Clinical trial NCT04546009: A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
Official title: A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2020-09-11
Enrollment: 992
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 Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment
* Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
* Documented ER-positive tumor and HER2-negative tumor, assessed locally
* Patients who have bilateral breast cancers which are both ER-positive and HER2-negative can be included in the study because the metastases are suitably targeted by the study treatments. If patients have bilateral tumors which are of different biomarker status, then proof of the ER and HER2 status of the metastases is required for study entry
* No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease
* Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months
* Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
* Eastern Cooperative Oncology Group Performance Status 0-1
* Adequate organ function

Exclusion Criteria:

* Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor
* Prior treatment with a selective estrogen receptor degrader (SERD)
* Treatment with any investigational therapy within 28 days prior to study treatment
* Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
* Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
* Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
* Pregnant or breastfeeding

Primary outcomes:
measure: Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1
timeFrame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 78 months)
Secondary outcomes:
measure: Overall Survival
timeFrame: From randomization to death from any cause (up to 78 months)
measure: Objective Response Rate, as Determined by the Investigator According to RECIST v1.1
timeFrame: From randomization until disease progression or death (up to 78 months)
measure: Duration of Response, as Determined by the Investigator According to RECIST v1.1
timeFrame: From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to 78 months)
measure: Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1
timeFrame: From randomization until disease progression or death (up to 78 months)
measure: Time to Confirmed Deterioration in Pain Level, Defined as the Time to First Documented ≥2-Point Increase from Baseline in the 'Worst Pain' Item from the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire
timeFrame: From Baseline until treatment discontinuation (up to 78 months)
measure: Time to Confirmed Deterioration in Pain Presence and Interference, Defined as the Time to First Documented ≥10-Point Increase from Baseline in the EORTC QLQ-C30 Linearly Transformed Pain Scale Score
timeFrame: From Baseline until treatment discontinuation (up to 78 months)
measure: Time to Confirmed Deterioration in Physical Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Physical Functioning Scale Score
timeFrame: From Baseline until treatment discontinuation (up to 78 months)
measure: Time to Confirmed Deterioration in Role Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Role Functioning Scale Score
timeFrame: From Baseline until treatment discontinuation (up to 78 months)
measure: Time to Confirmed Deterioration in Global Health Status and Quality of Life (GHS/QoL), Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed GHS/QoL Scale Score
timeFrame: From Baseline until treatment discontinuation (up to 78 months)
measure: Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0)
timeFrame: From treatment initiation until 30 days after the final dose of study treatment (up to 78 months)
measure: Number of Participants with Vital Sign Abnormalities Over the Course of the Study
timeFrame: Baseline, Days 1 and 15 of Cycles 1 and 2, and Day 1 of each cycle thereafter until treatment discontinuation (1 cycle is 28 days)
measure: Plasma Concentration of Giredestrant at Specified Timepoints
timeFrame: Days 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 8, and 16 (1 cycle is 28 days)
measure: Plasma Concentration of Palbociclib at Specified Timepoints
timeFrame: Days 1 and 15 of Cycle 1 (1 cycle is 28 days)
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Orange Coast Memorial Medical Center
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente - San Leandro Medical Center
state: California
city: Stanford
country: United States
facility: Stanford Univ Medical Center
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente - Vallejo
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente - Walnut Creek
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - Fort Myers (Broadway)
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Cancer Ctr
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Saint Petersburg
country: United States
facility: SCRI Florida Cancer Specialists North
state: Florida
city: Tallahassee
country: United States
facility: SCRI Florida Cancer Specialists PAN
state: Florida
city: Honolulu
country: United States
facility: Kaiser Permanente - Moanalua Medical Center
state: Hawaii
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Silver Spring
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Kansas City
country: United States
facility: HCA Midwest Division
state: Missouri
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center Basking Ridge
state: New Jersey
city: East Brunswick
country: United States
facility: Astera Cancer Care East Brunswick
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering - Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Cancer Center at Bergen
state: New Jersey
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Commack
country: United States
facility: MSKCC @ Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Cancer Center at Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Cancer Center at Nassau
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Ctr
state: Oregon
city: Charleston
country: United States
facility: Roper St. Francis Healthcare
state: South Carolina
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute / Tennessee Oncology
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - DFW
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders - Fort Worth
state: Texas
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Fairfax
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Hospital de Onc Angel Roffo
city: Buenos Aires
country: Argentina
facility: Fundación CENIT para la Investigación en Neurociencias
city: Cap fed
country: Argentina
facility: Organización medica de Investi
city: Ciudad Autonoma Bs As
country: Argentina
facility: Hospital Britanico
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario
city: Vicente López
country: Argentina
facility: CEMER Centro Medico de Enfermedades Respiratorias
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre-East Melbourne
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital - Medical Oncology
state: Western Australia
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg, LKH
city: Steyr
country: Austria
facility: A.Ö. LHK
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Hasselt
country: Belgium
facility: Jessa Zkh (Campus Virga Jesse)
city: Salvador
country: Brazil
facility: Hospital Sao Rafael - HSR
state: Bahia
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge
state: Goiás
city: Recife
country: Brazil
facility: Hospital do Cancer de Pernambuco - HCP
state: Pernambuco
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 Sao Lucas - PUCRS
state: Rio Grande Do Sul
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto
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: Beneficencia Portuguesa de Sao Paulo
state: São Paulo
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Center-Calgary
state: Alberta
city: Surrey
country: Canada
facility: BC Cancer ? Surrey
state: British Columbia
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Brampton
country: Canada
facility: William Osler Health System Brampton Civic Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: Universite de Montreal - Hopital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l?Université de Montréal (CHUM)
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Quebec City
country: Canada
facility: Hopital du Saint Sacrement
state: Quebec
city: Anyang City
country: China
facility: Anyang Tumor Hosptial
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Bengbu City
country: China
facility: the First Affiliated Hospital of Bengbu Medical College
city: Changchun City
country: China
facility: The First Hospital of Jilin University
city: Changsha City
country: China
facility: Hunan Cancer Hospital
city: Fujian
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
city: Guangzhou
country: China
facility: Sun Yet-sen University Cancer Center
city: Hangzhou City
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Nanning
country: China
facility: Guangxi Cancer Hospital of Guangxi Medical University
city: ShenYang
country: China
facility: Shengjing Hospital of China Medical University
city: Shenyang
country: China
facility: Liaoning cancer Hospital & Institute
city: Xi'an City
country: China
facility: The First Affiliated Hospital of Xian Jiao Tong University
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Naestved
country: Denmark
facility: Sjællands Universitetshospital, Næstved
city: Odense C
country: Denmark
facility: Odense Universitetshospital, Onkologisk Afdeling R
city: Angers
country: France
facility: ICO Paul Papin
city: Bayonne
country: France
facility: Centre Hospitalier de La Cote Basque
city: La Roche Sur Yon
country: France
facility: Chd de Vendee
city: Montpellier
country: France
facility: Institut régional du Cancer Montpellier
city: Poitiers
country: France
facility: Chu La Miletrie
city: Reims CEDEX
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Saint-Priest en Jarez
country: France
facility: ICL
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis Vautrin
city: Berlin
country: Germany
facility: Ambulantes Tumorzentrum Spandau
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Georgsmarienhütte
country: Germany
facility: Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
city: Göttingen
country: Germany
facility: Dres.Andreas Ammon und Dirk Meyer
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf, Studien GbR
city: Hannover
country: Germany
facility: Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
city: Heidelberg
country: Germany
facility: Nationales Centrum für Tumorerkrankungen (NCT)
city: Koblenz
country: Germany
facility: Praxis Köppler, Heymann, Weide, Thomalla
city: Langen
country: Germany
facility: Dres. Andreas Köhler und Roswitha Fuchs
city: Leipzig
country: Germany
facility: St. Elisabeth-Krankenhaus, Senologie/Brustzentrum
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: München
country: Germany
facility: Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
city: Ravensburg
country: Germany
facility: MVZ für Hämatologie und Onkologie Ravensburg GmBH
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH
city: Troisdorf
country: Germany
facility: Dres. Helmut Forstbauer, Carsten Ziske und Kollegen
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen
city: Athens
country: Greece
facility: Anticancer Hospital Ag Savas
city: Athens
country: Greece
facility: Anticancer Hospital Ag. Savas
city: Thessaloniki
country: Greece
facility: Euromedical General Clinic of Thessaloniki
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Honvédelmi Minisztérium Állami Egészségügyi Központ;Onkológiai Osztály
city: Budapest
country: Hungary
facility: Budapesti Uzsoki Utcai Kórház
city: Petah Tiqwa
country: Israel
facility: Davidof Center - Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Ctr
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
state: Emilia-Romagna
city: Roma
country: Italy
facility: IRCCS Istituto Regina Elena (IFO)
state: Lazio
city: Brescia
country: Italy
facility: Az. Osp. Spedali Civili
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Monza
country: Italy
facility: Asst Di Monza
state: Lombardia
city: Misterbianco (CT)
country: Italy
facility: Humanitas Centro Catanese Di Oncologia
state: Sicilia
city: Livorno
country: Italy
facility: Ospedale Civile - Livorno
state: Toscana
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l?Oncologia (IRCCS)
state: Trentino-Alto Adige
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
state: Veneto
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto - IRCCS
state: Veneto
city: Vicenza
country: Italy
facility: Azienda ULSS 8 Berica
state: Veneto
city: Aichi
country: Japan
facility: Nagoya University Hospital
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hokkaido
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
city: Hyogo
country: Japan
facility: Hyogo Cancer Center
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital
city: Kagoshima
country: Japan
facility: Sagara Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Miyagi
country: Japan
facility: Fukushima Medical University Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okinawa
country: Japan
facility: Naha-nishi Clinic
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Tokyo
country: Japan
facility: Showa University Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
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: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hosiptal
city: CD Mexico
country: Mexico
facility: Health Pharma Professional Research
state: Mexico CITY (federal District)
city: Cdmx
country: Mexico
facility: Centro Medico Dalinde
state: Mexico CITY (federal District)
city: Monterrey
country: Mexico
facility: Filios Alta Medicina
state: Nuevo LEON
city: Oaxaca de Juárez
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
state: Oaxaca
city: San Luis Potosí
country: Mexico
facility: Oncologico Potosino
state: SAN LUIS Potosi
city: Morelia
country: Mexico
facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazón (SOMECO)
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Lima
country: Peru
facility: Oncosalud Sac
city: Lima
country: Peru
facility: Instituto Peruano de Oncología y Radioterapia
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: San Isidro
country: Peru
facility: Clinica Ricardo Palma
city: Trujillo
country: Peru
facility: Instituto Regional de Enfermedades Neoplasicas - IREN Norte
city: Gda?sk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Gdynia
country: Poland
facility: Szpital Morski im. PCK
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 da Luz
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte
city: Porto
country: Portugal
facility: IPO do Porto
city: Saransk
country: Russian Federation
facility: Respublikanskiy Onkologicheskiy Dispanser
state: Mordovija
city: Moskva
country: Russian Federation
facility: SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
state: Moskovskaja Oblast
city: Podolsk
country: Russian Federation
facility: Podolsk City Clinical Hospital
state: Moskovskaja Oblast
city: Ryazan
country: Russian Federation
facility: Ryazan Regional clinical oncology dispensary
state: Rjazan
city: Saint Petersburg
country: Russian Federation
facility: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
state: Sankt Petersburg
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk region oncology dispensary
city: Samara
country: Russian Federation
facility: Multidisciplinary clinic Reaviz
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Oncology Hospital
city: L' Hospitalet DE Llobregat
country: Spain
facility: Hospital Duran i Reynals
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: San Sebastian
country: Spain
facility: Hospital de Donostia
state: Guipuzcoa
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron de Madrid
state: Madrid
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus - Grupo Quironsalud
city: Barcelona
country: Spain
facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona
city: La Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Centro Oncologico MD Anderson Internacional
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: HM Sanchinarro ? CIOCC
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung Uni Hospital
city: Taipei
country: Taiwan
facility: Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taoyuan Hsien
country: Taiwan
facility: Chang Gung Memorial Hosipital at Linkou
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital, Faculty of Medicine
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Chang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hosp
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
city: Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty
city: Istanbul
country: Turkey
facility: Medeniyet University Goztepe Training and Research Hospital.
city: Izmir
country: Turkey
facility: Katip Celebi University Ataturk Training and Research Hospital
city: Izmit
country: Turkey
facility: Kocaeli University Faculty of Medicine
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
city: Samsun
country: Turkey
facility: 19 Mayis University Medical Faculty
city: Dnipropetrovsk
country: Ukraine
facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council
state: Katerynoslav Governorate
city: Kharkiv
country: Ukraine
facility: SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU
state: Kharkiv Governorate
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Oncology Center
city: Kryvyi Rih
country: Ukraine
facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council
city: Sumy
country: Ukraine
facility: Sumy Regional Clinical Onc Ctr
city: Uzhhorod
country: Ukraine
facility: Uzhgorod Central City Clinical Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Guys & St Thomas Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hosp NHS Fnd
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
city: Peterborough
country: United Kingdom
facility: Peterborough City Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hosp NHS Fnd
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: