Clinical trial NCT06105632: A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment
Official title: AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 2 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS AT LEAST 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY (FOURLIGHT-1)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Advanced or Metastatic Breast Cancer
Keywords: Estrogen receptor positive [ER(+)]
Human epidermal growth factor receptor 2 negative [HER(-)]
ER(+)/HER2(-)
Advanced Breast Cancer
Breast tumor
Breast cancer
fulvestrant
everolimus
exemestane
Partial Response+ (PR+)
Metastatic breast cancer
Hormone Therapy
Hormone positive breast cancer
Recurrent breast cancer
HR+
HER2-negative
Relapse
Recurrent
Second line treatment.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-10-27
Enrollment: 333
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 purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body.

This study is seeking female and male participants who:

* are 18 years of age or older;
* are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative;
* have advanced or metastatic breast cancer after taking other treatments before this study;
* have not taken or need to take medications that are not allowed by the study protocol;
* do not have any medical or mental conditions that may increase the risk of study participation.

Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant. Fulvestrant will be given as a shot into the muscle. The other half will take the study doctor's choice of treatment which can either be:

* Fulvestrant alone taken as shot into the muscle.
* Everolimus along with exemestane taken once daily by mouth.

This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctor's choice of treatment. This will help decide if the study medicine is safe and effective.

Participants will receive study treatment and/or will be in the study until:

* imaging scans (such as an MRI and/or CT) show that their cancer is getting worse.
* the study doctor thinks the participant is no longer benefitting from the study medicine.
* has side effects that become too severe. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take.
* the participant chooses to stop taking part.


Eligibility criteria: Inclusion Criteria:

* Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
* Documented estrogen receptor (ER) and/or progesterone receptor (PR)- positive tumor
* Documented HER2-negative tumor
* Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.
* Must have received CDK4/6i plus NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment.
* Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.

Exclusion Criteria:

* Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
* In visceral crisis at risk of immediately life-threatening complications in the short term.
* Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
* Prior treatment with any of the following:
* Everolimus or investigational anti-cancer agents in any setting
* Prior chemotherapy in the advanced setting
* Radiation within 2 weeks of randomization
* Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, other endocrine therapies, growth factors, chronic systemic corticosteroids, strong cytochrome P450 3A4/5 \[CYP3A4/5\] or uridine 5' diphosphate-glucuronosyltransferase 2B7 \[UGT2B7\] inhibitors and inducers, direct oral anticoagulants, proton pump inhibitors).
* Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

Primary outcomes:
measure: Progression-Free Survival (PFS) progression, as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: From Initiation up to 2 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Time from the date of randomization to the date of death due to any cause up to approximately 3 years
measure: OR by investigator per RECIST v1.1
timeFrame: Time From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression OR death whichever occurs first (up to approximately 2 years)
measure: Duration of Response (DOR) as defined by investigator per RECIST v1.1
timeFrame: From the date of the first objective response (every 8 weeks during the first 48 weeks and then every 12 week) up to approximately 2 years.
measure: Number of Participants With Clinical Benefit Response (CBR) by investigator per RECIST v1.1
timeFrame: From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years
measure: Number or Patients with Adverse Events (AEs) by Type
timeFrame: From screening until 28 days after the last dose, to approximately 3 years
measure: Number or Patients with AEs by Incidence
timeFrame: From screening until 28 days after the last dose, to approximately 3 years
measure: Number or Patients with AEs by Seriousness
timeFrame: From screening until 28 days after the last dose, to approximately 3 years
measure: Number or Patients with AEs by relationship to study interventions
timeFrame: From screening until 28 days after the last dose, to approximately 3 years
measure: Number of Participants With Abnormal Electrocardiogram (ECG)
timeFrame: From baseline to approximately 2 years
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: From screening until 28 days after the last dose to approximately 2 years
measure: EQ-5D-5L
timeFrame: Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc) and EoT. Each Cycle is 28 days.
measure: EORTC QLQ
timeFrame: Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc) and EoT. Each Cycle is 28 days.
measure: EORTC QLQ Breast Cancer Module 23 (BR23)
timeFrame: Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc) and EoT. Each Cycle is 28 days.
measure: Ctrough of PF-07220060
timeFrame: Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycle 3 (Day 1). Each Cycle is 28 days
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Rogers
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Berkeley
country: United States
facility: UCSF - John Muir Health Cancer Center Berkeley
state: California
city: Fremont
country: United States
facility: Washington Hospital Healthcare System
state: California
city: Irvine
country: United States
facility: Hoag Health Center Irvine
state: California
city: Irvine
country: United States
facility: Hoag Hospital Irvine
state: California
city: La Quinta
country: United States
facility: Eisenhower George and Julia Argyros Health Center
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: Los Angeles General Medical Center
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Palm Springs
country: United States
facility: Eisenhower Health Center at South Palm Canyon
state: California
city: Pasadena
country: United States
facility: Keck Medical Center of USC Pasadena
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital and Trauma Center
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center at Mission Bay
state: California
city: San Mateo
country: United States
facility: UCSF Cancer Center San Mateo
state: California
city: Torrance
country: United States
facility: Chronic Disease Clinical Research Center (CDCRC)
state: California
city: Torrance
country: United States
facility: Clinical and Translational Research Center
state: California
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
state: California
city: Torrance
country: United States
facility: Diagnostic and Wellness Center
state: California
city: Bridgeport
country: United States
facility: Saint Vincent's Medical Center (SVMC)
state: Connecticut
city: Danbury
country: United States
facility: Danbury Hospital
state: Connecticut
city: Hartford
country: United States
facility: Hartford Hospital (HH)
state: Connecticut
city: Meriden
country: United States
facility: MidState Medical Center (MMC)
state: Connecticut
city: New Britain
country: United States
facility: Hartford Healthcare
state: Connecticut
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Plainville
country: United States
facility: Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut, Medical Arts Center
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Savannah
country: United States
facility: Summit Cancer Care, PC
state: Georgia
city: Barrington
country: United States
facility: Advocate Good Shepherd Hospital
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Chicago
country: United States
facility: Advocate Illinois Masonic Medical Center
state: Illinois
city: Downers Grove
country: United States
facility: Advocate Good Samaritan Hospital
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Evanston
country: United States
facility: Ascension Illinois - Evanston Infusion Center
state: Illinois
city: Glenview
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Highland Park
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Libertyville
country: United States
facility: AMG Libertyville
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Skokie
country: United States
facility: Ascension Illinois-Skokie Infusion Center
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc.
state: Illinois
city: Bettendorf
country: United States
facility: University of Iowa Health Care Cancer Services Quad Cities
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Annapolis
country: United States
facility: Velocity Clinical Research
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Newton
country: United States
facility: Dana-Farber Cancer Institute - Chestnut Hill
state: Massachusetts
city: Jackson
country: United States
facility: The University of Mississippi Medical Center
state: Mississippi
city: Jackson
country: United States
facility: The University of Mississippi Medical Center
state: Mississippi
city: Billings
country: United States
facility: Intermountain Health St. Vincent Regional Hospital
state: Montana
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Reno
country: United States
facility: Cancer Care Specialists
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Poughkeepsie
country: United States
facility: Vassar Brothers Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Houston
country: United States
facility: Memorial Hermann Cancer Center
state: Texas
city: Round Rock
country: United States
facility: Baylor Scott & White Medical Center - Round Rock
state: Texas
city: Mechanicsville
country: United States
facility: Bon Secours Memorial Regional Medical Center
state: Virginia
city: Midlothian
country: United States
facility: Bon Secours St. Francis Medical Center
state: Virginia
city: Richmond
country: United States
facility: Bon Secours at St. Mary's Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Burlington
country: United States
facility: Aurora Health Center - Southern Lakes
state: Wisconsin
city: Grafton
country: United States
facility: Aurora Medical Centers - Grafton
state: Wisconsin
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Kenosha
country: United States
facility: Aurora Health Center - Kenosha
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Health Center Milwaukee - Good Hope
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora St Luke's Medical Center
state: Wisconsin
city: Summit
country: United States
facility: Aurora Medical Center - Summit
state: Wisconsin
city: Wauwatosa
country: United States
facility: Aurora Cancer CAre
state: Wisconsin
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CIPREC
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Caba
country: Argentina
facility: Fundación Cenit Para La Investigación En Neurociencias
state: Ciudad Autónoma DE Buenos Aires
city: Caba
country: Argentina
facility: Organizacion Medica de Investigacion
state: Ciudad Autónoma DE Buenos Aires
city: Caba
country: Argentina
facility: Hospital Británico de Buenos Aires
state: Ciudad Autónoma DE Buenos Aires
city: Viedma
country: Argentina
facility: Clinica Viedma S. A
state: RÍO Negro
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario
state: Santa FE
city: Rosario
country: Argentina
facility: Sanatorio de La Mujer
state: Santa FE
city: San Miguel de Tucuman
country: Argentina
facility: Centro Para la Atención Integral del Paciente Oncologico (CAIPO)
state: Tucumán
city: San Miguel de Tucumán
country: Argentina
facility: Exelsus - Oncología Clínica
state: Tucumán
city: Ciudad Autónoma Buenos Aires
country: Argentina
facility: Fundación Respirar
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro Medico Austral
city: Córdoba
country: Argentina
facility: Clínica Universitaria Reina Fabiola
city: La Rioja
country: Argentina
facility: Fundación CORI para la Investigación y Prevención del Cáncer
city: San Juan
country: Argentina
facility: COE (Centro Oncológico de Excelencia)
city: Santiago del Estero
country: Argentina
facility: Sanatorio Norte
city: North Ryde
country: Australia
facility: Macquarie University
state: New South Wales
city: Rosslea
country: Australia
facility: Icon Cancer Centre Townsville
state: Queensland
city: Salvador
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
state: Bahia
city: Fortaleza
country: Brazil
facility: Crio - Centro Regional Integrado de Oncologia
state: Ceará
city: Recife
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Pernambuco
state: Pernambuco
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer
state: RIO Grande DO Norte
city: Ijui
country: Brazil
facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisa Clínica - Área Administrativa
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos
state: SÃO Paulo
city: São Caetano do Sul
country: Brazil
facility: Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
state: SÃO Paulo
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
state: SÃO Paulo
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base de São José do Rio Preto
state: SÃO Paulo
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
state: SÃO Paulo
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base de São José do Rio Preto
state: SÃO Paulo
city: Pernambuco
country: Brazil
facility: Hospital Esperança Recife: Pronto Atendimento 24h
city: São Paulo
country: Brazil
facility: IBCC - Núcleo de Pesquisa e Ensino
city: Fredericton
country: Canada
facility: Dr. Everett Chalmers Regional Hospital
state: New Brunswick
city: Sydney
country: Canada
facility: Cape Breton Regional Hospital
state: Nova Scotia
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Chicoutimi
country: Canada
facility: CIUSSS- saguenay-Lac-Saint-Jean
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
state: Quebec
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Foshan
country: China
facility: The First People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Changchun
country: China
facility: Jilin Province Tumor Hospital
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjing
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute And Research Centre
state: Delhi
city: Surat
country: India
facility: Kiran Hospital - Multi Super Speciality Hospital and Research Center
state: Gujarat
city: Bangalore
country: India
facility: Spandana Oncology Centre (SOC)
state: Karnataka
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Kims Kingsway Hospital
state: Maharashtra
city: Nashik
country: India
facility: Apex Wellness Hospital
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Super Speciality Hospital
state: Maharashtra
city: Thane
country: India
facility: Bhakti Vedanta Hospital and Research Institute
state: Maharashtra
city: Udaipur
country: India
facility: GBH Memorial cancer Hospital and American International Institute of Medical sciences
state: Rajasthan
city: Kolkata
country: India
facility: Apollo Multispeciality Hospitals limited
state: WEST Bengal
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
state: Hadarom
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
state: Hamerkaz
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: Hatsafon
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Chiba-shi
country: Japan
facility: Chiba cancer center
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Otashi
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Koto
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokyo
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon-gwangyeoksi [incheon]
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Kyǒnggi-do
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Kyǒnggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyǒnggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Kyǒnggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Pusan-kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
state: Seoul-teukbyeolsi [seoul]
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
state: Taegu-kwangyǒkshi
city: Cuauhtémoc
country: Mexico
facility: Cryptex Investigación Clínica S.A. de C.V.
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Mexico Centre for Clinical Research S.A de C.V
state: Distrito Federal
city: Mexico City
country: Mexico
facility: COI Centro Oncologico Internacional S.A.P.I. de C.V.
state: Distrito Federal
city: Guadajalara
country: Mexico
facility: Boca Clinical Trials Mexico S.C.
state: Jalisco
city: Monterrey
country: Mexico
facility: Filios Alta Medicina S.A. de C.V.
state: Nuevo LEÓN
city: Chihuahua
country: Mexico
facility: Unidad de Investigación en Salud de Chihuahua, S.C.
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C.
city: Veracruz
country: Mexico
facility: Instituto Veracruzano en Investigación Clínica S.C.
city: Aarau
country: Switzerland
facility: Tumor Zentrum Aarau
state: Aargau
city: Olten
country: Switzerland
facility: Kantonsspital Olten
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
state: İ̇stanbul
city: Stanbul
country: Turkey
facility: Medipol Mega Universite Hastanesi
state: İ̇stanbul
city: Üsküdar / Stanbul
country: Turkey
facility: Acibadem Altunizade Hospital
state: İ̇stanbul
city: Izmir
country: Turkey
facility: Ege Universitesi Hastanesi
state: İ̇zmir
city: Ankara
country: Turkey
facility: Gulhane Egitim Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri
city: Ankara
country: Turkey
facility: Ultramar Medical Imaging Center
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Ankara
country: Turkey
facility: Ultramar Medical Imaging Center
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi
city: Ankara
country: Turkey
facility: Ultramar Medical Imaging Center
city: Diyarbakir
country: Turkey
facility: Dicle Üniversitesi
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim Arastirma Hastanesi
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tıp Fakultesi Hastaneleri
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi
city: Konya
country: Turkey
facility: Necmettin Erbakan Meram Medical Fac.
city: Samsun
country: Turkey
facility: Samsun Medical Park Hastanesi
city: Harlow
country: United Kingdom
facility: The Princess Alexandra Hospital NHS Trust
state: England
city: Truro
country: United Kingdom
facility: The Royal Cornwall Hospital
state: England
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust, Charing Cross Hospital
state: Hammersmith AND Fulham
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
state: London, CITY OF
city: Coventry
country: United Kingdom
facility: University Hospital Coventry & Warwickshire
state: Warwickshire
city: Guildford
country: United Kingdom
facility: The Royal Surrey County Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Swindon
country: United Kingdom
facility: Great Western Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: