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)

May 18, 2021 updated by: Puma Biotechnology, Inc.

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)

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.

Study Overview

Status

Completed

Conditions

HER2+ Metastatic Breast Cancer (MBC)

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

621

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- Buenos Aires
  - Berazategui, Buenos Aires, Argentina, B1880BBF
    - COIBA Centro de Oncología e Investigación Buenos Aires
- Ciudad Autónoma De BuenosAires
  - Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C1025ABI
    - Fundación Investigar
Australia
- - Bankstown, Australia, NSW 2200
    - Bankstown-Lidcombe Hospital
  - Kogarah, Australia, NSW 2217
    - St. George Hospital
  - Melbourne, Australia, 3128
    - Box Hill Hospital, Oncology Department
  - Melbourne, Australia, 3135
    - Maroondah Hospital, Maroondah Breast Clinic
  - Wahroonga, Australia, 8833
    - Sydney Adventist Hospital
- New South Wales
  - Tweed Heads, New South Wales, Australia, 2485
    - The Tweed Hospital
- Queensland
  - Birtinya, Queensland, Australia, 4575
    - Sunshine Coast University Hospital
Austria
- - Innsbruck, Austria, 6020
    - University Hospital Innsbruck - Tyrolean Hospital, Department of Gynecology
Belgium
- - Aalst, Belgium
    - Our Dear Lady Hospital, Aalst Campus
  - Brussels, Belgium, 1200
    - University Hospital Saint-Luc
  - Brussels, Belgium, 1000
    - Institut Jules Bordet - Medical Oncology
  - Edegem, Belgium, B-2650
    - Antwerp University Hospital
  - Leuven, Belgium, 3000
    - Leuven University Hospitals
  - Liege, Belgium, 4000
    - Clinic Saint-Joseph
  - Namur, Belgium, B-5000
    - St. Elizabeth Maternity Clinic
  - Ostend, Belgium
    - AZ Damiaan General Hospital, Sint-Jozef Oncology Center
  - Wilrijk, Belgium, 2610
    - Saint-Augustinus Hospital
Brazil
- - São Paulo, Brazil, 01509-900
    - Hospital Do Cancer A C Camargo - Hospital
  - São Paulo, Brazil, 03102-002
    - Instituto Brasileiro de Controle do Cancer Ibcc
- Bahia
  - Salvador, Bahia, Brazil, 40170-110
    - Nucleo de Oncologia da Bahia - NOB
  - Salvador, Bahia, Brazil, 41950-610
    - Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética
- Ceara
  - Fortaleza, Ceara, Brazil, 60336-045
    - Centro Regional Integrado de Oncologia
- Goiás
  - Goiânia, Goiás, Brazil, 74605-070
    - Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
- Parana
  - Curitiba, Parana, Brazil, 81520-060
    - Liga Paranaense de Combate ao Cancer, Hospital Erasto Gaertner
- Rio Grande Do Sul
  - Caxias do Sul, Rio Grande Do Sul, Brazil, 95070-560
    - Instituto de Pesquisas Clinicas para Estudos Multicentricos Hospital Geral de Caxias do Sul, Universidade de Caxias do Sul (IPCEM)
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
    - Hospital Sao Lucas da PUCRS
- Santa Catarina
  - Joinville, Santa Catarina, Brazil, 89201-260
    - Instituto Joinvillense de Hematologia e Oncologia
- Sao Paulo
  - Barretos, Sao Paulo, Brazil, 14784-400
    - Hospital de Cancer de Barretos - Hospital
  - Ribeirao Preto, Sao Paulo, Brazil, 14015-130
    - Instituto Ribeiraopretano de Combate Ao Cancer - Clinic/Outpatient Facility
- São Paulo
  - São José Do Rio Preto, São Paulo, Brazil, 15090-000
    - Fundação Faculdade Regional de Medicina de São José do Rio Preto, Hospital de Base
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Centre
- British Columbia
  - Abbotsford, British Columbia, Canada, V2S 0C2
    - Abbotsford Regional Hospital and Cancer Care Centre
  - Kelowna, British Columbia, Canada, V1Y 5L3
    - British Columbia Cancer Agency
  - Surrey, British Columbia, Canada, V3V 1Z2
    - Fraser Health Authority
- Ontario
  - Barrie, Ontario, Canada, L4M 6M2
    - Royal Victoria Regional Health Centre
  - Kitchener, Ontario, Canada, N2G1G3
    - Grand River Hospital
  - Ottawa, Ontario, Canada, K1H 8L6
    - Ottawa Hospital, Cancer Center
  - Toronto, Ontario, Canada, M4C 3E7
    - Toronto East General Hospital
  - Toronto, Ontario, Canada, M5B1W8
    - St. Michael's Hospital
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook Health Sciences Center, Odette Cancer Center
- Quebec
  - Montreal, Quebec, Canada, H3G 1A4
    - Montreal General Hospital
  - Montreal, Quebec, Canada, H2L 4M1
    - CHUM Notre Dame Hospital
  - Québec City, Quebec, Canada, G1S 4L8
    - Centre hospitalier affilié universitaire de Québec - Hôpital du Saint-Sacrement
Czechia
- - Brno, Czechia
    - Masaryk Memorial Cancer Institute
  - Novy Jicin, Czechia, 74101
    - Hospital Novy Jicin
  - Prague, Czechia, 150 06
    - University Hospital Motol, Comprehensive Oncology Center
Denmark
- - Naestved, Denmark, 4700
    - Sjaelland University Hospital
Finland
- - Helsinki, Finland, 00029
    - Helsinki University Central Hospital, Department of Oncology
France
- - Clermont-Ferrand, France, 63011
    - Center Jean Perrin
  - Paris, France, 75010
    - Saint-Louis Hospital
  - Strasbourg, France, 67000
    - Clinic Sainte Anne, Center for Radiotherapy
  - Villejuif, France, 94805
    - Gustave Roussy Oncology Institute, Department of Medicine
- Lyon
  - Pierre-Benite, Lyon, France, 69495
    - South Lyon Hospital Center, Department of Clinical Hematology and Medical Oncology
Germany
- - Augsburg, Germany, 86150
    - Hematology-Oncology Practice
  - Bielefeld, Germany, 33604
    - Practice for Oncology Bielefeld
  - Cologne, Germany, 50931
    - University Hospital Cologne, Breast Center, Clinic of Obstetrics and Gynecology
  - Kiel, Germany, 24105
    - University Hospital Schleswig-Holstein
  - Magdeburg, Germany, D-39106
    - Otto von Guericke University of Magdeburg
  - Ravensburg, Germany, 88212
    - Onkologie Ravensburg
  - Ulm, Germany, 89075
    - University Hospital Ulm
Hong Kong
- - Hong Kong, Hong Kong
    - Tuen Mun Hospital
  - Hong Kong, 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
- New Territories
  - Shatin, New Territories, Hong Kong
    - Prince of Wales Hospital
Ireland
- - Dublin, Ireland
    - St. Vincent's University Hospital
  - Dublin, Ireland
    - St. Jame's Hospital
Israel
- - Beersheba, Israel
    - Soroka Medical Center
  - Haifa, Israel
    - Rambam Medical Center
  - Jerusalem, Israel, 91120
    - Hadassah Medical Center
  - Jerusalem, Israel, 91031
    - Shaare Zedek Medical Center
  - Kfar-Saba, Israel, 44281
    - Meir Medical Center
  - Petah Tikva, Israel, 49100
    - Rabin Medical Center, Belinson Hospital
  - Rehovot, Israel
    - Kaplan Medical Center, Department of Oncology
  - Tel Hashomer, Israel, 52621
    - Chaim Sheba Medical Center
  - Tel-Aviv, Israel, 64239
    - Sourasky Medical Center, Department of Oncology
  - Zefat, Israel, 13100
    - Ziv Medical Center
Italy
- - Bergamo, Italy, 24127
    - Hospital Papa Giovanni XXIII, Department of Medical Oncology
  - Cattolica, Italy, 47841
    - Hospital Cervesi di Cattolica, Department of Oncology
  - Chieti, Italy, 24127
    - University G. d'Annunzio Chieti Pescara
  - Meldola, Italy, 47014
    - Scientific Institute of Romagna of the Study and Treatment of Cancer
  - Milan, Italy, 20141
    - European Institute of Oncology
  - Milan, Italy, 20132
    - IRCCS - Hospital San Raffaele, Department of Medical Oncology
  - Monza, Italy, 20900
    - Azienda Ospedaliero San Gerardo
  - Naples, Italy, 80131
    - National Cancer Institute - IRCCS "Fondazione G. Pascale"
  - Negrar, Italy, 37024
    - Hospital Sacro Cuore Don Calabria, Department of Medical Oncology
  - Potenza, Italy, 85100
    - Azienda Ospedaliera Regionale San Carlo
  - Reggio Calabria, Italy, 89100
    - Hospital Bianchi Melacrino Morelli
  - Rimini, Italy, 47900
    - Hospital Infermi Rimini, Unit of Oncology
  - Rome, Italy, 00128
    - University Hospital Campus Bio-Medico
  - Rome, Italy, 00144
    - National Cancer Institute Regina Elena
  - Torino, Italy, 10060
    - Institute of Cancer Research and Treatment
  - Vimercate, Italy, 20871
    - Hospital Desio and Vimercate, Department of Medical Oncology
Japan
- - Fukuoka, Japan, 830-0013
    - JCHO Kurume General Hospital
  - Gunma, Japan, 371-8511
    - Gunma University Hospital
  - Hiroshima, Japan, 730-8518
    - Hiroshima City Hospital
  - Hokkaido, Japan, 003-0804
    - National Hospital Organization Hokkaido Cancer Center
  - Kagoshima-city, Japan, 892-0833
    - Hakuaikai Medical Corporation Sagara Hospital
  - Osaka, Japan, 5418567
    - Osaka International Cancer Institute
  - Tokyo, Japan, 105-8470
    - Toramonon Hospital
  - Ôsaka, Japan, 540-0006
    - National Hospital Organization Osaka National Hospital
- Chiba
  - Chiba-shi, Chiba, Japan, 260-8677
    - Chiba University Hospital
- Hyôgo
  - Kobe-City, Hyôgo, Japan, 650-0047
    - Kobe City Medical Center General Hospital
- Ibaraki
  - Tsukuba, Ibaraki, Japan, 305-8576
    - University of Tsukuba Hospital
- Iwate
  - Morioka, Iwate, Japan, 0208505
    - Iwate Medical University Hospital
- Kanagawa
  - Isehara, Kanagawa, Japan, 2591193
    - Tokai University Hospital
- Kumamoto
  - Kumamoto-shi, Kumamoto, Japan, 860-8556
    - Kumamoto University Hospital
- Saitama
  - Kitaadachi-gun, Saitama, Japan, 362-0806
    - Saitama Cancer Centre
Korea, Republic of
- - Gyeonggi-do, Korea, Republic of
    - National Cancer Center
  - Seoul, Korea, Republic of
    - Asan Medical Center
  - Seoul, Korea, Republic of, 120-752
    - Severance Hospital
Netherlands
- - Maastricht, Netherlands, 6229 HX
    - Maastricht University Medical Centre (MUMC)
Portugal
- - Lisboa, Portugal, 1500-650
    - Centro de Investigação Clinica, Hospital da Luz
  - Lisbon, Portugal, 1099-023
    - Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
  - Porto, Portugal, 4200-072
    - Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
Russian Federation
- - Moscow, Russian Federation, 115478
    - Russian Oncological Research Center n.a. N.N. Blokhin Russian Academy of Medical Sciences
  - Tambov, Russian Federation, 392013
    - Tambov Regional Oncological Center
- Moskva
  - Moscow, Moskva, Russian Federation, 129301
    - Federal State Government-Financed Institution: City Clinical Hospital #40
Singapore
- - Singapore, Singapore, 308433
    - Johns Hopkins Singapore International Medical Center
  - Singapore, Singapore, 188770
    - Raffles Hospital
  - Singapore, Singapore, 119228
    - National University Hospital
  - Singapore, Singapore, 169610
    - National Cancer Centre Singapore, Department of Medical Oncology
  - Singapore, Singapore, 217562
    - Icon Singapore Oncology Consultants Farrer Park Medical Clinic
  - Singapore, Singapore, 258500
    - Gleneagles Medical Centre, Center for Medical Oncology
  - Singapore, Singapore, 258500
    - Parkway Cancer Centre
Spain
- - Barcelona, Spain, 08035
    - Hospital Universitario Vall d'Hebron
  - Castellon de la Plana, Spain, 12002
    - Consorcio Hospitalario Provincial de Castellón
  - Girona, Spain, 17007
    - Hospital Universitari de Girona Dr. Josep Trueta (ICO Girona), Servicio de Oncologia
  - Las Palmas de Gran Canaria, Spain, 35016
    - Complejo hospitalario Universitario Insular-Materno Infantil
  - Madrid, Spain, 28050
    - Centro Integral Oncológico Clara Campal
  - Madrid, Spain, 28033
    - Centro Oncológico MD Anderson
  - Madrid, Spain, 28040
    - University Hospital Clinic San Carlos, Servicio de Oncologia Medica
  - Madrid, Spain, 28041
    - University Hospital 12 de Octubre, Servicio de Oncologia - Edificio Maternidad, 2ª planta
  - Madrid, Spain, 28223
    - University Hospital Quiron Madrid, Department of Oncology
  - Murcia, Spain, 30120
    - Hospital Universitario Virgen de la Arrixaca, Servicio de Oncologia
  - Palma de Mallorca, Spain, 07010
    - Hospital Universitario Son Espases
  - Palma de Mallorca, Spain, 07198
    - Hospital Son Llatzer, Servicio de Oncologia
  - Sevilla, Spain, 41009
    - Hospital Universitario Virgen Macarena
  - Sevilla, Spain, 41013
    - University Hospital Virgen del Rocio, Servicio de Oncologia
  - Valencia, Spain, 46010
    - Hospital Clinico Universitario de Valencia, Servicio de Oncologia
  - Zaragoza, Spain, 50009
    - Hospital Clinico Universitario Lozano Blesa, Servicio de Oncologia
Sweden
- - Orebro, Sweden
    - Örebro University Hospital, Department of Oncology
  - Uppsala, Sweden
    - Uppsala University Hospital, Department of Oncology
Switzerland
- - Bern, Switzerland, CH-3012
    - Hospital Engeried
  - Geneva, Switzerland, CH-1211
    - University Hospital of Geneva
  - Winterthur, Switzerland, 8401
    - Canton Hospital Winterthur
  - Zurich, Switzerland, 8038
    - Onkozentrum Zurich - Kinik im Park
Taiwan
- - New Taipei City, Taiwan, 23142
    - Taipei Tzu Chi General Hospital
  - Taichung, Taiwan, 43303
    - Kuang Tien General Hospital
  - Taipei, Taiwan, 10002
    - National Taiwan University Hospital
  - Taipei, Taiwan, 112
    - Taipei Veterans General Hospital
- Province Of China
  - Kaohsiung, Province Of China, Taiwan, 83301
    - Kaohsiung Chang Gung Memorial Hospital
  - Taichung, Province Of China, Taiwan, 40705
    - Taichung Veterans General Hospital, Breast Center
  - Tainan, Province Of China, Taiwan, 70403
    - National Cheng Kung University Hospital
  - Tainan, Province Of China, Taiwan, 71004
    - Chi Mei Medical Center - YK Branch
  - Tainan, Province Of China, Taiwan
    - Chi Mei Medical Center - LiouYing Branch
  - Taipei, Province Of China, Taiwan, 10449
    - Mackay Memorial Hospital
  - Taipei, Province Of China, Taiwan
    - Tri-Service General Hospital
- Taiwan, Province Of China
  - Changhua, Taiwan, Province Of China, Taiwan
    - Changhua Christian Hospital
  - Hualien, Taiwan, Province Of China, Taiwan, 97002
    - Buddhist Tzu-Chi General Hospital
  - Kaohsiung, Taiwan, Province Of China, Taiwan
    - Chung-Ho Memorial Hospital
  - Kaohsiung, Taiwan, Province Of China, Taiwan
    - Kaohsiung Veterans General Hospital
Turkey
- - Istanbul, Turkey, 34890
    - Marmara University Faculty of Medicine
- Izmir
  - Bornova, Izmir, Turkey, 35100
    - Ege University
United Kingdom
- - Cardiff, United Kingdom, CF14 2TL
    - Velindre Cancer Centre
  - Halifax, United Kingdom, HX3 0PW
    - Calderdale Royal Hospital, Macmillan Unit
  - Huddersfield, United Kingdom, HD3 3EA
    - Huddersfield Royal Infirmary
  - Nottingham, United Kingdom, NG5 1PB
    - Nottingham City Hospital Campus, Department of Oncology
- Essex
  - Colchester, Essex, United Kingdom, CO4 5JL
    - Colchester General Hospital
- West Midlands
  - Birmingham, West Midlands, United Kingdom, B15 2TH
    - Queen Elizabeth Hospital Birmingham
United States
- Arizona
  - 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
    - Ironwood Cancer and Research Centers
- California
  - Alhambra, California, United States, 91801
    - UCLA Hematology Oncology
  - Bakersfield, California, United States, 93309
    - CBCC Global Research, Inc. at Comprehensive Blood and Caner Center
  - Fountain Valley, California, United States, 92708
    - Compassionate Cancer Care Medical Group Inc.
  - Fullerton, California, United States, 92835
    - St. Jude Heritage Medical Group
  - Fullerton, California, United States, 92834
    - St. Jude Heritage Medical Group
  - Greenbrae, California, United States, 94904
    - Marin Cancer Care, Inc.
  - Irvine, California, United States, 92604
    - UCLA Hematology Oncology
  - La Jolla, California, United States, 92037
    - University of California San Diego Medical Center
  - La Jolla, California, United States, 92093-0698
    - University of California San Diego Moores Cancer Center
  - Orange, California, United States, 92868
    - Breastlink Medical Group, Inc.
  - Pasadena, California, United States, 91005
    - UCLA Hematology Oncology
  - Porter Ranch, California, United States, 91326
    - UCLA Hematology Oncology
  - Redlands, California, United States, 92373
    - Emad Ibrahim, MD
  - Redondo Beach, California, United States, 90277
    - Cancer Care Associates Medical Group, Inc
  - Riverside, California, United States, 92501
    - Compassionate Cancer Care Medical Group
  - San Diego, California, United States, 92123
    - Sharp Memorial Hospital
  - San Diego, California, United States, 92103
    - University of California San Diego Medical Center - Hillcrest
  - Santa Ana, California, United States, 92705
    - Breastlink Medical Group, Inc.
  - Santa Barbara, California, United States, 93105
    - Cancer Center of Santa Barbara Sansum Clinic
  - Santa Maria, California, United States, 93454
    - Central Coast Medical Oncology
  - Santa Monica, California, United States, 90404
    - UCLA Hematology Oncology
  - Solvang, California, United States, 93463
    - Cancer Center of Santa Barbara
  - Valencia, California, United States, 91355
    - UCLA Healthcare Santa Clarita Oncology
  - Westlake Village, California, United States, 91361
    - UCLA Hematology/Oncology
- District of Columbia
  - Washington, District of Columbia, United States, 20016
    - Sibley Memorial Hospital
- Florida
  - Plantation, Florida, United States, 33324
    - Florida Cancer Research Institute
  - Plantation, Florida, United States, 33313
    - Broward Medical Oncology Office
- Georgia
  - Atlanta, Georgia, United States, 30308
    - Emory University Hospital Midtown
  - Atlanta, Georgia, United States, 30322
    - Emory Clinic
  - Atlanta, Georgia, United States, 30322
    - Emory University Winship Cancer Institute
- 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 Cancer Center
  - Honolulu, Hawaii, United States, 96813
    - OnCare Hawaii
- Illinois
  - Chicago, Illinois, United States, 60057
    - Resurrection Medical Group
  - Crystal Lake, Illinois, United States, 60014
    - North Shore Oncology-Hematology Associates, Ltd.
  - Harvey, Illinois, United States, 60426
    - Primary Healthcare Associates, SC
  - Highland Park, Illinois, United States, 60035
    - North Shore Hematology Oncology
  - Libertyville, Illinois, United States, 60048
    - North Shore Oncology-Hematology Associates, Ltd.
  - Skokie, Illinois, United States, 60077
    - Orchard Healthcare Research Inc
- Indiana
  - Hobart, Indiana, United States, 46342
    - St. Mary Medical Center
  - Hobart, Indiana, United States, 46342
    - Primary Health Oncology
  - Munster, Indiana, United States, 46321
    - Community Hospital
- Maryland
  - Baltimore, Maryland, United States, 21231
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
  - Lutherville, Maryland, United States, 21093
    - Sidney Kimmel Comprehensive Cancer Center at John Hopkins at Greenspring Station
  - Towson, Maryland, United States, 21204
    - The Cancer Institute at University of Maryland St. Joseph Medical Center
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02215
    - Dana Farber Cancer Institute
- Michigan
  - Detroit, Michigan, United States, 48201
    - Karmanos Cancer Institute
- Missouri
  - Saint Louis, Missouri, United States, 63129
    - Siteman Cancer Center - South County
  - Saint Louis, Missouri, United States, 63110
    - Washington University in St. Louis
  - Saint Louis, Missouri, United States, 63141
    - Siteman Cancer Center - West County
  - Saint Peters, Missouri, United States, 63376
    - Siteman Cancer Center - St. Peters
- New Jersey
  - New Brunswick, New Jersey, United States, 08901
    - Cancer Institute of New Jersey
- New York
  - East Setauket, New York, United States, 11733
    - North Shore Hematology Oncology Association PC
  - Lake Success, New York, United States, 11042
    - Clinical Research Alliance
  - Lake Success, New York, United States, 11042
    - NYU Langone Medical Center
  - New York, New York, United States, 10065
    - Weill Cornell Medical College
  - New York, New York, United States, 10021
    - Clinical Research Alliance, Inc.
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, United States, 44106
    - University Hospitals Cleveland Medical Center
  - Orange Village, Ohio, United States, 44122
    - University Hospitals Case Medical Center
- Pennsylvania
  - Greensburg, Pennsylvania, United States, 15601
    - UPMC Cancer Pavillion
  - Hershey, Pennsylvania, United States, 17033
    - Hershey Medical Center
  - Monroeville, Pennsylvania, United States, 15146
    - UPMC Cancer Pavillion
  - Pittsburgh, Pennsylvania, United States, 15232
    - Hillman Cancer Center
  - Pittsburgh, Pennsylvania, United States, 15213
    - Magee Women's Hospital
  - Pittsburgh, Pennsylvania, United States, 15215
    - 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
    - UPMC Cancer Pavillion
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - West Clinic PC
  - Memphis, Tennessee, United States, 38120
    - West Clinic PC
- Texas
  - Dallas, Texas, United States, 75390
    - University of Texas Southwestern Medical Center
  - Dallas, Texas, United States, 75235
    - University of Texas Southwestern Medical Center at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

Number of Arms

Arms and Interventions

Participant Group / 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: capecitabine Other Names: Xeloda Drug: neratinib Other Names: Nerlynx
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 Names: Xeloda Drug: lapatinib Other Names: Tykerb Tyverb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Centrally Assessed Progression Free Survival Time Frame: From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut.	Progression Free Survival (PFS), Measured in Months, for Randomized Subjects of the Central Assessment. The time interval from the date of randomization until the first date on which recurrence, progression (per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1), or death due to any cause, is documented. For subjects without recurrence, progression or death, it is censored at the last valid tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 24 months.	From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut.
Overall Survival Time Frame: From randomization date to death, assessed up to 59 months.The result is based on primary analysis data cut.	Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 48 months.	From randomization date to death, assessed up to 59 months.The result is based on primary analysis data cut.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention for Symptomatic Metastatic Central Nervous System Disease Time Frame: 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.	Intervention for symptomatic metastatic central nervous system disease is defined as the time from randomization to the first start date of an intervention for symptomatic metastatic CNS disease. Subjects that do not have an intervention for symptomatic metastatic CNS and do not die will be censored at the last date known alive on or prior to the data cutoff. Deaths are treated as competing events. Percentage of participants with intervention for CNS, estimated by cumulative incidence methods. Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring.	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.
Objective Response Rate (ORR) - Central Assessment (ITT Population With Measurable Disease at Screening) Time Frame: 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.	Objective response rate is defined as the percentage of participants demonstrating an objective response during the study. Objective response includes confirmed complete responses (CR) and partial responses (PR) as defined in the RECIST criteria included in the study protocol. The ORR is for Central Assessment for subjects that had measurable disease at screening. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	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.
Clinical Benefit Rate (CBR) - Central Assessment (ITT Population With Measurable Disease at Screening) Time Frame: 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.	Clinical benefit rate is the percentage of participants who achieve overall tumor response (confirmed CR or PR) or stable disease (SD) lasting for at least 24 weeks from randomization. The CBR was for Central Assessment for subjects who had Measurable Disease at Screening.	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.
Duration of Response (DOR) - Central Assessment (Population That Had a Response With Measurable Disease at Screening) Time Frame: From start date of response after randomization to first PD, up to 33 months.The result is based on primary analysis data cut.	The Duration of Response (DOR) is for Central Assessment for the Population that Had a Response with Measurable Disease at Screening. Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per RECIST v1.1. This value is censored at the last valid tumor assessment if PD or death has not been documented.	From start date of response after randomization to first PD, up to 33 months.The result is based on primary analysis data cut.
Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) Time Frame: From first dose through last dose + 28 days, up to 41 months. The result is based on final data cut.	Adverse Events to be measured are Treatment-Emergent and Serious AEs that occurred on or after first dose of investigational product and up to 28 days after the last dose	From first dose through last dose + 28 days, up to 41 months. The result is based on final data cut.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puma Biotechnology, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 29, 2013

Primary Completion (ACTUAL)

September 28, 2018

Study Completion (ACTUAL)

December 9, 2019

Study Registration Dates

First Submitted

March 4, 2013

First Submitted That Met QC Criteria

March 7, 2013

First Posted (ESTIMATE)

March 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

PUMA-NER-1301
2012-004492-38 (EUDRACT_NUMBER)
UTN U1111-1161-1603 (OTHER: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

IPD Sharing Time Frame

Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.

IPD Sharing Access Criteria

Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.

Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
ICF
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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