Clinical trial NCT06065748: A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
Official title: A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
Keywords: oral Selective Estrogen Receptor Degrader (SERD)
CDK4/6 inhibitor (CDK4/6i)
ESR1 mutation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2023-10-04
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.


Eligibility criteria: Inclusion Criteria:

* Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
* Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)
* Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
* Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after \>/=12 months or off-treatment within 12 months of completion. Prior use of adjuvant CDK4/6i is allowed (if relapse occurred \>/=12 months since completion).
* No prior systemic anti-cancer therapy for advanced disease
* Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
* For pre/perimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment

Exclusion Criteria:

* Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
* Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
* Active cardiac disease or history of cardiac dysfunction
* Clinically significant history of liver disease

Primary outcomes:
measure: Progression-Free Survival (PFS) in the ESR1 mutation (ESR1m) Subgroup
timeFrame: From randomization to first occurrence of progressive disease (PD) or death (up to 5 years)
measure: PFS in the Full Analysis Set (FAS) Population
timeFrame: From randomization to first occurrence of PD or death (up to 5 years)
Secondary outcomes:
measure: PFS in the ESR1 no-mutation-detected (ESR1nmd) Subgroup
timeFrame: From randomization to first occurrence of PD or death (up to 5 years)
measure: Overall Survival (OS)
timeFrame: From randomization until death from any cause (up to 5 years)
measure: Confirmed Objective Response Rate (cORR)
timeFrame: From randomization until treatment discontinuation (up to 5 years)
measure: Duration of Response (DOR)
timeFrame: From the first occurrence of a documented objective response to PD or death (up to 5 years)
measure: Clinical Benefit Rate (CBR)
timeFrame: From randomization until treatment discontinuation (up to 5 years)
measure: Time to Chemotherapy
timeFrame: From randomization until the start of chemotherapy or death (up to 5 years)
measure: Time to Confirmed Deterioration (TTCD) in Pain Severity
timeFrame: From randomization until end of follow-up (up to 5 years)
measure: TTCD in Pain Presence and Interference
timeFrame: From randomization until end of follow-up (up to 5 years)
measure: TTCD in Physical Functioning
timeFrame: From randomization until end of follow-up (up to 5 years)
measure: TTCD in Role Functioning
timeFrame: From randomization until end of follow-up (up to 5 years)
measure: TTCD in Global Health Status/Quality of Life
timeFrame: From randomization until end of follow-up (up to 5 years)
measure: Incidence and Severity of Adverse Events
timeFrame: From Baseline until 28 days after the final dose of study treatment (up to 5 years)
measure: Number of Participants with Vital Sign Abnormalities Over the Course of the Study
timeFrame: From Baseline until 28 days after the final dose of study treatment (up to 5 years)
measure: Number of Participants with Clinical Laboratory Test Abnormalities for Hematology and Biochemistry Parameters Over the Course of the Study
timeFrame: From Baseline until 28 days after the final dose of study treatment (up to 5 years)
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Southern Cancer Center
state: Alabama
city: Auburn
country: United States
facility: Sutter Auburn Faith Hospital
state: California
city: Glendale
country: United States
facility: La Hematology Oncology Medical Group
state: California
city: Greenbrae
country: United States
facility: Marin Cancer Care Inc
state: California
city: Harbor City
country: United States
facility: Kaiser Permanente - Harbor City
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Newport Beach
country: United States
facility: USC Norris Cancer Center
state: California
city: Roseville
country: United States
facility: Sutter Medical Group, Roseville Clinic
state: California
city: Sacramento
country: United States
facility: Sutter Health Medical Center
state: California
city: Torrance
country: United States
facility: The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
state: California
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Washington
country: United States
facility: MedStar Washington Hosp Center
state: District of Columbia
city: Altamonte Springs
country: United States
facility: AdventHealth Altamonte
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - Fort Myers (Gladiolus Dr)
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Comprehensive Hematology Oncology
state: Florida
city: Tampa
country: United States
facility: Florida Cancer Specialists - Tampa
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - EAST - SCRI - PPDS
state: Florida
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Des Moines
country: United States
facility: Mission Cancer + Blood - IMMC
state: Iowa
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: Baptist Health Hamburg
state: Kentucky
city: Louisville
country: United States
facility: Baptist Health Louisville
state: Kentucky
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Annapolis
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Frederick
country: United States
facility: Frederick Health Hospital
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Kansas City
country: United States
facility: HCA Midwest Division
state: Missouri
city: O'Fallon
country: United States
facility: Cancer Care Center of O'Fallon
state: Missouri
city: Omaha
country: United States
facility: Oncology Hematology West - Legacy
state: Nebraska
city: East Brunswick
country: United States
facility: Astera Cancer Care East Brunswick
state: New Jersey
city: Pennington
country: United States
facility: Capital Health Regional Medical Center
state: New Jersey
city: Jamaica
country: United States
facility: Queens Hospital Cancer Center
state: New York
city: Raleigh
country: United States
facility: Duke Women Cancer Care
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Medford
country: United States
facility: Asante Rogue Regional Medical Center
state: Oregon
city: Bensalem
country: United States
facility: Alliance Cancer Specialists
state: Pennsylvania
city: Lancaster
country: United States
facility: Ann B. Barshinger Cancer Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit
state: Pennsylvania
city: York
country: United States
facility: WellSpan Oncology Research
state: Pennsylvania
city: Providence
country: United States
facility: Brown University Health
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Aberdeen
country: United States
facility: Avera Cancer Institute - Aberdeen
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: JPS Oncology & Infusion Center
state: Texas
city: Irving
country: United States
facility: Texas Oncology - DFW
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University - Massey Cancer Center
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Hospitals Inc
state: West Virginia
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora St Lukes Medical Center
state: Wisconsin
city: Buenos aires
country: Argentina
facility: Inst. de Oncologia Angel H. Roffo
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Fundación CENIT para la Investigación en Neurociencias
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Centro Oncologico Korben
city: Cordoba
country: Argentina
facility: Sanatorio Allende
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (CORI)
city: Recoleta
country: Argentina
facility: Hospital Alemán
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario
city: Rosario
country: Argentina
facility: Sanatorio Parque S.A.
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
city: San Juan
country: Argentina
facility: Centro Oncológico de Excelencia
city: Frenchs Forest
country: Australia
facility: Northern Beaches Hospital
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: North Sydney
country: Australia
facility: Mater Hospital
state: New South Wales
city: Sippy Downs
country: Australia
facility: University of the Sunshine Coast
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Misericordiae Limited
state: Queensland
city: Adelaide
country: Australia
facility: Cancer Research SA
state: South Australia
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Warrnambool
country: Australia
facility: South West Healthcare
state: Victoria
city: Graz
country: Austria
facility: Lkh-Univ. Klinikum Graz
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Linz
country: Austria
facility: Ordensklinikum Linz Barmherzige Schwestern
city: Steyr
country: Austria
facility: Oö. Gesundheits- und Spitals-AG/LKH Steyr
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Namur
country: Belgium
facility: Clinique Ste-Elisabeth
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk
city: Salvador
country: Brazil
facility: Obras Sociais Irma Dulce - Osid
state: Bahia
city: Fortaleza
country: Brazil
facility: Crio - Centro Regional Integrado de Oncologia
state: Ceará
city: Brasilia
country: Brazil
facility: Hospital Sírio-Libanês
state: Distrito Federal
city: Vitoria
country: Brazil
facility: CEDOES - Diagnóstico e Pesquisa
state: Espírito Santo
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge
state: Goiás
city: Sao Luis
country: Brazil
facility: Hospital Sao Domingos
state: Maranhão
city: Recife
country: Brazil
facility: Hospital do Cancer de Pernambuco - HCP
state: Pernambuco
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericordia de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: São Paulo
city: Jau
country: Brazil
facility: Hospital Amaral Carvalho
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Sírio-Libanês
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital A. C. Camargo
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Chicoutimi
country: Canada
facility: CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital
state: Quebec
city: Levis
country: Canada
facility: CISSS Chaudière-Appalaches
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre - Glen Site
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Québec - Hôpital du Saint-Sacrement
state: Quebec
city: Saint-jerome
country: Canada
facility: Hopital regional de saint jerome
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Centre hospitalier regional de Trois-Rivieres
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Providencia
country: Chile
facility: Oncovida
city: Puerto Montt
country: Chile
facility: Clínica Puerto Montt
city: Santiago
country: Chile
facility: Centro De Cancer Universidad Catolica
city: Santiago
country: Chile
facility: Instituto Nacional del Cancer
city: Santiago
country: Chile
facility: Icegclinic
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changchun City
country: China
facility: the First Hospital of Jilin University
city: Changsha CITY
country: China
facility: Hunan Cancer Hospital
city: Chengdu City
country: China
facility: West China Hospital of Sichuan University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Chongqing
country: China
facility: The First Affiliated Hospital, Chongqing Medical University
city: Fuzhou City
country: China
facility: Fujian Medical University Union Hospital
city: Fuzhou City
country: China
facility: No. 900 Hospital (Fuzhou General Hospital)
city: Guangzhou City
country: China
facility: Cancer Center, Sun Yat-sen University of Medical Sciences
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University College
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Jinan City
country: China
facility: Jinan Central Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Kunming City
country: China
facility: The First People's Hospital of Yunnan Province
city: Luoyang
country: China
facility: The First Affiliated Hospital to Henan University of Science and Technology
city: Nanning
country: China
facility: Guangxi Cancer Hospital of Guangxi Medical University
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Taiyuan City
country: China
facility: Shanxi Province Cancer Hospital
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Urumqi
country: China
facility: The Tumor Hospital of Xinjiang Medical University
city: Wuhan City
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Xi'an City
country: China
facility: The Second Affiliated Hospital of Xi'an Jiao Tong University
city: Xian
country: China
facility: Xi'an International Medical Center Hospital
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Bogota, D.C.
country: Colombia
facility: Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
city: Cali
country: Colombia
facility: IPS Salud SURA Chipichape Cali
city: Monteria
country: Colombia
facility: Oncomedica S.A.
city: Valledupar
country: Colombia
facility: Sociedad de Oncología y hematología del Cesar Ltda
city: San José
country: Costa Rica
facility: Clinica CIMCA
city: San José
country: Costa Rica
facility: ICIMED Instituto de Investigación en Ciencias Médicas
city: San José
country: Costa Rica
facility: Proclinical Pharma
city: Kuopio
country: Finland
facility: Kuopio Uni Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Angers
country: France
facility: ICO Paul Papin
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Besancon
country: France
facility: Hopital Jean Minjoz
city: Caen
country: France
facility: Centre Francois Baclesse
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: La Rochelle
country: France
facility: Centre Hospitalier Saint Louis
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Montpellier
country: France
facility: Centre Cancerologie Grand Montpellier
city: Reims CEDEX
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Toulouse
country: France
facility: IUCT Oncopole
city: Villejuif
country: France
facility: Gustave Roussy
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie
city: Deggendorf
country: Germany
facility: DONAU ISAR Klinikum Deggendorf
city: Düsseldorf
country: Germany
facility: Gynonco Düsseldorf, MVZ Medical Center GmbH
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
city: Freiburg
country: Germany
facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
city: Heidelberg
country: Germany
facility: Nationales Centrum für Tumorerkrankungen (NCT)
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Koeln
country: Germany
facility: St. Elisabeth Krankenhaus Köln GmbH
city: Muenchen
country: Germany
facility: Rotkreuzklinikum München
city: Mönchengladbach
country: Germany
facility: Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
city: Athens
country: Greece
facility: Anticancer Hospital Ag. Savas
city: Athina
country: Greece
facility: Aretaieio Hospital of Athens
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Patras
country: Greece
facility: University Hospital of Patras Medical Oncology
city: Ciudad de Guatemala
country: Guatemala
facility: Celan S.A.
city: Ciudad de Guatemala
country: Guatemala
facility: INTEGRA Cancer Institute
city: Ciudad de Guatemala
country: Guatemala
facility: Onco Go, S.A.
city: ciudad de Guatemala
country: Guatemala
facility: Medi-k
city: Guatemala City
country: Guatemala
facility: Grupo Angeles
city: Guatemala
country: Guatemala
facility: Oncomedica
city: Salcajá
country: Guatemala
facility: Centro Medico Integral de Cancerologia CEMIC
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Kecskemét
country: Hungary
facility: Bács-Kiskun Vármegyei Oktatókórház
city: Miskolc
country: Hungary
facility: B-A-Z Vármegyei Központi Kórház és Egyetemi Oktatókórház
city: Salgótarján
country: Hungary
facility: Nograd Varmegyei Szent Lazar Korhaz
city: New Delhi
country: India
facility: Max Super Speciality Hospital
state: Delhi
city: Banglore
country: India
facility: HealthCare Global Enterprises Limited
state: Karnataka
city: Kozhikode
country: India
facility: MVR Cancer Centre and Research Institute
state: Kerala
city: Trivandrum
country: India
facility: Regional Cancer Centre
state: Kerala
city: Mumbai
country: India
facility: Sir H. N. Reliance Foundation Hospital and Research Centre
state: Maharashtra
city: Pune
country: India
facility: Grant Medical Foundation, Ruby Hall Clinic
state: Maharashtra
city: Thane
country: India
facility: Sunact Cancer Institute
state: Maharashtra
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Hospital
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba MC
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
city: Avellino
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
state: Campania
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
state: Campania
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
state: Emilia-Romagna
city: Meldola
country: Italy
facility: I.R.S.T Srl IRCCS
state: Emilia-Romagna
city: Parma
country: Italy
facility: A.O. Universitaria Di Parma
state: Emilia-Romagna
city: Aviano (PN)
country: Italy
facility: RCCS - Centro di Riferimento
state: Friuli-Venezia Giulia
city: Udine
country: Italy
facility: A.O. Universitaria S. Maria Della Misericordia Di Udine
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
state: Lazio
city: Roma
country: Italy
facility: Università Campus Bio-Medico di Roma
state: Lazio
city: Bergamo
country: Italy
facility: Asst Papa Giovanni XXIII
state: Lombardia
city: Brescia
country: Italy
facility: Asst Degli Spedali Civili Di Brescia
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int)
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: Macerata
country: Italy
facility: Ospedale Di Macerata
state: Marche
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità
state: Piemonte
city: Brindisi
country: Italy
facility: Presidio Ospedaliero di Summa-Perrino
state: Puglia
city: Misterbianco (CT)
country: Italy
facility: Humanitas Centro Catanese Di Oncologia
state: Sicilia
city: Florence
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto - IRCCS
state: Veneto
city: Nairobi
country: Kenya
facility: University of Nairobi - Institute of Tropical and Infectious Diseases
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hosiptal
city: Guadalajara
country: Mexico
facility: Panamerican Clinical Research S.A de C.V.
state: Jalisco
city: Guadalajara
country: Mexico
facility: RENATI INNOVATION S.A.P.I. de C.V
state: Jalisco
city: Ciudad de México
country: Mexico
facility: Productos y Servicios Oncologicos Acacias SA de CV
state: Mexico CITY (federal District)
city: Mexico City
country: Mexico
facility: Centro Oncológico Hematológico Roma
state: Mexico CITY (federal District)
city: Monterrey
country: Mexico
facility: Hospital Zambrano Hellion TecSalud
state: Nuevo LEON
city: Oaxaca de Juárez
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
state: Oaxaca
city: Queréaro
country: Mexico
facility: PanAmerican Clinical Research, Querétaro
state: Queretaro
city: Mexico City
country: Mexico
facility: CENEIT Oncologicos
city: Mexico City
country: Mexico
facility: Centro Medico Dalinde
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Palmerston North
country: New Zealand
facility: Palmerston North Hospital
city: Whangarei
country: New Zealand
facility: Whangarei Hospital
city: Arequipa
country: Peru
facility: Centro Medico Monte Carmelo
city: Lima
country: Peru
facility: Clínica Santa Beatriz
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza
city: Lima
country: Peru
facility: Oncosalud Sac
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Lima
country: Peru
facility: Clinica Internacional, Sede San Borja
city: Lima
country: Peru
facility: Instituto Peruano de Oncología y Radioterapia
city: Trujillo
country: Peru
facility: Clinica Peruana Americana
city: ?ód?
country: Poland
facility: Instytut "Centrum Zdrowia Matki Polki"
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
city: Gdynia
country: Poland
facility: Szpital Morski Im. Pck
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii Odzia? w Gliwicach
city: Kielce
country: Poland
facility: ?wi?tokrzyskie Centrum Onkologii
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED, Roman Karaszewski
city: Koszalin
country: Poland
facility: Szpital Wojewódzki im. Miko?aja Kopernika
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki im. ?w. Jana Paw?a II
city: Szczecin
country: Poland
facility: Zachodniopomorskie Centrum Onkologii
city: Warszawa
country: Poland
facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
city: Coimbra
country: Portugal
facility: IPO de Coimbra
city: Lisboa
country: Portugal
facility: Hospital de S. Francisco Xavier
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Porto
country: Portugal
facility: IPO do Porto
city: Vila Nova de Gaia
country: Portugal
facility: CHVNG/E_Unidade 1
city: San Juan
country: Puerto Rico
facility: PanOncology Trials
city: Bucuresti
country: Romania
facility: Spitalul Clinic Filantropia
city: Cluj County
country: Romania
facility: Amethyst Cluj
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantul Nectarie
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Timisoara
country: Romania
facility: Centrul de Oncologie Oncohelp
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Singapore
country: Singapore
facility: Icon Cancer Centre Gleneagles
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
city: Cape Town
country: South Africa
facility: Cancercare Rondebosch Oncology
city: Port Elizabeth
country: South Africa
facility: Cancercare
city: Badalona
country: Spain
facility: Institut Catala d?Oncologia Hospital Germans Trias i Pujol
state: Barcelona
city: Sant Andreu de La Barca
country: Spain
facility: Vall d'Hebron Institute of Oncology (VHIO), Barcelona
state: Barcelona
city: Jerez de La Frontera
country: Spain
facility: Hospital de Jerez de la Frontera
state: Cadiz
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron de Madrid
state: Madrid
city: EL Palmar (EL Palmar)
country: Spain
facility: Hospital Universitario Virgen de La Arrixaca
state: Murcia
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
state: Pontevedra
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus - Grupo Quironsalud
city: Huelva
country: Spain
facility: Hospital Juan Ramon Jimenez
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
city: Madrid
country: Spain
facility: Centro Oncologico MD Anderson Internacional
city: Madrid
country: Spain
facility: Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
city: Hsinchu City
country: Taiwan
facility: Hsin-Chu Branch of National Taiwan University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei City
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taipei
country: Taiwan
facility: Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital
city: Xitun Dist.
country: Taiwan
facility: Veterans General Hospital - Taichung
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Bangkok
country: Thailand
facility: National Cancer Institute
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Lak Si
country: Thailand
facility: Chulabhorn Hospital
city: Muang Chiang MAI Delivery Branch 3
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital;Depart of Radiology
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
city: Ankara
country: Turkey
facility: Ankara City Hospital
city: Bakirkoy / Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
city: Izmir
country: Turkey
facility: Katip Celebi University Ataturk Training and Research Hospital
city: Kadiköy
country: Turkey
facility: Goztepe Prof.Dr. Suleyman Yalcin City Hospital
city: Mersin
country: Turkey
facility: Mersin City Education and Research Hospital
city: Samsun
country: Turkey
facility: Medikal Park Samsun
city: Sihhiye/Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: