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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01808573
Recruitment Status : Active, not recruiting
First Posted : March 11, 2013
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

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.

Condition or disease Intervention/treatment Phase
HER2+ Metastatic Breast Cancer (MBC) Drug: neratinib Drug: capecitabine Drug: lapatinib Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 621 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 29, 2013
Actual Primary Completion Date : September 28, 2018
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: neratinib plus capecitabine
neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
Drug: neratinib
Other Name: Nerlynx

Drug: capecitabine
Other Name: Xeloda

Active Comparator: lapatinib plus capecitabine
lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
Drug: capecitabine
Other Name: Xeloda

Drug: lapatinib
Other Names:
  • Tykerb
  • Tyverb




Primary Outcome Measures :
  1. Independently assessed Progression Free Survival [ Time Frame: Estimated 10 months ]
  2. Overall Survival [ Time Frame: Estimated 28 months ]

Secondary Outcome Measures :
  1. Investigator Assessed Progression Free Survival [ Time Frame: Estimated 10 months ]
  2. Objective Response Rate (ORR) [ Time Frame: Estimated 10 months ]
  3. Clinical Benefit Rate (CBR) [ Time Frame: 24 weeks ]
    CBR is defined as Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for ≥ 24 weeks.

  4. Duration of Response (DOR) [ Time Frame: Estimated 10 months ]
  5. Time to intervention for symptomatic metastatic central nervous system disease [ Time Frame: Estimated 10 months ]
  6. Safety (Adverse Events and Serious Adverse Events) [ Time Frame: From consent through 30 days following treatment completion (estimated 11 months) ]
  7. Health Outcomes Assessments [ Time Frame: Estimated 10 months ]
    Validated Quality of Life Questionnaires


Other Outcome Measures:
  1. Population pharmacokinetics [ Time Frame: 1 month following enrollment ]
    Variability of neratinib concentration when administered in combination with capecitabine among individuals in the target population.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808573


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Locations
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United States, Arizona
Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224
Ironwood Cancer and Research Centers
Gilbert, Arizona, United States, 95297
Ironwood Cancer and Research Centers
Mesa, Arizona, United States, 85206
Ironwood Cancer and Research Centers
Scottsdale, Arizona, United States, 85202
United States, California
UCLA Hematology Oncology
Alhambra, California, United States, 91801
Innovative Clinical Research Institute
Anaheim, California, United States, 92801
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
Innovative Clinical Research Institute
Downey, California, United States, 90241
Compassionate Cancer Care Medical Group Inc
Fountain Valley, California, United States, 92708
St. Jude Heritage Medical Group
Fullerton, California, United States, 92834
St. Jude Heritage Medical Group
Fullerton, California, United States, 92835
Innovative Clinical Research Institute
Glendale, California, United States, 91204
Marin Cancer Care Inc
Greenbrae, California, United States, 94904
UCLA Hematology Oncology
Irvine, California, United States, 92604
University of California San Diego Medical Center
La Jolla, California, United States, 92037
University of California San Diego
La Jolla, California, United States, 92093-0698
Innovative Clinical Research Institute
Long Beach, California, United States, 90805
Innovative Clinical Research Institute
Montebello, California, United States, 90640
Breastlink Medical Group
Orange, California, United States, 92868
UCLA Hematology Oncology
Pasadena, California, United States, 91005
UCLA Hematology Oncology
Porter Ranch, California, United States, 91326
Redlands Community Hospital
Redlands, California, United States, 92373
Cancer Care Associates Medical Group, Inc
Redondo Beach, California, United States, 90277
Compassionate Cancer Care Medical Group
Riverside, California, United States, 92501
University of California San Diego Medical Center
San Diego, California, United States, 92103
Sharp Memorial Hospital
San Diego, California, United States, 92123
Breastlink Medical Group, Inc.
Santa Ana, California, United States, 92705
Innovative Clinical Research Institute
Santa Ana, California, United States, 92705
Cancer Center of Santa Barbara
Santa Barbara, California, United States, 93105
Sansum Clinic
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology
Santa Maria, California, United States, 93454
UCLA Hematology Oncology
Santa Monica, California, United States, 90404
Cancer Center of Santa Barbara
Solvang, California, United States, 93463
City of Hope Medical Group
South Pasadena, California, United States, 91030
Innovative Clinical Research Institute
Torrance, California, United States, 90503
UCLA Healthcare Santa Clarita Oncology
Valencia, California, United States, 91355
UCLA Hematology/Oncology
Westlake Village, California, United States, 91361
East Valley Hematology and Oncology Medical Group
Whittier, California, United States, 90603
Innovative Clinical Research Institute
Whittier, California, United States, 90603
United States, Colorado
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80525
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Cancer Care and Hematology - Greeley
Greeley, Colorado, United States, 80631
Medical Clinic at Centerra PC
Loveland, Colorado, United States, 80538
United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
Florida Cancer Research Institute
Boca Raton, Florida, United States, 33428
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Memorial Cancer Institute
Pembroke Pines, Florida, United States, 33028
United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Emory Clinic
Atlanta, Georgia, United States, 30322
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Hawaii
OnCare Hawaii
Honolulu, Hawaii, United States, 96813
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Resurrection Medical Group
Chicago, Illinois, United States, 60057
North Shore Oncology-Hematology Associates, Ltd.
Crystal Lake, Illinois, United States, 60014
Primary Healthcare Associates, SC
Harvey, Illinois, United States, 60426
North Shore Hematology Oncology
Highland Park, Illinois, United States, 60035
North Shore Oncology-Hematology Associates, Ltd.
Libertyville, Illinois, United States, 60048
Orchard Healthcare Research Inc
Skokie, Illinois, United States, 60077
Primary Healthcare Associates, SC
Tinley Park, Illinois, United States, 60477
United States, Indiana
Primary Health Oncology
Hobart, Indiana, United States, 46342
St. Mary Medical Center
Hobart, Indiana, United States, 46342
Community Hospital
Munster, Indiana, United States, 46321
United States, Kentucky
Norton Cancer Institute - Pavilion
Louisville, Kentucky, United States, 40202
Norton Cancer Institute - Suburban
Louisville, Kentucky, United States, 40207
Norton Cancer Institute - Audubon
Louisville, Kentucky, United States, 40217
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
Sidney Kimmel Comprehensive Cancer Center at John Hopkins at Greenspring Station
Lutherville, Maryland, United States, 21093
The Cancer Institute at University of Maryland St. Joseph Medical Center
Towson, Maryland, United States, 21204
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Mississippi
Mississippi Baptist Medical Center
Jackson, Mississippi, United States, 39202
Jackson Oncology Associates
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center - South County
Saint Louis, Missouri, United States, 63129
Siteman Cancer Center - West County
Saint Louis, Missouri, United States, 63141
Siteman Cancer Center - St. Peters
Saint Peters, Missouri, United States, 63376
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
North Shore Hematology Oncology Association PC
East Setauket, New York, United States, 11733
Clinical Research Alliance, Inc.
Lake Success, New York, United States, 11042
NYU Langone Medical Center
Lake Success, New York, United States, 11042
Clinical Research Alliance, Inc.
New York, New York, United States, 10021
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
Mission Hospitals
Asheville, North Carolina, United States, 28806
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Taussig Cancer Center at Cleveland Clinic
Cleveland, Ohio, United States, 44195
University Hospitals Case Medical Center
Orange Village, Ohio, United States, 44122
United States, Pennsylvania
UPMC Cancer Pavillion
Greensburg, Pennsylvania, United States, 15601
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
UPMC Cancer Pavillion
Monroeville, Pennsylvania, United States, 15146
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, United States, 15215
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, United States, 15237
UPMC Cancer Pavillion
Uniontown, Pennsylvania, United States, 15401
UPMC Cancer Pavillion
West Mifflin, Pennsylvania, United States, 15122
United States, Tennessee
West Clinic PC
Germantown, Tennessee, United States, 38138
West Clinic PC
Memphis, Tennessee, United States, 38120
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Smith Clinic
Houston, Texas, United States, 77054
Argentina
COIBA Centro de Oncología e Investigación Buenos Aires
Berazategui, Buenos Aires, Argentina, B1880BBF
Fundación Investigar
Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C1025ABI
Australia, Queensland
Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575
Australia
Bankstown-Lidcombe Hospital
Bankstown, Australia, NSW 2200
St. George Hospital, Clinical Research Unit, Division of Cancer Services
Kogarah, Australia, NSW 2217
Box Hill Hospital, Oncology Department
Melbourne, Australia, 3128
Maroondah Hospital, Maroondah Breast Clinic
Melbourne, Australia, 3135
Tweed Hospital, Cancer Care Centre
Tweed Heads, Australia
Sydney Adventist Hospital
Wahroonga, Australia, 8833
Austria
University Hospital Innsbruck - Tyrolean Hospital, Department of Gynecology
Innsbruck, Austria, 6020
Hospital of the Sisters of Mercy Linz, Department of Internal Medicine I, Medical Oncology, Hematology and Gastroenterology
Linz, Austria, 4010
Belgium
Our Dear Lady Hospital, Aalst Campus
Aalst, Belgium
Institut Jules Bordet - Medical Oncology
Brussels, Belgium, 1000
Saint Luc University Hospital
Brussels, Belgium, 1200
Antwerp University Hospital
Edegem, Belgium, B-2650
Leuven University Hospitals
Leuven, Belgium, 3000
Clinic Saint-Joseph
Liege, Belgium, 4000
St. Elizabeth Maternity Clinic
Namur, Belgium, B-5000
AZ Damiaan General Hospital, Sint-Jozef Oncology Center
Ostend, Belgium
St. Augustinus Hospital
Wilrijk, Belgium, 2610
Brazil
Núcleo de Oncologia da Bahia - NOB
Salvador, Bahia, Brazil, 40170-110
Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética
Salvador, Bahia, Brazil, 41950-610
Centro Regional Integrado de Oncologia
Fortaleza, Ceara, Brazil, 60336-045
Hospital Araújo Jorge, Associação de Combate ao Câncer em Goiás
Goiânia, Goiás, Brazil, 74605-070
Liga Paranaense de Combate ao Cancer, Hospital Erasto Gaertner
Curitiba, Parana, Brazil, 81520-060
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, 95070-560
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Instituto Joinvillense de Hematologia e Oncologia
Joinville, Santa Catarina, Brazil, 89201-260
Hospital de Cancer de Barretos - Hospital
Barretos, Sao Paulo, Brazil, 14784-400
Instituto Ribeiraopretano de Combate Ao Cancer - Clinic/Outpatient Facility
Ribeirao Preto, Sao Paulo, Brazil, 14015-130
Fundação Faculdade Regional de Medicina de São José do Rio Preto, Hospital de Base
São José Do Rio Preto, São Paulo, Brazil, 15090-000
Hospital Do Cancer A C Camargo - Hospital
Sao Paulo, Brazil, 01509-900
Instituto Brasileiro de Controle Do Câncer IBCC
São Paulo, Brazil, 03102-002
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
Abbotsford Cancer Centre
Abbotsford, British Columbia, Canada, V2S 0C2
British Columbia Cancer Agency
Kelowna, British Columbia, Canada, V1Y 5L3
Fraser Health Authority
Surrey, British Columbia, Canada, V3V 1Z2
Canada, Ontario
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M 6M2
Grand River Cancer Care Centre
Kitchener, Ontario, Canada, N2G1G3
Ottawa Hospital, Cancer Center
Ottawa, Ontario, Canada, K1H 8L6
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Sunnybrook Health Sciences Center, Odette Cancer Center
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Canada, Quebec
CHUM Notre Dame Hospital
Montreal, Quebec, Canada, H2L 4M1
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Centre hospitalier affilié universitaire de Québec - Hôpital du Saint-Sacrement
Québec City, Quebec, Canada, G1S 4L8
Czechia
Masaryk Memorial Cancer Institute
Brno, Czechia
Hospital Novy Jicin
Novy Jicin, Czechia, 741 01
University Hospital Motol, Comprehensive Oncology Center
Prague, Czechia, 150 06
Denmark
Sjaelland University Hospital
Naestved, Denmark, 4700
Finland
Helsinki University Central Hospital, Department of Oncology
Helsinki, Finland, 00029
France
South Lyon Hospital Center, Department of Clinical Hematology and Medical Oncology
Pierre-Benite, Lyon, France, 69495
Center Jean Perrin
Clermont-Ferrand, France, 63011
Saint-Louis Hospital
Paris, France, 75010
Clinic Sainte Anne, Center for Radiotherapy
Strasbourg, France, 67000
Gustave Roussy Oncology Institute, Department of Medicine
Villejuif, France, 94805
Germany
Hematology-Oncology Practice
Augsburg, Germany, 86150
Practice for Oncology Bielefeld
Bielefeld, Germany, 33604
University Hospital Cologne, Breast Center, Clinic of Obstetrics and Gynecology
Cologne, Germany, 50931
University Hospital Schleswig-Holstein
Kiel, Germany, 24105
Otto von Guericke University of Magdeburg
Magdeburg, Germany, D-39106
Oncology Ravensburg
Ravensburg, Germany, 88212
University Hospital Ulm, Department of Gynecology and Obstetrics
Ulm, Germany, 89075
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
Ireland
St. Jame's Hospital
Dublin, Ireland
St. Vincent's University Hospital
Dublin, Ireland
Israel
Soroka University Medical Center, Department of Oncology
Beersheba, Israel
Rambam Medical Center
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Hadassah Medical Center
Jerusalem, Israel, 91120
Meir Medical Center
Kfar-Saba, Israel, 44281
Rabin Medical Center, Belinson Hospital
Petah Tikva, Israel, 49100
Kaplan Medical Center, Department of Oncology
Rehovot, Israel
Chaim Sheba Medical Center, Institute of Oncology
Tel Hashomer, Israel, 52621
Sourasky Medical Center, Department of Oncology
Tel-Aviv, Israel, 64239
Ziv Medical Center
Zefat, Israel, 13100
Italy
Hospital Papa Giovanni XXIII, Department of Medical Oncology
Bergamo, Italy, 24127
Hospital Cervesi di Cattolica, Department of Oncology
Cattolica, Italy, 47841
University G. D'Annunzio Chieti Pescara
Chieti, Italy, 24127
Scientific Institute of Romagna of the Study and Treatment of Cancer
Meldola, Italy, 47014
IRCCS - Hospital San Raffaele, Department of Medical Oncology
Milan, Italy, 20132
European Institute of Oncology
Milan, Italy, 20141
Hospital San Gerardo, Complex Structure of Medical Oncology
Monza, Italy, 20900
National Cancer Institute - IRCCS "Fondazione G. Pascale"
Naples, Italy, 80131
Hospital Sacro Cuore Don Calabria, Department of Medical Oncology
Negrar, Italy, 37024
Hospital Bianchi Melacrino Morelli
Reggio Calabria, Italy, 89100
Hospital Infermi Rimini, Unit of Oncology
Rimini, Italy, 47900
University Hospital Campus Bio-Medico
Rome, Italy, 00128
National Cancer Institute Regina Elena IRCCS, Department of Medical Oncology A
Rome, Italy, 00144
Institute of Cancer Research and Treatment
Torino, Italy, 10060
Hospital Desio and Vimercate, Department of Medical Oncology
Vimercate, Italy, 20871
Japan
Chiba University Hospital
Chiba-shi, Chiba, Japan, 260-8677
Kobe City Medical Center General Hospital
Kobe-City, Hyôgo, Japan, 650-0047
Tsukuba University Hospital
Tsukuba, Ibaraki, Japan, 305-8576
Kumamoto University Hospital
Kumamoto-shi, Kumamoto, Japan, 860-8556
Osaka Medical Center for Cancer and Cardiovascular Diseases
Higashinari-ku, Osaka, Japan, 5378511
Saitama Cancer Centre
Kitaadachi-gun, Saitama, Japan, 362-0806
JCHO Kurume General Hospital
Fukuoka, Japan, 830-0013
Gunma University Hospital
Gunma, Japan, 371-8511
Hiroshima City Hospital
Hiroshima, Japan, 730-8518
National Hospital Organization Hokkaido Cancer Center
Hokkaido, Japan, 003-0804
Iwate Medical University Hospital
Iwate, Japan, 020-8505
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima-city, Japan, 892-0833
Toramonon Hospital
Tokyo, Japan, 105-8470
National Hospital Organization Osaka National Hospital
Ôsaka, Japan, 540-0006
Korea, Republic of
National Cancer Center
Gyeonggi-do, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Asan Medical Center
Seoul, Korea, Republic of
Netherlands
Maastricht University Medical Centre (MUMC)
Maastricht, Netherlands, 6229 HX
Portugal
Centro de Investigação Clinica, Hospital da Luz
Lisboa, Portugal, 1500-650
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon, Portugal, 1099-023
Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.
Porto, Portugal, 4200-072
Russian Federation
Federal State Government-Financed Institution: City Clinical Hospital #40
Moscow, Moskva, Russian Federation, 129301
Russian Oncological Research Center n.a. N.N. Blokhin or (blokhin Russian Oncology Research Center, Surgery Department of Breast Tumors)
Moscow, Russian Federation, 115478
Tambov Regional Oncological Center
Tambov, Russian Federation, 392013
Singapore
National University Hospital
Singapore, Singapore, 119228
National Cancer Centre Singapore, Department of Medical Oncology
Singapore, Singapore, 169610
Raffles Hospital
Singapore, Singapore, 188770
Gleneagles Medical Centre, Center for Medical Oncology
Singapore, Singapore, 258500
Parkway Cancer Centre
Singapore, Singapore, 258500
Johns Hopkins Singapore International Medical Center
Singapore, Singapore, 308433
Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Consorcio Hospitalario Provincial de Castellon, Servicio de Oncologia
Castellon de la Plana, Spain, 12002
Hospital Universitari de Girona Dr. Josep Trueta (ICO Girona), Servicio de Oncologia
Girona, Spain, 17007
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, Spain, 35016
Centro Oncologico MD Anderson International España
Madrid, Spain, 28033
University Hospital Clinic San Carlos, Servicio de Oncologia Medica
Madrid, Spain, 28040
University Hospital 12 de Octubre, Servicio de Oncologia - Edificio Maternidad, 2ª planta
Madrid, Spain, 28041
Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050
University Hospital Quiron Madrid, Department of Oncology
Madrid, Spain, 28223
Hospital Universitario Virgen de la Arrixaca, Servicio de Oncologia
Murcia, Spain, 30120
Hospital Universitario Son Espases, Servicio de Oncologia
Palma de Mallorca, Spain, 07010
Hospital Son Llatzer, Servicio de Oncologia
Palma de Mallorca, Spain, 07198
Hospital Universitario Virgen Macarena, Servicio de Oncologia. Consultas Externas, planta sotano
Sevilla, Spain, 41009
University Hospital Virgen del Rocio, Servicio de Oncologia
Sevilla, Spain, 41013
Hospital Clinico Universitario de Valencia, Servicio de Oncologia
Valencia, Spain, 46010
Hospital Clinico Universitario Lozano Blesa, Servicio de Oncologia
Zaragoza, Spain, 50009
Sweden
Orebro University Hospital, Department of Oncology
Orebro, Sweden
Uppsala University Hospital, Department of Oncology
Uppsala, Sweden
Switzerland
Hospital Engeried
Bern, Switzerland, CH-3012
University Hospital of Geneva
Geneva, Switzerland, CH-1211
Canton Hospital Winterthur
Winterthur, Switzerland
Onkozentrum Zurich - Kinik im Park
Zurich, Switzerland, 8038
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Province Of China, Taiwan, 83301
Taichung Veterans General Hospital, Breast Center
Taichung, Province Of China, Taiwan, 40705
National Cheng Kung University Hospital
Tainan, Province Of China, Taiwan, 70403
Chi Mei Medical Center - YK Branch
Tainan, Province Of China, Taiwan, 71004
Chi Mei Medical Center - LiouYing Branch
Tainan, Province Of China, Taiwan
Mackay Memorial Hospital
Taipei, Province Of China, Taiwan, 10449
Tri-Service General Hospital
Taipei, Province Of China, Taiwan
Changhua Christian Hospital
Changhua, Taiwan, Province Of China, Taiwan
Hualien Tzu Chi Medical Center
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
Turkey
Ege University
Bornova, Izmir, Turkey, 35100
Marmara University Faculty of Medicine
Istanbul, Turkey, 34890
United Kingdom
Colchester General Hospital
Colchester, Essex, United Kingdom, CO4 5JL
Queen Elizabeth Hospital, Queen Elizabeth Medical Centre
Birmingham, West Midlands, United Kingdom, B15 2TH
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Calderdale Royal Hospital, Macmillan Unit
Halifax, United Kingdom, HX3 0PW
Huddersfield Royal Infirmary
Huddersfield, United Kingdom, HD3 3EA
Nottingham City Hospital Campus, Department of Oncology
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
Layout table for investigator information
Study Director: Clinical Development Senior Vice President Puma Biotechnology, Inc.

Layout table for additonal information
Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT01808573     History of Changes
Other Study ID Numbers: PUMA-NER-1301
2012-004492-38 ( EudraCT Number )
UTN U1111-1161-1603 ( Other Identifier: WHO )
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Puma Biotechnology, Inc.:
Neratinib
Nerlynx

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Lapatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors