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
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)
3 other identifiers
interventional
621
27 countries
245
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2013
Longer than P75 for phase_3
245 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2013
CompletedFirst Posted
Study publicly available on registry
March 11, 2013
CompletedStudy Start
First participant enrolled
March 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2019
CompletedResults Posted
Study results publicly available
December 11, 2019
CompletedJune 11, 2021
May 1, 2021
5.5 years
March 4, 2013
September 27, 2019
May 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Centrally Assessed Progression Free Survival
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
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 Outcomes (5)
Intervention for Symptomatic Metastatic Central Nervous System Disease
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)
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)
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)
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)
From first dose through last dose + 28 days, up to 41 months. The result is based on final data cut.
Study Arms (2)
neratinib plus capecitabine
EXPERIMENTALneratinib 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.
lapatinib plus capecitabine
ACTIVE COMPARATORlapatinib 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (252)
Ironwood Cancer and Research Centers
Chandler, Arizona, 85224, United States
Ironwood Cancer and Research Centers
Gilbert, Arizona, 95297, United States
Ironwood Cancer and Research Centers
Mesa, Arizona, 85206, United States
Ironwood Cancer and Research Centers
Scottsdale, Arizona, 85202, United States
UCLA Hematology Oncology
Alhambra, California, 91801, United States
CBCC Global Research, Inc. at Comprehensive Blood and Caner Center
Bakersfield, California, 93309, United States
Compassionate Cancer Care Medical Group Inc.
Fountain Valley, California, 92708, United States
St. Jude Heritage Medical Group
Fullerton, California, 92834, United States
St. Jude Heritage Medical Group
Fullerton, California, 92835, United States
Marin Cancer Care, Inc.
Greenbrae, California, 94904, United States
UCLA Hematology Oncology
Irvine, California, 92604, United States
University of California San Diego Medical Center
La Jolla, California, 92037, United States
University of California San Diego Moores Cancer Center
La Jolla, California, 92093-0698, United States
Breastlink Medical Group, Inc.
Orange, California, 92868, United States
UCLA Hematology Oncology
Pasadena, California, 91005, United States
UCLA Hematology Oncology
Porter Ranch, California, 91326, United States
Emad Ibrahim, MD
Redlands, California, 92373, United States
Cancer Care Associates Medical Group, Inc
Redondo Beach, California, 90277, United States
Compassionate Cancer Care Medical Group
Riverside, California, 92501, United States
University of California San Diego Medical Center - Hillcrest
San Diego, California, 92103, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Breastlink Medical Group, Inc.
Santa Ana, California, 92705, United States
Cancer Center of Santa Barbara Sansum Clinic
Santa Barbara, California, 93105, United States
Central Coast Medical Oncology
Santa Maria, California, 93454, United States
UCLA Hematology Oncology
Santa Monica, California, 90404, United States
Cancer Center of Santa Barbara
Solvang, California, 93463, United States
UCLA Healthcare Santa Clarita Oncology
Valencia, California, 91355, United States
UCLA Hematology/Oncology
Westlake Village, California, 91361, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Broward Medical Oncology Office
Plantation, Florida, 33313, United States
Florida Cancer Research Institute
Plantation, Florida, 33324, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory Clinic
Atlanta, Georgia, 30322, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322, United States
OnCare Hawaii
Honolulu, Hawaii, 96813, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Resurrection Medical Group
Chicago, Illinois, 60057, United States
North Shore Oncology-Hematology Associates, Ltd.
Crystal Lake, Illinois, 60014, United States
Primary Healthcare Associates, SC
Harvey, Illinois, 60426, United States
North Shore Hematology Oncology
Highland Park, Illinois, 60035, United States
North Shore Oncology-Hematology Associates, Ltd.
Libertyville, Illinois, 60048, United States
Orchard Healthcare Research Inc
Skokie, Illinois, 60077, United States
Primary Health Oncology
Hobart, Indiana, 46342, United States
St. Mary Medical Center
Hobart, Indiana, 46342, United States
Community Hospital
Munster, Indiana, 46321, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, 21231, United States
Sidney Kimmel Comprehensive Cancer Center at John Hopkins at Greenspring Station
Lutherville, Maryland, 21093, United States
The Cancer Institute at University of Maryland St. Joseph Medical Center
Towson, Maryland, 21204, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Siteman Cancer Center - St. Peters
City of Saint Peters, Missouri, 63376, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Siteman Cancer Center - South County
St Louis, Missouri, 63129, United States
Siteman Cancer Center - West County
St Louis, Missouri, 63141, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
North Shore Hematology Oncology Association PC
East Setauket, New York, 11733, United States
Clinical Research Alliance
Lake Success, New York, 11042, United States
NYU Langone Medical Center
Lake Success, New York, 11042, United States
Clinical Research Alliance, Inc.
New York, New York, 10021, United States
Weill Cornell Medical College
New York, New York, 10065, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
University Hospitals Case Medical Center
Orange, Ohio, 44122, United States
UPMC Cancer Pavillion
Greensburg, Pennsylvania, 15601, United States
Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
UPMC Cancer Pavillion
Monroeville, Pennsylvania, 15146, United States
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, 15215, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, 15237, United States
UPMC Cancer Pavillion
Uniontown, Pennsylvania, 15401, United States
UPMC Cancer Pavillion
West Mifflin, Pennsylvania, 15122, United States
West Clinic PC
Germantown, Tennessee, 38138, United States
West Clinic PC
Memphis, Tennessee, 38120, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
COIBA Centro de Oncología e Investigación Buenos Aires
Berazategui, Buenos Aires, B1880BBF, Argentina
Fundación Investigar
Buenos Aires, Ciudad Autónoma de BuenosAires, C1025ABI, Argentina
The Tweed Hospital
Tweed Heads, New South Wales, 2485, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Bankstown-Lidcombe Hospital
Bankstown, NSW 2200, Australia
St. George Hospital
Kogarah, NSW 2217, Australia
Box Hill Hospital, Oncology Department
Melbourne, 3128, Australia
Maroondah Hospital, Maroondah Breast Clinic
Melbourne, 3135, Australia
Sydney Adventist Hospital
Wahroonga, 8833, Australia
University Hospital Innsbruck - Tyrolean Hospital, Department of Gynecology
Innsbruck, 6020, Austria
Our Dear Lady Hospital, Aalst Campus
Aalst, Belgium
Institut Jules Bordet - Medical Oncology
Brussels, 1000, Belgium
University Hospital Saint-Luc
Brussels, 1200, Belgium
Antwerp University Hospital
Edegem, B-2650, Belgium
Leuven University Hospitals
Leuven, 3000, Belgium
Clinic Saint-Joseph
Liège, 4000, Belgium
St. Elizabeth Maternity Clinic
Namur, B-5000, Belgium
AZ Damiaan General Hospital, Sint-Jozef Oncology Center
Ostend, Belgium
Saint-Augustinus Hospital
Wilrijk, 2610, Belgium
Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336-045, Brazil
Núcleo de Oncologia da Bahia - NOB
Salvador, Estado de Bahia, 40170-110, Brazil
Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética
Salvador, Estado de Bahia, 41950-610, Brazil
Hospital Araújo Jorge, Associação de Combate ao Câncer em Goiás
Goiânia, Goiás, 74605-070, Brazil
Liga Paranaense de Combate ao Cancer, Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
Instituto de Pesquisas Clinicas para Estudos Multicentricos Hospital Geral de Caxias do Sul, Universidade de Caxias do Sul (IPCEM)
Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Instituto Joinvillense de Hematologia e Oncologia
Joinville, Santa Catarina, 89201-260, Brazil
Hospital de Cancer de Barretos - Hospital
Barretos, São Paulo, 14784-400, Brazil
Instituto Ribeiraopretano de Combate Ao Cancer - Clinic/Outpatient Facility
Ribeirão Preto, São Paulo, 14015-130, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto, Hospital de Base
São José do Rio Preto, São Paulo, 15090-000, Brazil
Hospital Do Cancer A C Camargo - Hospital
São Paulo, 01509-900, Brazil
Instituto Brasileiro de Controle Do Câncer IBCC
São Paulo, 03102-002, Brazil
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Abbotsford Regional Hospital and Cancer Care Centre
Abbotsford, British Columbia, V2S 0C2, Canada
British Columbia Cancer Agency
Kelowna, British Columbia, V1Y 5L3, Canada
Fraser Health Authority
Surrey, British Columbia, V3V 1Z2, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
Grand River Hospital
Kitchener, Ontario, N2G1G3, Canada
Ottawa Hospital, Cancer Center
Ottawa, Ontario, K1H 8L6, Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7, Canada
Sunnybrook Health Sciences Center, Odette Cancer Center
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B1W8, Canada
CHUM Notre Dame Hospital
Montreal, Quebec, H2L 4M1, Canada
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Centre hospitalier affilié universitaire de Québec - Hôpital du Saint-Sacrement
Québec, Quebec, G1S 4L8, Canada
Masaryk Memorial Cancer Institute
Brno, Czechia
Hospital Novy Jicin
Nový Jičín, 74101, Czechia
University Hospital Motol, Comprehensive Oncology Center
Prague, 150 06, Czechia
Sjaelland University Hospital
Næstved, 4700, Denmark
Helsinki University Central Hospital, Department of Oncology
Helsinki, 00029, Finland
South Lyon Hospital Center, Department of Clinical Hematology and Medical Oncology
Pierre-Bénite, Lyon, 69495, France
Center Jean Perrin
Clermont-Ferrand, 63011, France
Saint-Louis Hospital
Paris, 75010, France
Clinic Sainte Anne, Center for Radiotherapy
Strasbourg, 67000, France
Gustave Roussy Oncology Institute, Department of Medicine
Villejuif, 94805, France
Hematology-Oncology Practice
Augsburg, 86150, Germany
Practice for Oncology Bielefeld
Bielefeld, 33604, Germany
University Hospital Cologne, Breast Center, Clinic of Obstetrics and Gynecology
Cologne, 50931, Germany
University Hospital Schleswig-Holstein
Kiel, 24105, Germany
Otto von Guericke University of Magdeburg
Magdeburg, D-39106, Germany
Onkologie Ravensburg
Ravensburg, 88212, Germany
University Hospital Ulm
Ulm, 89075, Germany
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Queen Elizabeth Hospital, Department of Clinical Oncology
Hong Kong, Hong Kong
Queen Mary Hospital, Department of Clinical Oncology
Hong Kong, Hong Kong
Queen Mary Hospital, Department of Oncology
Hong Kong, Hong Kong
Queen Mary Hospital, Department of Surgery
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
St. Jame's Hospital
Dublin, Ireland
St. Vincent's University Hospital
Dublin, Ireland
Soroka Medical Center
Beersheba, Israel
Rambam Medical Center
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah Medical Center
Jerusalem, 91120, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center, Belinson Hospital
Petah Tikva, 49100, Israel
Kaplan Medical Center, Department of Oncology
Rehovot, Israel
Ziv Medical Center
Safed, 13100, Israel
Sourasky Medical Center, Department of Oncology
Tel Aviv, 64239, Israel
Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Hospital Papa Giovanni XXIII, Department of Medical Oncology
Bergamo, 24127, Italy
Hospital Cervesi di Cattolica, Department of Oncology
Cattolica, 47841, Italy
University G. D'Annunzio Chieti Pescara
Chieti, 24127, Italy
Scientific Institute of Romagna of the Study and Treatment of Cancer
Meldola, 47014, Italy
IRCCS - Hospital San Raffaele, Department of Medical Oncology
Milan, 20132, Italy
European Institute of Oncology
Milan, 20141, Italy
Azienda Ospedaliero San Gerardo
Monza, 20900, Italy
National Cancer Institute - IRCCS "Fondazione G. Pascale"
Naples, 80131, Italy
Hospital Sacro Cuore Don Calabria, Department of Medical Oncology
Negrar, 37024, Italy
Azienda Ospedaliera Regionale San Carlo
Potenza, 85100, Italy
Hospital Bianchi Melacrino Morelli
Reggio Calabria, 89100, Italy
Hospital Infermi Rimini, Unit of Oncology
Rimini, 47900, Italy
University Hospital Campus Bio-Medico
Rome, 00128, Italy
National Cancer Institute Regina Elena
Rome, 00144, Italy
Institute of Cancer Research and Treatment
Torino, 10060, Italy
Hospital Desio and Vimercate, Department of Medical Oncology
Vimercate, 20871, Italy
Chiba University Hospital
Chiba, Chiba, 260-8677, Japan
Kobe City Medical Center General Hospital
Kobe, Hyôgo, 650-0047, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576, Japan
Iwate Medical University Hospital
Morioka, Iwate, 0208505, Japan
Tokai University Hospital
Isehara, Kanagawa, 2591193, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556, Japan
Saitama Cancer Centre
Kitaadachi-gun, Saitama, 362-0806, Japan
JCHO Kurume General Hospital
Fukuoka, 830-0013, Japan
Gunma University Hospital
Gunma, 371-8511, Japan
Hiroshima City Hospital
Hiroshima, 730-8518, Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido, 003-0804, Japan
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima, 892-0833, Japan
Osaka International Cancer Institute
Osaka, 5418567, Japan
National Hospital Organization Osaka National Hospital
Ôsaka, 540-0006, Japan
Toramonon Hospital
Tokyo, 105-8470, Japan
Maastricht University Medical Centre (MUMC)
Maastricht, 6229 HX, Netherlands
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon, 1099-023, Portugal
Centro de Investigação Clinica, Hospital da Luz
Lisbon, 1500-650, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.
Porto, 4200-072, Portugal
Federal State Government-Financed Institution: City Clinical Hospital #40
Moscow, Moscow, 129301, Russia
Russian Oncological Research Center n.a. N.N. Blokhin Russian Academy of Medical Sciences
Moscow, 115478, Russia
Tambov Regional Oncological Center
Tambov, 392013, Russia
National University Hospital
Singapore, 119228, Singapore
National Cancer Centre Singapore, Department of Medical Oncology
Singapore, 169610, Singapore
Raffles Hospital
Singapore, 188770, Singapore
Icon Singapore Oncology Consultants Farrer Park Medical Clinic
Singapore, 217562, Singapore
Gleneagles Medical Centre, Center for Medical Oncology
Singapore, 258500, Singapore
Parkway Cancer Centre
Singapore, 258500, Singapore
Johns Hopkins Singapore International Medical Center
Singapore, 308433, Singapore
National Cancer Center
Gyeonggi-do, South Korea
Severance Hospital
Seoul, 120-752, South Korea
Asan Medical Center
Seoul, South Korea
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Consorcio Hospitalario Provincial de Castellon
Castellon, 12002, Spain
Hospital Universitari de Girona Dr. Josep Trueta (ICO Girona), Servicio de Oncologia
Girona, 17007, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, 35016, Spain
Centro Oncologico MD Anderson
Madrid, 28033, Spain
University Hospital Clinic San Carlos, Servicio de Oncologia Medica
Madrid, 28040, Spain
University Hospital 12 de Octubre, Servicio de Oncologia - Edificio Maternidad, 2ª planta
Madrid, 28041, Spain
Centro Integral Oncologico Clara Campal
Madrid, 28050, Spain
University Hospital Quiron Madrid, Department of Oncology
Madrid, 28223, Spain
Hospital Universitario Virgen de la Arrixaca, Servicio de Oncologia
Murcia, 30120, Spain
Hospital Universitario Son Espases
Palma de Mallorca, 07010, Spain
Hospital Son Llatzer, Servicio de Oncologia
Palma de Mallorca, 07198, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
University Hospital Virgen del Rocio, Servicio de Oncologia
Seville, 41013, Spain
Hospital Clinico Universitario de Valencia, Servicio de Oncologia
Valencia, 46010, Spain
Hospital Clinico Universitario Lozano Blesa, Servicio de Oncologia
Zaragoza, 50009, Spain
Orebro University Hospital, Department of Oncology
Örebro, Sweden
Uppsala University Hospital, Department of Oncology
Uppsala, Sweden
Hospital Engeried
Bern, CH-3012, Switzerland
University Hospital of Geneva
Geneva, CH-1211, Switzerland
Canton Hospital Winterthur
Winterthur, 8401, Switzerland
Onkozentrum Zurich - Kinik im Park
Zurich, 8038, Switzerland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Province of China, 83301, Taiwan
Taichung Veterans General Hospital, Breast Center
Taichung, Province of China, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, Province of China, 70403, Taiwan
Chi Mei Medical Center - YK Branch
Tainan, Province of China, 71004, Taiwan
Chi Mei Medical Center - LiouYing Branch
Tainan, Province of China, Taiwan
Mackay Memorial Hospital
Taipei, Province of China, 10449, Taiwan
Tri-Service General Hospital
Taipei, Province of China, Taiwan
Changhua Christian Hospital
Changhua, Taiwan, Province of China, Taiwan
Buddhist Tzu-Chi General Hospital
Hualien City, Taiwan, Province of China, 97002, Taiwan
Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, Province of China, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, Province of China, Taiwan
Taipei Tzu Chi General Hospital
New Taipei City, 23142, Taiwan
Kuang Tien General Hospital
Taichung, 43303, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Ege University
Bornova, İzmir, 35100, Turkey (Türkiye)
Marmara University Faculty of Medicine
Istanbul, 34890, Turkey (Türkiye)
Colchester General Hospital
Colchester, Essex, CO4 5JL, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2TH, United Kingdom
Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
Calderdale Royal Hospital, Macmillan Unit
Halifax, HX3 0PW, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, HD3 3EA, United Kingdom
Nottingham City Hospital Campus, Department of Oncology
Nottingham, NG5 1PB, United Kingdom
Related Publications (2)
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.
PMID: 34553296DERIVEDSaura 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.
PMID: 32678716DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Clinical Operations
- Organization
- Puma Biotechnology, Inc.
Study Officials
- STUDY DIRECTOR
Senior Vice President Clinical Science and Pharmacology
Puma Biotechnology, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2013
First Posted
March 11, 2013
Study Start
March 29, 2013
Primary Completion
September 28, 2018
Study Completion
December 9, 2019
Last Updated
June 11, 2021
Results First Posted
December 11, 2019
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
- 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.
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.