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

NCT ID: NCT01808573

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 621 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-29
• Study Completion Date: 2019-12-09

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.

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.

Conditions

HER2+ Metastatic Breast Cancer (MBC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

neratinib

Intervention Type: DRUG

capecitabine

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

capecitabine

Intervention Type: DRUG

lapatinib

Intervention Type: DRUG

Interventions

neratinib

Intervention Type: DRUG

capecitabine

Intervention Type: DRUG

lapatinib

Intervention Type: DRUG

Other Intervention Names

Nerlynx; Xeloda; Tykerb; Tyverb

Eligibility Criteria

Inclusion Criteria

• Aged ≥18 years at signing of informed consent.
• Histologically confirmed MBC, current stage IV.
• Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+, with confirmatory fluorescence in situ hybridization (FISH) +.
• Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.

Exclusion Criteria

• Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Puma Biotechnology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Senior Vice President Clinical Science and Pharmacology

Role: STUDY_DIRECTOR

Puma Biotechnology, Inc.

Locations

Azienda Ospedaliera Regionale San Carlo

Potenza, , Italy

Hospital Bianchi Melacrino Morelli

Reggio Calabria, , Italy

Hospital Infermi Rimini, Unit of Oncology

Rimini, , Italy

University Hospital Campus Bio-Medico

Rome, , Italy

National Cancer Institute Regina Elena

Rome, , Italy

Institute of Cancer Research and Treatment

Torino, , Italy

Hospital Desio and Vimercate, Department of Medical Oncology

Vimercate, , Italy

Chiba University Hospital

Chiba, Chiba, Japan

Kobe City Medical Center General Hospital

Kobe, Hyôgo, Japan

University of Tsukuba Hospital

Tsukuba, Ibaraki, Japan

Iwate Medical University Hospital

Morioka, Iwate, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Saitama Cancer Centre

Kitaadachi-gun, Saitama, Japan

JCHO Kurume General Hospital

Fukuoka, , Japan

Gunma University Hospital

Gunma, , Japan

Hiroshima City Hospital

Hiroshima, , Japan

National Hospital Organization Hokkaido Cancer Center

Hokkaido, , Japan

Hakuaikai Medical Corporation Sagara Hospital

Kagoshima, , Japan

Osaka International Cancer Institute

Osaka, , Japan

National Hospital Organization Osaka National Hospital

Ôsaka, , Japan

Toramonon Hospital

Tokyo, , Japan

Maastricht University Medical Centre (MUMC)

Maastricht, , Netherlands

Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE

Lisbon, , Portugal

Centro de Investigação Clinica, Hospital da Luz

Lisbon, , Portugal

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

Porto, , Portugal

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

Moscow, Moscow, Russia

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

Moscow, , Russia

Tambov Regional Oncological Center

Tambov, , Russia

National University Hospital

Singapore, , Singapore

Ironwood Cancer and Research Centers

Chandler, Arizona, United States

Ironwood Cancer and Research Centers

Gilbert, Arizona, United States

Ironwood Cancer and Research Centers

Mesa, Arizona, United States

Ironwood Cancer and Research Centers

Scottsdale, Arizona, United States

UCLA Hematology Oncology

Alhambra, California, United States

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

Bakersfield, California, United States

Compassionate Cancer Care Medical Group Inc.

Fountain Valley, California, United States

St. Jude Heritage Medical Group

Fullerton, California, United States

St. Jude Heritage Medical Group

Fullerton, California, United States

Marin Cancer Care, Inc.

Greenbrae, California, United States

UCLA Hematology Oncology

Irvine, California, United States

University of California San Diego Medical Center

La Jolla, California, United States

University of California San Diego Moores Cancer Center

La Jolla, California, United States

Breastlink Medical Group, Inc.

Orange, California, United States

UCLA Hematology Oncology

Pasadena, California, United States

UCLA Hematology Oncology

Porter Ranch, California, United States

Emad Ibrahim, MD

Redlands, California, United States

Cancer Care Associates Medical Group, Inc

Redondo Beach, California, United States

Compassionate Cancer Care Medical Group

Riverside, California, United States

University of California San Diego Medical Center - Hillcrest

San Diego, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Breastlink Medical Group, Inc.

Santa Ana, California, United States

Cancer Center of Santa Barbara Sansum Clinic

Santa Barbara, California, United States

Central Coast Medical Oncology

Santa Maria, California, United States

UCLA Hematology Oncology

Santa Monica, California, United States

Cancer Center of Santa Barbara

Solvang, California, United States

UCLA Healthcare Santa Clarita Oncology

Valencia, California, United States

UCLA Hematology/Oncology

Westlake Village, California, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Broward Medical Oncology Office

Plantation, Florida, United States

Florida Cancer Research Institute

Plantation, Florida, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory Clinic

Atlanta, Georgia, United States

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

OnCare Hawaii

Honolulu, Hawaii, United States

Queen's Medical Center

Honolulu, Hawaii, United States

Straub Clinic and Hospital

Honolulu, Hawaii, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Resurrection Medical Group

Chicago, Illinois, United States

North Shore Oncology-Hematology Associates, Ltd.

Crystal Lake, Illinois, United States

Primary Healthcare Associates, SC

Harvey, Illinois, United States

North Shore Hematology Oncology

Highland Park, Illinois, United States

North Shore Oncology-Hematology Associates, Ltd.

Libertyville, Illinois, United States

Orchard Healthcare Research Inc

Skokie, Illinois, United States

Primary Health Oncology

Hobart, Indiana, United States

St. Mary Medical Center

Hobart, Indiana, United States

Community Hospital

Munster, Indiana, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital

Baltimore, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center at John Hopkins at Greenspring Station

Lutherville, Maryland, United States

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

Towson, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Siteman Cancer Center - St. Peters

City of Saint Peters, Missouri, United States

Washington University in St. Louis

St Louis, Missouri, United States

Siteman Cancer Center - South County

St Louis, Missouri, United States

Siteman Cancer Center - West County

St Louis, Missouri, United States

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

North Shore Hematology Oncology Association PC

East Setauket, New York, United States

Clinical Research Alliance

Lake Success, New York, United States

NYU Langone Medical Center

Lake Success, New York, United States

Clinical Research Alliance, Inc.

New York, New York, United States

Weill Cornell Medical College

New York, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

University Hospitals Case Medical Center

Orange, Ohio, United States

UPMC Cancer Pavillion

Greensburg, Pennsylvania, United States

Hershey Medical Center

Hershey, Pennsylvania, United States

UPMC Cancer Pavillion

Monroeville, Pennsylvania, United States

Magee Women's Hospital

Pittsburgh, Pennsylvania, United States

UPMC Cancer Pavillion

Pittsburgh, Pennsylvania, United States

Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

UPMC Cancer Pavillion

Pittsburgh, Pennsylvania, United States

UPMC Cancer Pavillion

Uniontown, Pennsylvania, United States

UPMC Cancer Pavillion

West Mifflin, Pennsylvania, United States

West Clinic PC

Germantown, Tennessee, United States

West Clinic PC

Memphis, Tennessee, United States

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

COIBA Centro de Oncología e Investigación Buenos Aires

Berazategui, Buenos Aires, Argentina

Fundación Investigar

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

The Tweed Hospital

Tweed Heads, New South Wales, Australia

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Bankstown-Lidcombe Hospital

Bankstown, , Australia

St. George Hospital

Kogarah, , Australia

Box Hill Hospital, Oncology Department

Melbourne, , Australia

Maroondah Hospital, Maroondah Breast Clinic

Melbourne, , Australia

Sydney Adventist Hospital

Wahroonga, , Australia

University Hospital Innsbruck - Tyrolean Hospital, Department of Gynecology

Innsbruck, , Austria

Our Dear Lady Hospital, Aalst Campus

Aalst, , Belgium

Institut Jules Bordet - Medical Oncology

Brussels, , Belgium

University Hospital Saint-Luc

Brussels, , Belgium

Antwerp University Hospital

Edegem, , Belgium

Leuven University Hospitals

Leuven, , Belgium

Clinic Saint-Joseph

Liège, , Belgium

St. Elizabeth Maternity Clinic

Namur, , Belgium

AZ Damiaan General Hospital, Sint-Jozef Oncology Center

Ostend, , Belgium

Saint-Augustinus Hospital

Wilrijk, , Belgium

Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Núcleo de Oncologia da Bahia - NOB

Salvador, Estado de Bahia, Brazil

Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética

Salvador, Estado de Bahia, Brazil

Hospital Araújo Jorge, Associação de Combate ao Câncer em Goiás

Goiânia, Goiás, Brazil

Liga Paranaense de Combate ao Cancer, Hospital Erasto Gaertner

Curitiba, Paraná, 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, Brazil

Hospital Sao Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Instituto Joinvillense de Hematologia e Oncologia

Joinville, Santa Catarina, Brazil

Hospital de Cancer de Barretos - Hospital

Barretos, São Paulo, Brazil

Instituto Ribeiraopretano de Combate Ao Cancer - Clinic/Outpatient Facility

Ribeirão Preto, São Paulo, Brazil

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

São José do Rio Preto, São Paulo, Brazil

Hospital Do Cancer A C Camargo - Hospital

São Paulo, , Brazil

Instituto Brasileiro de Controle Do Câncer IBCC

São Paulo, , Brazil

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Abbotsford Regional Hospital and Cancer Care Centre

Abbotsford, British Columbia, Canada

British Columbia Cancer Agency

Kelowna, British Columbia, Canada

Fraser Health Authority

Surrey, British Columbia, Canada

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Grand River Hospital

Kitchener, Ontario, Canada

Ottawa Hospital, Cancer Center

Ottawa, Ontario, Canada

Toronto East General Hospital

Toronto, Ontario, Canada

Sunnybrook Health Sciences Center, Odette Cancer Center

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

CHUM Notre Dame Hospital

Montreal, Quebec, Canada

Montreal General Hospital

Montreal, Quebec, Canada

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

Québec, Quebec, Canada

Masaryk Memorial Cancer Institute

Brno, , Czechia

Hospital Novy Jicin

Nový Jičín, , Czechia

University Hospital Motol, Comprehensive Oncology Center

Prague, , Czechia

Sjaelland University Hospital

Næstved, , Denmark

Helsinki University Central Hospital, Department of Oncology

Helsinki, , Finland

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

Pierre-Bénite, Lyon, France

Center Jean Perrin

Clermont-Ferrand, , France

Saint-Louis Hospital

Paris, , France

Clinic Sainte Anne, Center for Radiotherapy

Strasbourg, , France

Gustave Roussy Oncology Institute, Department of Medicine

Villejuif, , France

Hematology-Oncology Practice

Augsburg, , Germany

Practice for Oncology Bielefeld

Bielefeld, , Germany

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

Cologne, , Germany

University Hospital Schleswig-Holstein

Kiel, , Germany

Otto von Guericke University of Magdeburg

Magdeburg, , Germany

Onkologie Ravensburg

Ravensburg, , Germany

University Hospital Ulm

Ulm, , 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, , Israel

Hadassah Medical Center

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Rabin Medical Center, Belinson Hospital

Petah Tikva, , Israel

Kaplan Medical Center, Department of Oncology

Rehovot, , Israel

Ziv Medical Center

Safed, , Israel

Sourasky Medical Center, Department of Oncology

Tel Aviv, , Israel

Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Hospital Papa Giovanni XXIII, Department of Medical Oncology

Bergamo, , Italy

Hospital Cervesi di Cattolica, Department of Oncology

Cattolica, , Italy

University G. D'Annunzio Chieti Pescara

Chieti, , Italy

Scientific Institute of Romagna of the Study and Treatment of Cancer

Meldola, , Italy

IRCCS - Hospital San Raffaele, Department of Medical Oncology

Milan, , Italy

European Institute of Oncology

Milan, , Italy

Azienda Ospedaliero San Gerardo

Monza, , Italy

National Cancer Institute - IRCCS "Fondazione G. Pascale"

Naples, , Italy

Hospital Sacro Cuore Don Calabria, Department of Medical Oncology

Negrar, , Italy

National Cancer Centre Singapore, Department of Medical Oncology

Singapore, , Singapore

Raffles Hospital

Singapore, , Singapore

Icon Singapore Oncology Consultants Farrer Park Medical Clinic

Singapore, , Singapore

Gleneagles Medical Centre, Center for Medical Oncology

Singapore, , Singapore

Parkway Cancer Centre

Singapore, , Singapore

Johns Hopkins Singapore International Medical Center

Singapore, , Singapore

National Cancer Center

Gyeonggi-do, , South Korea

Severance Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Consorcio Hospitalario Provincial de Castellon

Castellon, , Spain

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

Girona, , Spain

Complejo Hospitalario Universitario Insular-Materno Infantil

Las Palmas de Gran Canaria, , Spain

Centro Oncologico MD Anderson

Madrid, , Spain

University Hospital Clinic San Carlos, Servicio de Oncologia Medica

Madrid, , Spain

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

Madrid, , Spain

Centro Integral Oncologico Clara Campal

Madrid, , Spain

University Hospital Quiron Madrid, Department of Oncology

Madrid, , Spain

Hospital Universitario Virgen de la Arrixaca, Servicio de Oncologia

Murcia, , Spain

Hospital Universitario Son Espases

Palma de Mallorca, , Spain

Hospital Son Llatzer, Servicio de Oncologia

Palma de Mallorca, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

University Hospital Virgen del Rocio, Servicio de Oncologia

Seville, , Spain

Hospital Clinico Universitario de Valencia, Servicio de Oncologia

Valencia, , Spain

Hospital Clinico Universitario Lozano Blesa, Servicio de Oncologia

Zaragoza, , Spain

Orebro University Hospital, Department of Oncology

Örebro, , Sweden

Uppsala University Hospital, Department of Oncology

Uppsala, , Sweden

Hospital Engeried

Bern, , Switzerland

University Hospital of Geneva

Geneva, , Switzerland

Canton Hospital Winterthur

Winterthur, , Switzerland

Onkozentrum Zurich - Kinik im Park

Zurich, , Switzerland

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Province of China, Taiwan

Taichung Veterans General Hospital, Breast Center

Taichung, Province of China, Taiwan

National Cheng Kung University Hospital

Tainan City, Province of China, Taiwan

Chi Mei Medical Center - YK Branch

Tainan City, Province of China, Taiwan

Chi Mei Medical Center - LiouYing Branch

Tainan City, Province of China, Taiwan

Mackay Memorial Hospital

Taipei, Province of China, 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, 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, , Taiwan

Kuang Tien General Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Ege University

Bornova, İzmir, Turkey (Türkiye)

Marmara University Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Colchester General Hospital

Colchester, Essex, United Kingdom

Queen Elizabeth Hospital Birmingham

Birmingham, West Midlands, United Kingdom

Velindre Cancer Centre

Cardiff, , United Kingdom

Calderdale Royal Hospital, Macmillan Unit

Halifax, , United Kingdom

Huddersfield Royal Infirmary

Huddersfield, , United Kingdom

Nottingham City Hospital Campus, Department of Oncology

Nottingham, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Czechia; Denmark; Finland; France; Germany; Hong Kong; Ireland; Israel; Italy; Japan; Netherlands; Portugal; Russia; Singapore; South Korea; Spain; Sweden; Switzerland; Taiwan; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34553296 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32678716 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2012-004492-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UTN U1111-1161-1603

Identifier Type: OTHER

Identifier Source: secondary_id

PUMA-NER-1301

Identifier Type: -

Identifier Source: org_study_id