Clinical trial NCT00045032: Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer
Official title: A Randomized Three-Arm, Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Breast International Group
name: European Organisation for Research and Treatment of Cancer - EORTC
name: NCIC Clinical Trials Group
name: ETOP IBCSG Partners Foundation
First posted: 2003-01-27
Enrollment: 5099
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.


Eligibility criteria: Inclusion Criteria:

* Non-metastatic primary invasive breast cancer overexpressing HER2 (determined by immunohistochemistry 3+ or positive fluorescence in situ hybridization test) that has been histologically confirmed, adequately excised, axillary node positive or negative, and tumor size at least T1c according to Tumor/Node/Metastasis (TNM) staging
* Completion of at least 4 cycles of (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable
* Known hormone receptor status
* Baseline left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55 percent (%)

Exclusion Criteria:

* Prior invasive breast carcinoma
* Other malignancies except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
* Clinical T4 tumors
* Cumulative doxorubicin exposure greater than (\>) 360 milligrams per meter-squared (mg/m\^2) or epirubicin \>720 mg/m\^2 or any prior anthracyclines unrelated to the present breast cancer
* Peripheral stem cell or bone marrow stem cell support
* Prior mediastinal irradiation except for internal mammary node irradiation for the present breast cancer
* Non-irradiated internal mammary nodes or supraclavicular lymph node involvement
* Prior anti-HER2 therapy for any other reason or other prior biologic or immunotherapy for breast cancer
* Concurrent anti-cancer treatment in another investigational trial
* Serious cardiac or pulmonary conditions/illness, or any other conditions that could interfere with planned treatment
* Poor hematologic, hepatic, or renal function
* Pregnancy or lactation
* Women of childbearing potential or less than 1 year post-menopause unwilling to use adequate contraceptive measures

Primary outcomes:
measure: Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 1 year)
measure: Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 1 year)
measure: DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up
timeFrame: Year 2
measure: DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up
timeFrame: Year 2
measure: Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 8 years)
measure: DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
timeFrame: Year 3
measure: DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
timeFrame: Year 5
measure: DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
timeFrame: Year 7
measure: DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
timeFrame: Year 8
measure: Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum Follow-Up
timeFrame: From Baseline until time of event (maximum of 10 years)
measure: DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
timeFrame: Year 3
measure: DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
timeFrame: Year 5
measure: DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
timeFrame: Year 7
measure: DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
timeFrame: Year 8
measure: DFS Rate at Year 9 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
timeFrame: Year 9
measure: DFS Rate at Year 10 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
timeFrame: Year 10
Secondary outcomes:
measure: Percentage of Participants With DFS Events in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up
timeFrame: From Baseline until time of event (maximum of 10 years)
measure: DFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up
timeFrame: Years 3, 5, 7, 8, 9, 10
measure: Percentage of Participants With Overall Survival (OS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 1 year)
measure: Percentage of Participants With OS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 1 year)
measure: OS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up
timeFrame: Year 2
measure: OS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up
timeFrame: Year 2
measure: Percentage of Participants With OS Events Compared to Observation: 8-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 8 years)
measure: OS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
timeFrame: Years 3, 5, 7, 8
measure: Percentage of Participants With OS Events Compared to Observation: 11-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 11 years)
measure: OS Rate According to Kaplan-Meier Analysis Compared to Observation: 11-Year Median Follow-Up
timeFrame: Years 3, 5, 7, 9, 10, 11, 12
measure: Percentage of Participants With OS Events in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 11 years)
measure: OS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up
timeFrame: Years 3, 5, 7, 9, 10, 11, 12
measure: Percentage of Participants With Recurrence-Free Survival (RFS) Events Compared to Observation: 8-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 8 years)
measure: RFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
timeFrame: Years 3, 5, 7, 8
measure: Percentage of Participants With RFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 8 years)
measure: RFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
timeFrame: Years 3, 5, 7, 8
measure: Percentage of Participants With Distant Disease-Free Survival (DDFS) Events Compared to Observation: 8-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 8 years)
measure: DDFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
timeFrame: Years 3, 5, 7, 8
measure: Percentage of Participants With DDFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 8 years)
measure: DDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
timeFrame: Years 3, 5, 7, 8
measure: Percentage of Participants With Tumor Recurrence (TR) Compared to Observation: 8-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 8 years)
measure: TR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
timeFrame: Years 3, 5, 7, 8
measure: Percentage of Participants With TR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 8 years)
measure: TR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
timeFrame: Years 3, 5, 7, 8
measure: Percentage of Participants With Distant Tumor Recurrence (DTR) Compared to Observation: 8-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 8 years)
measure: DTR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
timeFrame: Years 3, 5, 7, 8
measure: Percentage of Participants With DTR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 8 years)
measure: DTR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
timeFrame: Years 3, 5, 7, 8
measure: Percentage of Participants With Restricted Disease-Free Survival (RDFS) Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
timeFrame: From Baseline until time of event (median of 8 years)
measure: RDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
timeFrame: Years 3, 5, 7, 8
measure: Percentage of Participants With Primary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up
timeFrame: From Baseline until time of event (maximum up to 10 years)
measure: Percentage of Participants With Secondary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up
timeFrame: From Baseline until time of event (maximum up to 10 years)
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Aleman de Buenos Aires
city: Geelong
country: Australia
facility: Saint John of God Hospital
state: Australian Capital Territory
city: Toowoomba
country: Australia
facility: Toowoomba Hospital
state: Queensland
city: Geelong
country: Australia
facility: Andrew Love Cancer Centre
state: Victoria
city: Perth
country: Australia
facility: Mount Hospital
state: Western Australia
city: Feldkirch-Tisis
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Innsbruck
country: Austria
facility: Innsbruck Universitaetsklinik
city: Klagenfurt
country: Austria
facility: Landeskrankenhaus Klagenfurt
city: Linz Donau
country: Austria
facility: St. Vincent's Hospital
city: Salzburg
country: Austria
facility: Landeskrankenanstalten - Salzburg
city: St. Poelten
country: Austria
facility: Landeskrankenhaus St. Poelten
city: Vienna
country: Austria
facility: Universitaetsklinik fuer Innere Medizin I
city: Vienna
country: Austria
facility: Wilhelminenspital der Stadt Wien
city: Villach
country: Austria
facility: LKH Villach
city: Voecklabruck
country: Austria
facility: LKH Voecklabruck
city: Wiener Neustadt
country: Austria
facility: A. oe. Krankenhaus Wiener Neustadt
city: Antwerp
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen Middelheim
city: Baudour
country: Belgium
facility: Reseau Hospitalier De Medecine Sociale
city: Brussels
country: Belgium
facility: Hopital Universitaire Erasme
city: Brussels
country: Belgium
facility: Academisch Ziekenhuis der Vrije Universiteit Brussel
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Charleroi
country: Belgium
facility: Centre Hospitalier Notre Dame - Reine Fabiola
city: Kortrijk
country: Belgium
facility: Cazk Groeninghe - Campus St-Niklaas
city: La Louviere
country: Belgium
facility: Centre Hospitalier Universitaire de Tivoli
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Liege
country: Belgium
facility: Clinique Saint-Joseph
city: Liege
country: Belgium
facility: CHU Liege - Domaine Universitaire du Sart Tilman
city: Namur
country: Belgium
facility: Clinique Sainte Elisabeth
city: Oostende
country: Belgium
facility: Hospital Serruys Ziekenhuis
city: Verviers
country: Belgium
facility: Centre Hospitalier Peltzer-La Tourelle
city: Porto Alegre
country: Brazil
facility: Porto Alegre Hospital
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
city: Porto Alegre
country: Brazil
facility: Hospital Santa Rita
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer
city: Santo Andre
country: Brazil
facility: Faculdade De Medicina Do ABC
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre - Calgary
state: Alberta
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency - Centre for the Southern Interior
state: British Columbia
city: Surrey
country: Canada
facility: Fraser Valley Cancer Centre at British Columbia Cancer Agency
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency - Vancouver Cancer Centre
state: British Columbia
city: Victoria
country: Canada
facility: British Columbia Cancer Agency - Vancouver Island Cancer Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Barrie
country: Canada
facility: Royal Victoria Hospital of Barrie
state: Ontario
city: Hamilton
country: Canada
facility: Margaret and Charles Juravinski Cancer Centre
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Centre - Mississauga Site
state: Ontario
city: Sault Sainte Marie
country: Canada
facility: Algoma Regional Cancer Program at Sault Area Hospital
state: Ontario
city: St. Catharines
country: Canada
facility: Hotel Dieu Health Sciences Hospital - Niagara
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital - Toronto
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre at Windsor Regional Hospital
state: Ontario
city: Charlottetown
country: Canada
facility: Prince Edward Island Cancer Centre at Queen Elizabeth Hospital
state: Prince Edward Island
city: Quebec City
country: Canada
facility: Hopital du Saint-Sacrement, Quebec
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre at Pasqua Hospital
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre at the University of Saskatchewan
state: Saskatchewan
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez
city: Santiago
country: Chile
facility: Hospital Clinico San Borja Arriaran
city: Santiago
country: Chile
facility: Hospital Dr. Sotero Del Rio
city: Santiago
country: Chile
facility: Hospital Militar
city: Santiago
country: Chile
facility: Instituto Nacional Del Cancer
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Hong Kong
country: China
facility: Tuen Mun Hospital
city: Wuhan
country: China
facility: Tongji Medical University
city: Bogota
country: Colombia
facility: Instituto Nacional De Cancerologia
city: Split
country: Croatia
facility: Clinical Hospital Center Split
city: Esbjerg
country: Denmark
facility: Centralsygehus I Esbjerg
city: Herning
country: Denmark
facility: Herning Central Hospital
city: Hillerod
country: Denmark
facility: Hillerod Hospital
city: Naestved
country: Denmark
facility: Centralsygehuset I Naestved
city: Sonderborg
country: Denmark
facility: Sonderborg Sygehus
city: Caen
country: France
facility: Centre Regional Francois Baclesse
city: Limoges
country: France
facility: Centre Hospital Regional Universitaire de Limoges
city: Metz
country: France
facility: Hopital Clinique Claude Bernard
city: Berlin
country: Germany
facility: Charite - Campus Charite Mitte
city: Essen
country: Germany
facility: Evangelisches Bethesda Krankenhaus GmbH
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Halle
country: Germany
facility: Martin Luther Universitaet
city: Hanover
country: Germany
facility: Henriettenstiftung Krankenhaus
city: Heidelberg
country: Germany
facility: Universitaets-Hautklinik Heidelberg
city: Karlsruhe
country: Germany
facility: St. Vincentius-Kliniken
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein - Kiel Campus
city: Leonberg
country: Germany
facility: Kreiskrankenhaus Leonberg - Frauenklinik
city: Magdeburg
country: Germany
facility: Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
city: Munich
country: Germany
facility: Frauenklinik Vom Roten Kreuz
city: Munich
country: Germany
facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen
city: Rostock
country: Germany
facility: Frauenklinik - Universitaetsklinikum Rostock am Klinikum Sudstadt
city: Ulm
country: Germany
facility: Universitaet Ulm
city: Wiesbaden
country: Germany
facility: Dr. Horst-Schmidt-Kliniken
city: Heraklion
country: Greece
facility: University of Crete School of Medicine
state: Crete
city: Athens
country: Greece
facility: Evaggelismos Hospital
city: Guatemala City
country: Guatemala
facility: Centro Medico
city: Guatemala City
country: Guatemala
facility: Hospital Roosevelt
city: Shatin, New Territories
country: Hong Kong
facility: Prince of Wales Hospital
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Budapest
country: Hungary
facility: Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia
city: Cork
country: Ireland
facility: Cork University Hospital
city: Safed
country: Israel
facility: Sieff Hospital
city: Alba
country: Italy
facility: Ospedale San Lazzaro
city: Alzano-Lombardo
country: Italy
facility: Ospedale Presenti Fenaroli
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - Aviano
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
city: Biella
country: Italy
facility: Ospedale degli Infermi - ASL 12
city: Bologna
country: Italy
facility: Ospedale Bellaria
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Cagliari
country: Italy
facility: Ospedale Oncologico A. Businco
city: Carpi
country: Italy
facility: Ospedale B. Ramazzini
city: Como
country: Italy
facility: Ospedale Valduce
city: Cuneo
country: Italy
facility: Ospedale Santa Croce
city: Firenze (Florence)
country: Italy
facility: Universita Degli Studi Di Florence
city: Florence
country: Italy
facility: Azienda Ospedaliero Careggi
city: Forli
country: Italy
facility: Morgagni-Pierantoni Ospedale
city: Genoa
country: Italy
facility: Istituto Nazionale per la Ricerca sul Cancro
city: Lecco
country: Italy
facility: Ospedale A. Manzoni
city: Livorno
country: Italy
facility: Presidio Ospedaliero
city: Mantova
country: Italy
facility: Carlo Poma Hospital
city: Milan
country: Italy
facility: European Institute of Oncology
city: Milan
country: Italy
facility: Ospedale Niguarda Ca'Granda
city: Modena
country: Italy
facility: University of Modena Hospital and Reggio Emilia School of Medicine
city: Parma
country: Italy
facility: Azienda Ospedaliera Di Parma
city: Pavia
country: Italy
facility: I.R.C.C.S. Policlinico San Matteo
city: Perugia
country: Italy
facility: Policlinico Monteluce
city: Reggio Emilia
country: Italy
facility: Azienda Ospedaliera
city: Rome
country: Italy
facility: Ospedale San Filippo Neri
city: Rome
country: Italy
facility: Ospedale Sant' Eugenio
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Sassari
country: Italy
facility: Ospedale Civile ASL 1
city: Trento
country: Italy
facility: Primario U.O. di Oncologia Medica
city: Turin
country: Italy
facility: Ospedale Ostetrico Ginecologica Sant Anna
city: Turin
country: Italy
facility: Universita di Torino
city: Kanagawa
country: Japan
facility: Tokai University School Of Medicine
city: Tokyo
country: Japan
facility: Tokyo Metropolitan - Komagome Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei Cancer Center at Yonsei University Medical Center
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Sittard
country: Netherlands
facility: Maasland Hospital
city: Utrecht
country: Netherlands
facility: Diakonessenhuis Utrecht
city: Gdansk
country: Poland
facility: Medical University of Gdansk
city: Gliwice
country: Poland
facility: Oncologic Center
city: Poznan
country: Poland
facility: Medical University
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
city: Coimbra
country: Portugal
facility: Instituto Portugues de Oncologia, Centro Regional de Coimbra
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra (HUC)
city: Coimbra
country: Portugal
facility: Maternidade Byssaia Barreto
city: Faro
country: Portugal
facility: Hospital Distrital De Faro
city: Lisboa
country: Portugal
facility: University Hospital of Santa Maria
city: Lisbon
country: Portugal
facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
city: Moscow
country: Russian Federation
facility: Moscow Oncology Hospital
city: Moscow
country: Russian Federation
facility: P.A. Hertzen Research Oncology Institute
city: Singapore
country: Singapore
facility: Johns Hopkins Singapore International Medical Centre
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Durban
country: South Africa
facility: Parklands Hospital
city: Johannesburg
country: South Africa
facility: Sandton Oncology Centre
city: Johannesburg
country: South Africa
facility: Medical Oncology Centre of Rosebank
city: Lynnwood
country: South Africa
facility: Pretoria - East Hospital
city: Alzira
country: Spain
facility: Hospital De La Ribera
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio de Granada
city: Guadalajara
country: Spain
facility: Hospital General Universitario De Guadalajara
city: Huelva
country: Spain
facility: Hospital Juan Ramon Jimenez
city: Jaen
country: Spain
facility: Hospital Cuidad de Jaen
city: La Coruna
country: Spain
facility: Centro Oncologico De Galicia Jose Antonio Quirogay Pineyro
city: La Laguna
country: Spain
facility: Hospital Universitario Canarias
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital de Gran Canaria Dr. Negrin
city: Las Palmas
country: Spain
facility: Hospital Insular de Gran Canaria
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Orense
country: Spain
facility: Complejo Hospitalario Santa Maria
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Sabadell
country: Spain
facility: Consorci Hospitalari del Parc Tauli
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Senora de la Candelaria
city: Sevilla
country: Spain
facility: Hospital Universidad Virgen Del Rocio
city: Toledo
country: Spain
facility: Hospital Virgen Del La Salud
city: Valencia
country: Spain
facility: Hospital General Universitario Valencia
city: Vigo Pontevedra
country: Spain
facility: Complexo Hospitalario Xeral de Vigo
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Linkoping
country: Sweden
facility: University Hospital of Linkoping
city: Malmo
country: Sweden
facility: University Hospital of Malmoe
city: Molndal
country: Sweden
facility: Sahlgrenska University Hospital - Molndal at Gothenburg University
city: Stockholm
country: Sweden
facility: Karolinska University Hospital - Huddinge
city: Umea
country: Sweden
facility: Umea Universitet
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Aarau
country: Switzerland
facility: Kantonspital Aarau
city: Basel
country: Switzerland
facility: Universitaetsspital-Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Chur
country: Switzerland
facility: Spitaeler Chur AG
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Mendrisio
country: Switzerland
facility: Ospedale Beata Vergine
city: St. Gallen
country: Switzerland
facility: Kantonsspital - St. Gallen
city: Zurich
country: Switzerland
facility: UniversitaetsSpital Zuerich
city: Bangkok
country: Thailand
facility: Chulalongkorn University Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bradford
country: United Kingdom
facility: Bradford Hospitals NHS Trust
state: England
city: Chelmsford, Essex
country: United Kingdom
facility: Broomfield Hospital
state: England
city: Epping Essex
country: United Kingdom
facility: Saint Margaret's Hospital
state: England
city: Grimsby
country: United Kingdom
facility: Diana Princess of Wales Hospital
state: England
city: Huddersfield, West Yorks
country: United Kingdom
facility: Huddersfield Royal Infirmary
state: England
city: Hull
country: United Kingdom
facility: Princess Royal Hospital
state: England
city: Leeds
country: United Kingdom
facility: Cookridge Hospital at Leeds Teaching Hospital NHS Trust
state: England
city: London
country: United Kingdom
facility: Imperial College of Medicine
state: England
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
state: England
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Northern Centre for Cancer Treatment at Newcastle General Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Cancer Research Centre at Weston Park Hospital
state: England
city: West Yorkshire
country: United Kingdom
facility: Airedale General Hospital
state: England
city: Westcliff-On-Sea
country: United Kingdom
facility: Southend NHS Trust Hospital
state: England
Study officials:
affiliation: Jules Bordet Institute
name: Martine J. Piccart-Gebhart, MD, PhD
role: STUDY_CHAIR
affiliation: Cancer Research Centre at Weston Park Hospital
name: Robert E. Coleman, MD, FRCP
role: STUDY_CHAIR
affiliation: British Columbia Cancer Agency
name: Karen A. Gelmon, MD
role: STUDY_CHAIR
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Kathleen I. Pritchard, MD
role: STUDY_CHAIR
affiliation: Ospedale Beata Vergine
name: Olivia Pagani, MD
role: STUDY_CHAIR
References:
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