Clinical trial NCT05840211: Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
Official title: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Locally Advanced or Unresectable Metastatic Breast Cancer
Stage IV Breast Cancer
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 654
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: The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).


Eligibility criteria: Key Inclusion Criteria:

* Able to understand and give written informed consent.
* Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site.
* Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy preferably from a locally recurrent or metastatic site.
* Documented evidence of HER2- status.
* Documented PD by computed tomography (CT) or magnetic resonance imaging during or after the most recent therapy per RECIST v1.1 criteria.
* Candidate for the first chemotherapy in the locally advanced or metastatic setting.
* Eligible for capecitabine, nab-paclitaxel, or paclitaxel.
* Individuals must have at least one of the following:

  * Disease progression on at least 2 or more previous lines of endocrine therapy (ET) with or without a targeted therapy in the metastatic setting.

    * Disease recurrence while on the first 24 months of starting adjuvant ET will be considered a line of therapy; these individuals will only require 1 line of ET in the metastatic setting.
  * Disease progression within 6 months of starting first-line ET with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor (if ineligible or if unable to access a CDK 4/6 inhibitor) in the metastatic setting.
  * Disease recurrence while on the first 24 months of starting adjuvant ET with CDK 4/6 inhibitor and if the individual is no longer a candidate for additional ET in the metastatic setting.
* Individuals may have received prior targeted therapies, including but not limited to PARP inhibitors (for those with germline BRCA1 or BRCA2 mutations), phosphatidylinositol 3-kinase (PI3K) inhibitors (for those with PIK3CA mutations), or mammalian target of rapamycin (mTOR) inhibitors. However, individuals can no longer be candidates for additional endocrine treatment with or without targeted therapies.
* Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.
* Demonstrates adequate organ function.
* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Key Exclusion Criteria:

* Progressive disease within 6 months of completing (neo)adjuvant chemotherapy.
* Locally advanced metastatic breast cancer (mBC) (Stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.
* Current enrollment in another clinical study and use of any investigational device or drug (drugs not marketed for any indication) either within 5 half-lives or 28 days prior to randomization, whichever is longer.

  * Use of investigational drugs in the category of Selective Estrogen Receptor Degraders are acceptable if last dose was longer than 14 days prior to randomization.
* Received any prior treatment (including antibody-drug conjugate (ADC)) containing a chemotherapeutic agent targeting topoisomerase I.
* Received any prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.
* Have an active second malignancy.
* Have an active serious infection requiring antibiotics.
* Have active hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Individuals positive for human immunodeficiency virus type 1/2 (HIV-1 or -2) with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
* Have a positive serum pregnancy test or are breastfeeding for individuals who are assigned female at birth.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
timeFrame: Up to approximately 29 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Until death, up to approximately 60 months
measure: Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
timeFrame: Until progression, up to approximately 60 months
measure: Change from Baseline in the Physical Functioning Domain Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) at Week 16
timeFrame: Baseline, Week 16
measure: Time to Deterioration in Version 3.0 EORTC-QLQ-C30 Scores
timeFrame: Up to approximately 60 months
measure: Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
timeFrame: Until progression or death, up to approximately 60 months
measure: Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1
timeFrame: Up to approximately 60 months
measure: Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1
timeFrame: Until progression or death, up to approximately 60 months
measure: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: First dose date up to 30 days post last dose, up to approximately 60 months
measure: Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities
timeFrame: First dose date up to 30 days post last dose, up to approximately 60 months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
state: Arizona
city: Los Angeles
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Institute
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
state: California
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: New Haven
country: United States
facility: Yale-New Haven Hospital-Yale Cancer Center
state: Connecticut
city: Altamonte Springs
country: United States
facility: Investigational Drug Services, AdventHealth Orlando
state: Florida
city: Brooksville
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Leesburg
country: United States
facility: Florida Cancer Specialist
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialist
state: Florida
city: Atlanta
country: United States
facility: Piedmont Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Georgia Cancer Specialist - Annex
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers
state: Georgia
city: Kansas City
country: United States
facility: The University of Kansas Hospital
state: Kansas
city: Baton Rouge
country: United States
facility: Hematology Oncology Clinic
state: Louisiana
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute
state: Missouri
city: Saint Louis
country: United States
facility: David C. Pratt Cancer Center
state: Missouri
city: East Brunswick
country: United States
facility: Astera Cancer Care
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Stefanie Spielman Comprehensive Breast Center
state: Ohio
city: Hershey
country: United States
facility: Penn State Cancer Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Womens of UPMC
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health - Upstate
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Fairfax
country: United States
facility: US Oncology Investigational Products Center (IPC)
state: Virginia
city: Norfolk
country: United States
facility: US Oncology Investigational Products Center (IPC)
state: Virginia
city: Auburn
country: United States
facility: MultiCare Regional Cancer Center - Auburn
state: Washington
city: Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Clinicas de Mar del Plata
city: C.a.b.a.
country: Argentina
facility: Instituto Alexander Fleming
city: Caba
country: Argentina
facility: Hospital Alemán
city: Cordoba
country: Argentina
facility: Centro Privado de RMI Rio Cuarto S.A.
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario
city: San Juan
country: Argentina
facility: CER San Juan Centro Polivalente de Asistencia e Investigación Clínica
city: Queensland
country: Australia
facility: Royal Brisbane and Women's Hospital
state: ME
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: GenesisCare North Shore (Oncology)
state: New South Wales
city: Auchenflower
country: Australia
facility: Icon Cancer Centre Wesley
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Hobart
country: Australia
facility: Icon Cancer Centre Hobart
state: Tasmania
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital (Western Health)
state: Victoria
city: Nedlands
country: Australia
facility: Breast Cancer Research Centre - WA
state: Western Australia
city: Innsbruck
country: Austria
facility: University Hospital Innsbruck
city: Salzburg
country: Austria
facility: Universitätsklinik für Innere Medizin 3 der PMU
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
city: Wien
country: Austria
facility: Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur Onkologie
city: Antwerpen
country: Belgium
facility: GZA Ziekenhuizen - Campus Sint-Augustinus
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuis Leuven
city: Namur
country: Belgium
facility: CHU UCL Namur-Site STE. Elisabeth
city: Fortaleza
country: Brazil
facility: Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará
city: Goiânia
country: Brazil
facility: Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica e Oncologia
city: Itajai
country: Brazil
facility: Catarina Pesquisa Clinica
city: Minas Gerais
country: Brazil
facility: Oncoclinicas do Brasil Servicos Medicos AS
city: Natal
country: Brazil
facility: Liga Norte-Rio-Grandense Contra o Câncer
city: Paraana
country: Brazil
facility: CIONC-Centro Integrado de Oncologia de Curitiba
city: Paraná
country: Brazil
facility: Hospital Erasto Gaertner
city: Pernambuco
country: Brazil
facility: IMIP - Instituto de Medicina Integral Professor Fernando Figueira
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre - HCPA
city: Porto Alegre
country: Brazil
facility: HGB - Hospital Giovanni Battista/Mãe de Deus Center
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
city: Rio de Janeiro
country: Brazil
facility: Instituto Americas
city: Rio Grande Do Sul
country: Brazil
facility: Clínica de Oncologia de Porto Alegre Ltda - CLINIONCO
city: Rio Grande Do Sul
country: Brazil
facility: Unidade de PesquisasClinicas em Oncologia - UPCO
city: Rio Grande Do Sul
country: Brazil
facility: Instituto do Câncer - Hospital São Vicente de Paulo
city: Santo Andre
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
city: São Paulo
country: Brazil
facility: Instituto Hemomed Oncologia e Hematologia
city: São Paulo
country: Brazil
facility: Clinica de pesquisa e centro de estudos em oncologia ginecológica e mamaria
city: Kelowna
country: Canada
facility: BC Cancer - Kelowna
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
city: Quebec
country: Canada
facility: CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
city: Toronto
country: Canada
facility: Humber River Hospital
city: Victoria
country: Canada
facility: BC Cancer-Victoria
city: Recoleta
country: Chile
facility: Centro de Investigacion Clinica Bradford Hill
city: Region Metropolitana
country: Chile
facility: Centro del Cancer UC
city: Santiago Region
country: Chile
facility: Centro de Oncología de Precisión (COP)
city: Temuco
country: Chile
facility: James Lind Centro de Investigacion del Cancer
city: Vina del Mar
country: Chile
facility: Oncocentro APYS
city: Anhui
country: China
facility: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Fujian
country: China
facility: Fujian Cancer Hospital
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Guangdong
country: China
facility: Sun Yat-Sen University Cancer Center
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital,Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Heilongjiang
country: China
facility: Harbin Medical University Cancer Hospital
city: Jiangsu
country: China
facility: Jiangsu Province Hospital
city: Jiangsu
country: China
facility: The First Affiliated Hospital of Soochow University
city: Jiangxi
country: China
facility: The Nanchang Third Hospital
city: Jilin Sheng
country: China
facility: The Second Hospital of Jilin University
city: Jinan
country: China
facility: Affiliated Cancer Hospital of Shandong First Medical University
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Ningxia Hui
country: China
facility: General Hospital of Ningxia Medical University
city: Qingdao
country: China
facility: The Affiliated Hospital Of Qingdao University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Zhejiang
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Brno
country: Czechia
facility: Fakultni Nemocnice Brno
city: Brno
country: Czechia
facility: Masaryk Memorial Cancer Institute
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Pardubice
country: Czechia
facility: Multiscan s.r.o
city: Prague 4
country: Czechia
facility: Fakultni nemocnice v Motole
city: Prague
country: Czechia
facility: Charles General University Hospital, Prague
city: Zlin
country: Czechia
facility: Krajska nemocnice Tomase Bati Zlin
city: Besancon
country: France
facility: CHU Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonié
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: Clinique Francois Chenieux
city: Loire Atlantique
country: France
facility: Ico René Gauducheau
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier Cedex 5
country: France
facility: Institut Regional du Cancer de Montpellier
city: Paris
country: France
facility: Institut Curie
city: Pierre-benite
country: France
facility: Centre Hospitalier Lyon-Sud
city: Plerin
country: France
facility: Hopital Privé des Cotes d'Armor
city: Rennes Cedex
country: France
facility: Centre Jean Bernard Service d'Oncologie Médicale
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Toulouse Cedex 9
country: France
facility: Institut Universitaire du Cancer de Toulouse Oncopole
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Baden-Württemberg
country: Germany
facility: Universitaetsklinikum Freiburg, Klinik fuer Frauenheilkunde
city: Bayern
country: Germany
facility: University Hospital rechts der Isar Technical University of Munich
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch
city: Bottrop
country: Germany
facility: Marienhospital Bottrop
city: Erlangen
country: Germany
facility: Universitätsklinik Erlangen
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Nationales Centrum für Tumorerkrankungen Heidelberg
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Munster
country: Germany
facility: Universitatsklinikum Munster
city: München
country: Germany
facility: LMU Klinikum der Universitat München
city: Tübingen
country: Germany
facility: Universitäts - Frauenklinik
city: Athens
country: Greece
facility: Alexandra General Hospital
city: Athens
country: Greece
facility: Attikon Hospital
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Patras
country: Greece
facility: University Hospital of Patras
city: Thessaloniki
country: Greece
facility: Bioclinic of Thessaloniki
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki
city: Hong Kong
country: Hong Kong
facility: Hong Kong Integrated Oncology Centre
city: New Territories
country: Hong Kong
facility: Prince of Wales Hospital
city: Pok Fu Lam
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ
city: Kecskemét
country: Hungary
facility: Bács-Kiskun Varmegyei Oktatokorhaz, Onkaradiologiai Kozpont
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz, Onkoradiologia
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
city: Haifa
country: Israel
facility: Oncology Institute Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Ancona AN
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - IRCCS
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola
city: Catania
country: Italy
facility: Humanitas Istituto Clinico Catanese
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini
city: Genova GE
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Milano
country: Italy
facility: Fondazione IRCCS San Raffaele del Monte Tabor
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IOV
city: Rionero in Vulture
country: Italy
facility: Irccs Crob
city: Roma
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital
city: Aoba-ku
country: Japan
facility: Tohoku University Hospital
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
city: Chuo-ku
country: Japan
facility: Osaka Prefectural Hospital Organization Osaka International Cancer Institute
city: Ehime
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Kagoshima-shi
country: Japan
facility: Social Medical Corporation Hakuaikai Sagara Hospital
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
city: Koto-Ku
country: Japan
facility: Cancer Institute Hospital of JFCR
city: Kumamoto- shi
country: Japan
facility: Kumamoto University Hospital
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital
city: Minami-ku
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Naka-ku
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
city: Nishinomiya-shi
country: Japan
facility: Hyogo Medical University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
city: Shinjuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Tokyo
country: Japan
facility: Showa University Hospital
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
city: Gangnam-Gu
country: Korea, Republic of
facility: Samsung Medical Center
city: Goyang-si Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Gyeongsangbuk-do
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seongnam
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: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Putrajaya
country: Malaysia
facility: Institut Kanser Negara
city: Cancún
country: Mexico
facility: Centro de Investigacion y Avances Medicos Especializados
city: Mexico City
country: Mexico
facility: COI Centro Oncologico Internacional S.A.P.I. de C.V.
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. José Eleuterio González
city: México
country: Mexico
facility: FUCAM
city: Puebla
country: Mexico
facility: Clinica Integral Internacional de Oncologia S de RL de CV
city: San Pedro Garza García
country: Mexico
facility: Centro Medico Zambrano Hellion
city: Yucatán
country: Mexico
facility: Centro de Atención e Investigación Clínica en Oncología
city: Gdansk
country: Poland
facility: Copemicus Podmiot Leczniczy Wojewodzkie Centrum Okologii w Gdansku
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.o
city: Lodz
country: Poland
facility: Instytut MSF Sp. z o.o.
city: Lublin
country: Poland
facility: Wojewodzki Szpital Specjalistyczny lm. Stefana Kardynala Wyszynsklego SPZOZ w Lublinie
city: Warszawa
country: Poland
facility: LUX MED Onkologia Sp. Zo.o.
city: Warszawa
country: Poland
facility: Maria Sklodowska - Curie Institute of Oncology
city: Braga
country: Portugal
facility: Centro Clinico Academico - Hospital de Braga
city: Guimarães
country: Portugal
facility: Hospital da Senhora da Oliveira Guimaraes
city: Lisbon
country: Portugal
facility: Centro Hospitalar de Lisboa Central, E.P.E . - Hospital de Santo Antonio dos Capuchos
city: Lisbon
country: Portugal
facility: Fundacao Champalimaud
city: Lisbon
country: Portugal
facility: Centro Hospitalar Lisboa Norte, EPE
city: Matosinhos
country: Portugal
facility: Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Gauteng
country: South Africa
facility: Wilgers Oncology Centre
city: Johannesburg
country: South Africa
facility: Wits Clinical Research
city: Johannesburg
country: South Africa
facility: The Medical Oncology Centre of Rosebank
city: Kraaifontein
country: South Africa
facility: Cape Town Oncology Trials
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Bilbo
country: Spain
facility: Hospital de Basurto
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Elche
country: Spain
facility: Hospital General Universitario De Elche
city: Jaen
country: Spain
facility: Hospital Universitario de Jaen
city: Madrid
country: Spain
facility: Hospital Beata María Ana
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela - CHUS
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Instituto Valenciano De Oncologia (IVO)
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital, Liouying
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
city: London
country: United Kingdom
facility: Barts Cancer Institute
city: London
country: United Kingdom
facility: University College London Hospitals
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: