Barrie

N2G1G3

Grand River Hospital, Kitchener

K1H 8L6

Ottawa Hospital, Cancer Center, Ottawa

M4C 3E7

Toronto East General Hospital, Toronto

M4N 3M5

Sunnybrook Health Sciences Center, Odette Cancer Center, Toronto

M5B1W8

St. Michael's Hospital, Toronto

H2L 4M1

CHUM Notre Dame Hospital, Montreal

H3G 1A4

Montreal General Hospital, Montreal

G1S 4L8

Centre hospitalier affilié universitaire de Québec - Hôpital du Saint-Sacrement, Québec

150 06

University Hospital Motol, Comprehensive Oncology Center, Prague

00029

Helsinki University Central Hospital, Department of Oncology, Helsinki

D-39106

Otto von Guericke University of Magdeburg, Magdeburg

00128

University Hospital Campus Bio-Medico, Rome

00144

National Cancer Institute Regina Elena, Rome

260-8677

Chiba University Hospital, Chiba

650-0047

Kobe City Medical Center General Hospital, Kobe

305-8576

University of Tsukuba Hospital, Tsukuba

0208505

Iwate Medical University Hospital, Morioka

860-8556

Kumamoto University Hospital, Kumamoto

362-0806

Saitama Cancer Centre, Kitaadachi-gun

830-0013

JCHO Kurume General Hospital, Fukuoka

371-8511

Gunma University Hospital, Gunma

730-8518

Hiroshima City Hospital, Hiroshima

003-0804

National Hospital Organization Hokkaido Cancer Center, Hokkaido

892-0833

Hakuaikai Medical Corporation Sagara Hospital, Kagoshima

540-0006

National Hospital Organization Osaka National Hospital, Ôsaka

105-8470

Toramonon Hospital, Tokyo

6229 HX

Maastricht University Medical Centre (MUMC), Maastricht

1099-023

Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE, Lisbon

1500-650

Centro de Investigação Clinica, Hospital da Luz, Lisbon

4200-072

Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E., Porto

120-752

Severance Hospital, Seoul

08035

Hospital Universitario Vall d'Hebron, Barcelona

07010

Hospital Universitario Son Espases, Palma de Mallorca

07198

Hospital Son Llatzer, Servicio de Oncologia, Palma de Mallorca

CH-3012

Hospital Engeried, Bern

CH-1211

University Hospital of Geneva, Geneva

CO4 5JL

Colchester General Hospital, Colchester

B15 2TH

Queen Elizabeth Hospital Birmingham, Birmingham

CF14 2TL

Velindre Cancer Centre, Cardiff

HX3 0PW

Calderdale Royal Hospital, Macmillan Unit, Halifax

HD3 3EA

Huddersfield Royal Infirmary, Huddersfield

NG5 1PB

Nottingham City Hospital Campus, Department of Oncology, Nottingham

All Listed Sponsors
lead

Puma Biotechnology, Inc.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter