AzTrials
AzTrials

HER2+ Metastatic Breast Cancer (MBC)Phase 3NALANCT01808573

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

A Phase 3 study testing neratinib, capecitabine and lapatinib in people with HER2+ Metastatic Breast Cancer (MBC), run by Puma Biotechnology, Inc. at 252 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2+ Metastatic Breast Cancer (MBC)
What is being tested?
neratinib, capecitabine and lapatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
621 participants
Where
252 sitesin 28 countries
Study dates
29 Mar 2013to 9 Dec 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

252 sites in 28 countries.

252 sites in 28 countries

United States79 sites

  • UCLA Hematology Oncology

    Alhambra, California, 91801

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory Clinic

    Atlanta, Georgia, 30322

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

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

    Bakersfield, California, 93309

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital

    Baltimore, Maryland, 21231

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

  • Resurrection Medical Group

    Chicago, Illinois, 60057

  • Siteman Cancer Center - St. Peters

    City of Saint Peters, Missouri, 63376

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • North Shore Oncology-Hematology Associates, Ltd.

    Crystal Lake, Illinois, 60014

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75235

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • North Shore Hematology Oncology Association PC

    East Setauket, New York, 11733

  • Compassionate Cancer Care Medical Group Inc.

    Fountain Valley, California, 92708

  • St. Jude Heritage Medical Group

    Fullerton, California, 92834

  • St. Jude Heritage Medical Group

    Fullerton, California, 92835

  • West Clinic PC

    Germantown, Tennessee, 38138

  • Ironwood Cancer and Research Centers

    Gilbert, Arizona, 95297

  • Marin Cancer Care, Inc.

    Greenbrae, California, 94904

  • UPMC Cancer Pavillion

    Greensburg, Pennsylvania, 15601

  • Primary Healthcare Associates, SC

    Harvey, Illinois, 60426

  • Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • North Shore Hematology Oncology

    Highland Park, Illinois, 60035

  • Primary Health Oncology

    Hobart, Indiana, 46342

  • St. Mary Medical Center

    Hobart, Indiana, 46342

  • OnCare Hawaii

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • UCLA Hematology Oncology

    Irvine, California, 92604

  • University of California San Diego Medical Center

    La Jolla, California, 92037

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92093-0698

  • Clinical Research Alliance

    Lake Success, New York, 11042

  • NYU Langone Medical Center

    Lake Success, New York, 11042

  • North Shore Oncology-Hematology Associates, Ltd.

    Libertyville, Illinois, 60048

  • Sidney Kimmel Comprehensive Cancer Center at John Hopkins at Greenspring Station

    Lutherville, Maryland, 21093

  • West Clinic PC

    Memphis, Tennessee, 38120

  • Ironwood Cancer and Research Centers

    Mesa, Arizona, 85206

  • UPMC Cancer Pavillion

    Monroeville, Pennsylvania, 15146

  • Community Hospital

    Munster, Indiana, 46321

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Clinical Research Alliance, Inc.

    New York, New York, 10021

  • Weill Cornell Medical College

    New York, New York, 10065

  • Breastlink Medical Group, Inc.

    Orange, California, 92868

  • University Hospitals Case Medical Center

    Orange, Ohio, 44122

  • UCLA Hematology Oncology

    Pasadena, California, 91005

  • Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC Cancer Pavillion

    Pittsburgh, Pennsylvania, 15215

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UPMC Cancer Pavillion

    Pittsburgh, Pennsylvania, 15237

  • Broward Medical Oncology Office

    Plantation, Florida, 33313

  • Florida Cancer Research Institute

    Plantation, Florida, 33324

  • UCLA Hematology Oncology

    Porter Ranch, California, 91326

  • Emad Ibrahim, MD

    Redlands, California, 92373

  • Cancer Care Associates Medical Group, Inc

    Redondo Beach, California, 90277

  • Compassionate Cancer Care Medical Group

    Riverside, California, 92501

  • University of California San Diego Medical Center - Hillcrest

    San Diego, California, 92103

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Breastlink Medical Group, Inc.

    Santa Ana, California, 92705

  • Cancer Center of Santa Barbara Sansum Clinic

    Santa Barbara, California, 93105

  • Central Coast Medical Oncology

    Santa Maria, California, 93454

  • UCLA Hematology Oncology

    Santa Monica, California, 90404

  • Ironwood Cancer and Research Centers

    Scottsdale, Arizona, 85202

  • Orchard Healthcare Research Inc

    Skokie, Illinois, 60077

  • Cancer Center of Santa Barbara

    Solvang, California, 93463

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129

  • Siteman Cancer Center - West County

    St Louis, Missouri, 63141

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

    Towson, Maryland, 21204

  • UPMC Cancer Pavillion

    Uniontown, Pennsylvania, 15401

  • UCLA Healthcare Santa Clarita Oncology

    Valencia, California, 91355

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • UPMC Cancer Pavillion

    West Mifflin, Pennsylvania, 15122

  • UCLA Hematology/Oncology

    Westlake Village, California, 91361

Other trials in United States

Italy16 sites

  • Hospital Papa Giovanni XXIII, Department of Medical Oncology

    Bergamo, 24127

  • Hospital Cervesi di Cattolica, Department of Oncology

    Cattolica, 47841

  • University G. D'Annunzio Chieti Pescara

    Chieti, 24127

  • Scientific Institute of Romagna of the Study and Treatment of Cancer

    Meldola, 47014

  • IRCCS - Hospital San Raffaele, Department of Medical Oncology

    Milan, 20132

  • European Institute of Oncology

    Milan, 20141

  • Azienda Ospedaliero San Gerardo

    Monza, 20900

  • National Cancer Institute - IRCCS "Fondazione G. Pascale"

    Naples, 80131

  • Hospital Sacro Cuore Don Calabria, Department of Medical Oncology

    Negrar, 37024

  • Azienda Ospedaliera Regionale San Carlo

    Potenza, 85100

  • Hospital Bianchi Melacrino Morelli

    Reggio Calabria, 89100

  • Hospital Infermi Rimini, Unit of Oncology

    Rimini, 47900

  • University Hospital Campus Bio-Medico

    Rome, 00128

  • National Cancer Institute Regina Elena

    Rome, 00144

  • Institute of Cancer Research and Treatment

    Torino, 10060

  • Hospital Desio and Vimercate, Department of Medical Oncology

    Vimercate, 20871

Other trials in Italy

Spain16 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Consorcio Hospitalario Provincial de Castellon

    Castellon, 12002

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

    Girona, 17007

  • Complejo Hospitalario Universitario Insular-Materno Infantil

    Las Palmas de Gran Canaria, 35016

  • Centro Oncologico MD Anderson

    Madrid, 28033

  • University Hospital Clinic San Carlos, Servicio de Oncologia Medica

    Madrid, 28040

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

    Madrid, 28041

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • University Hospital Quiron Madrid, Department of Oncology

    Madrid, 28223

  • Hospital Universitario Virgen de la Arrixaca, Servicio de Oncologia

    Murcia, 30120

  • Hospital Universitario Son Espases

    Palma de Mallorca, 07010

  • Hospital Son Llatzer, Servicio de Oncologia

    Palma de Mallorca, 07198

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • University Hospital Virgen del Rocio, Servicio de Oncologia

    Seville, 41013

  • Hospital Clinico Universitario de Valencia, Servicio de Oncologia

    Valencia, 46010

  • Hospital Clinico Universitario Lozano Blesa, Servicio de Oncologia

    Zaragoza, 50009

Other trials in Spain

Japan15 sites

  • Chiba University Hospital

    Chiba, Chiba, 260-8677

  • JCHO Kurume General Hospital

    Fukuoka, 830-0013

  • Gunma University Hospital

    Gunma, 371-8511

  • Hiroshima City Hospital

    Hiroshima, 730-8518

  • National Hospital Organization Hokkaido Cancer Center

    Hokkaido, 003-0804

  • Tokai University Hospital

    Isehara, Kanagawa, 2591193

  • Hakuaikai Medical Corporation Sagara Hospital

    Kagoshima, 892-0833

  • Saitama Cancer Centre

    Kitaadachi-gun, Saitama, 362-0806

  • Kobe City Medical Center General Hospital

    Kobe, Hyôgo, 650-0047

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556

  • Iwate Medical University Hospital

    Morioka, Iwate, 0208505

  • Osaka International Cancer Institute

    Osaka, 5418567

  • National Hospital Organization Osaka National Hospital

    Ôsaka, 540-0006

  • Toramonon Hospital

    Tokyo, 105-8470

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

Taiwan15 sites

  • Changhua Christian Hospital

    Changhua, Taiwan, Province of China

  • Buddhist Tzu-Chi General Hospital

    Hualien City, Taiwan, Province of China, 97002

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, Province of China, 83301

  • Chung-Ho Memorial Hospital

    Kaohsiung City, Taiwan, Province of China

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, Taiwan, Province of China

  • Taipei Tzu Chi General Hospital

    New Taipei City, 23142

  • Taichung Veterans General Hospital, Breast Center

    Taichung, Province of China, 40705

  • Kuang Tien General Hospital

    Taichung, 43303

  • National Cheng Kung University Hospital

    Tainan, Province of China, 70403

  • Chi Mei Medical Center - YK Branch

    Tainan, Province of China, 71004

  • Chi Mei Medical Center - LiouYing Branch

    Tainan, Province of China

  • Mackay Memorial Hospital

    Taipei, Province of China, 10449

  • Tri-Service General Hospital

    Taipei, Province of China

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

Brazil13 sites

  • Hospital de Cancer de Barretos - Hospital

    Barretos, São Paulo, 14784-400

  • 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

  • Liga Paranaense de Combate ao Cancer, Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336-045

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

    Goiânia, Goiás, 74605-070

  • Instituto Joinvillense de Hematologia e Oncologia

    Joinville, Santa Catarina, 89201-260

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Ribeiraopretano de Combate Ao Cancer - Clinic/Outpatient Facility

    Ribeirão Preto, São Paulo, 14015-130

  • Núcleo de Oncologia da Bahia - NOB

    Salvador, Estado de Bahia, 40170-110

  • Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética

    Salvador, Estado de Bahia, 41950-610

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

    São José do Rio Preto, São Paulo, 15090-000

  • Hospital Do Cancer A C Camargo - Hospital

    São Paulo, 01509-900

  • Instituto Brasileiro de Controle Do Câncer IBCC

    São Paulo, 03102-002

Other trials in Brazil

Canada13 sites

  • Abbotsford Regional Hospital and Cancer Care Centre

    Abbotsford British Columbia, British Columbia, V2S 0C2

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • British Columbia Cancer Agency

    Kelowna, British Columbia, V1Y 5L3

  • Grand River Hospital

    Kitchener, Ontario, N2G1G3

  • CHUM Notre Dame Hospital

    Montreal, Quebec, H2L 4M1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Ottawa Hospital, Cancer Center

    Ottawa, Ontario, K1H 8L6

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

    Québec, Quebec, G1S 4L8

  • Fraser Health Authority

    Surrey, British Columbia, V3V 1Z2

  • Toronto East General Hospital

    Toronto, Ontario, M4C 3E7

  • Sunnybrook Health Sciences Center, Odette Cancer Center

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital

    Toronto, Ontario, M5B1W8

Other trials in Canada

Israel10 sites

  • Soroka Medical Center

    Beersheba

  • Rambam Medical Center

    Haifa

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Medical Center

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center, Belinson Hospital

    Petah Tikva, 49100

  • Kaplan Medical Center, Department of Oncology

    Rehovot

  • Ziv Medical Center

    Safed, 13100

  • Sourasky Medical Center, Department of Oncology

    Tel Aviv, 64239

  • Chaim Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

Belgium9 sites

  • Our Dear Lady Hospital, Aalst Campus

    Aalst

  • Institut Jules Bordet - Medical Oncology

    Brussels, 1000

  • University Hospital Saint-Luc

    Brussels, 1200

  • Antwerp University Hospital

    Edegem, B-2650

  • Leuven University Hospitals

    Leuven, 3000

  • Clinic Saint-Joseph

    Liège, 4000

  • St. Elizabeth Maternity Clinic

    Namur, B-5000

  • AZ Damiaan General Hospital, Sint-Jozef Oncology Center

    Ostend

  • Saint-Augustinus Hospital

    Wilrijk, 2610

Other trials in Belgium

Australia7 sites

  • Bankstown-Lidcombe Hospital

    Bankstown, NSW 2200

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

  • St. George Hospital

    Kogarah, NSW 2217

  • Box Hill Hospital, Oncology Department

    Melbourne, 3128

  • Maroondah Hospital, Maroondah Breast Clinic

    Melbourne, 3135

  • The Tweed Hospital

    Tweed Heads, New South Wales, 2485

  • Sydney Adventist Hospital

    Wahroonga, 8833

Other trials in Australia

Germany7 sites

  • Hematology-Oncology Practice

    Augsburg, 86150

  • Practice for Oncology Bielefeld

    Bielefeld, 33604

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

    Cologne, 50931

  • University Hospital Schleswig-Holstein

    Kiel, 24105

  • Otto von Guericke University of Magdeburg

    Magdeburg, D-39106

  • Onkologie Ravensburg

    Ravensburg, 88212

  • University Hospital Ulm

    Ulm, 89075

Other trials in Germany

Singapore7 sites

  • National University Hospital

    Singapore, 119228

  • National Cancer Centre Singapore, Department of Medical Oncology

    Singapore, 169610

  • Raffles Hospital

    Singapore, 188770

  • Icon Singapore Oncology Consultants Farrer Park Medical Clinic

    Singapore, 217562

  • Gleneagles Medical Centre, Center for Medical Oncology

    Singapore, 258500

  • Parkway Cancer Centre

    Singapore, 258500

  • Johns Hopkins Singapore International Medical Center

    Singapore, 308433

Other trials in Singapore

Hong Kong6 sites

  • Queen Elizabeth Hospital, Department of Clinical Oncology

    Hong Kong

  • Queen Mary Hospital, Department of Clinical Oncology

    Hong Kong

  • Queen Mary Hospital, Department of Oncology

    Hong Kong

  • Queen Mary Hospital, Department of Surgery

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

  • Prince of Wales Hospital

    Shatin, New Territories

Other trials in Hong Kong

United Kingdom6 sites

  • Queen Elizabeth Hospital Birmingham

    Birmingham, West Midlands, B15 2TH

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • Colchester General Hospital

    Colchester, Essex, CO4 5JL

  • Calderdale Royal Hospital, Macmillan Unit

    Halifax, HX3 0PW

  • Huddersfield Royal Infirmary

    Huddersfield, HD3 3EA

  • Nottingham City Hospital Campus, Department of Oncology

    Nottingham, NG5 1PB

Other trials in United Kingdom

France5 sites

  • Center Jean Perrin

    Clermont-Ferrand, 63011

  • Saint-Louis Hospital

    Paris, 75010

  • South Lyon Hospital Center, Department of Clinical Hematology and Medical Oncology

    Pierre-Bénite, Lyon, 69495

  • Clinic Sainte Anne, Center for Radiotherapy

    Strasbourg, 67000

  • Gustave Roussy Oncology Institute, Department of Medicine

    Villejuif, 94805

Other trials in France

Switzerland4 sites

  • Hospital Engeried

    Bern, CH-3012

  • University Hospital of Geneva

    Geneva, CH-1211

  • Canton Hospital Winterthur

    Winterthur, 8401

  • Onkozentrum Zurich - Kinik im Park

    Zurich, 8038

Other trials in Switzerland

Czechia3 sites

  • Masaryk Memorial Cancer Institute

    Brno

  • Hospital Novy Jicin

    Nový Jičín, 74101

  • University Hospital Motol, Comprehensive Oncology Center

    Prague, 150 06

Other trials in Czechia

Portugal3 sites

  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE

    Lisbon, 1099-023

  • Centro de Investigação Clinica, Hospital da Luz

    Lisbon, 1500-650

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

    Porto, 4200-072

Other trials in Portugal

Russia3 sites

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

    Moscow, Moscow, 129301

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

    Moscow, 115478

  • Tambov Regional Oncological Center

    Tambov, 392013

Other trials in Russia

South Korea3 sites

  • National Cancer Center

    Gyeonggi-do

  • Severance Hospital

    Seoul, 120-752

  • Asan Medical Center

    Seoul

Other trials in South Korea

Argentina2 sites

  • COIBA Centro de Oncología e Investigación Buenos Aires

    Berazategui, Buenos Aires, B1880BBF

  • Fundación Investigar

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1025ABI

Other trials in Argentina

Ireland2 sites

  • St. Jame's Hospital

    Dublin

  • St. Vincent's University Hospital

    Dublin

Other trials in Ireland

Sweden2 sites

  • Orebro University Hospital, Department of Oncology

    Örebro

  • Uppsala University Hospital, Department of Oncology

    Uppsala

Other trials in Sweden

Turkey (Türkiye)2 sites

  • Ege University

    Bornova, İzmir, 35100

  • Marmara University Faculty of Medicine

    Istanbul, 34890

Other trials in Turkey (Türkiye)

Austria1 site

  • University Hospital Innsbruck - Tyrolean Hospital, Department of Gynecology

    Innsbruck, 6020

Other trials in Austria

Denmark1 site

  • Sjaelland University Hospital

    Næstved, 4700

Other trials in Denmark

Finland1 site

  • Helsinki University Central Hospital, Department of Oncology

    Helsinki, 00029

Other trials in Finland

Netherlands1 site

  • Maastricht University Medical Centre (MUMC)

    Maastricht, 6229 HX

Other trials in Netherlands

About this study

Official title: A STUDY OF NERATINIB PLUS CAPECITABINE VERSUS LAPATINIB PLUS CAPECITABINE IN PATIENTS WITH HER2+ METASTATIC BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR HER2-DIRECTED REGIMENS IN THE METASTATIC SETTING (NALA)

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.

Read the 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.

Being tested
neratinib, capecitabine, lapatinib
Keywords
Neratinib, Nerlynx

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • neratinibDrug

    Also called Nerlynx

  • capecitabineDrug

    Also called Xeloda

  • lapatinibDrug

    Also called Tykerb, Tyverb

Study groups in NCT01808573
Study groupRoleWhat they receive
neratinib plus capecitabineExperimentalneratinib 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.
Receives: Drug: neratinib; Drug: capecitabine
lapatinib plus capecitabineActive 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.
Receives: Drug: capecitabine; Drug: lapatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut.

  2. 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.

    Measured: From randomization date to death, assessed up to 59 months.The result is based on primary analysis data cut.

Secondary outcomes (5)

  1. Intervention for Symptomatic Metastatic Central Nervous System Disease

    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.

    Measured: 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.

  2. Objective Response Rate (ORR) - Central Assessment (ITT Population With Measurable Disease at Screening)

    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.

    Measured: 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.

  3. Clinical Benefit Rate (CBR) - Central Assessment (ITT Population With Measurable Disease at Screening)

    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.

    Measured: 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.

  4. Duration of Response (DOR) - Central Assessment (Population That Had a Response With Measurable Disease at Screening)

    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.

    Measured: From start date of response after randomization to first PD, up to 33 months.The result is based on primary analysis data cut.

  5. Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events)

    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

    Measured: From first dose through last dose + 28 days, up to 41 months. The result is based on final data cut.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2013 (estimated)
  2. Study start29 Mar 2013
  3. Primary completion28 Sep 2018
  4. Study completion9 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
621 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01808573
Sponsor's protocol ID
PUMA-NER-1301
Other IDs
2012-004492-38, UTN U1111-1161-1603
Acronym
NALA
Status last verified
May 2021
First submitted
4 Mar 2013
Last updated
11 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 34553296

  • Saura C, Oliveira M, Feng YH, Dai MS, Chen SW, Hurvitz SA, Kim SB, Moy B, Delaloge S, Gradishar W, Masuda N, Palacova M, Trudeau ME, Mattson J, Yap YS, Hou MF, De Laurentiis M, Yeh YM, Chang HT, Yau T, Wildiers H, Haley B, Fagnani D, Lu YS, Crown J, Lin J, Takahashi M, Takano T, Yamaguchi M, Fujii T, Yao B, Bebchuk J, Keyvanjah K, Bryce R, Brufsky A; NALA Investigators. Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer Previously Treated With >/= 2 HER2-Directed Regimens: Phase III NALA Trial. J Clin Oncol. 2020 Sep 20;38(27):3138-3149. doi: 10.1200/JCO.20.00147. Epub 2020 Jul 17.

    PubMed 32678716

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing neratinib, capecitabine and lapatinib in people with HER2+ Metastatic Breast Cancer (MBC), run by Puma Biotechnology, Inc. at 252 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 252 sites in United States, Italy, Spain, Japan, Taiwan and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01808573, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.

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