Clinical trial NCT04975308: A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
Official title: EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Neoplasms
Neoplasm Metastasis
Keywords: SERD
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-07-23
Enrollment: 866
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 main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
* Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor

  -- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed
* Must be deemed appropriate for treatment with endocrine therapy
* If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
* Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
* Have adequate renal, hematologic, and hepatic organ function
* Must be able to swallow capsules/tablets

Exclusion Criteria:

* Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor
* Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.
* Have symptomatic or untreated brain metastasis.
* Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
* Known allergic reaction against any of the components of the study treatment

Primary outcomes:
measure: Progression Free Survival (PFS) in the Intent-to-Treat (IIT) Population
timeFrame: Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)
measure: PFS in the Estrogen Receptor 1 (ESR1)-mutation Detected Population
timeFrame: Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)
Secondary outcomes:
measure: Overall Survival (OS) in the IIT Population
timeFrame: Randomization until death from any cause (estimated as up to 5 years)
measure: OS in the ESR1-mutation Detected Population
timeFrame: Randomization until death from any cause (estimated as up to 5 years)
measure: Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)
timeFrame: Randomization until measured progressive disease (estimated as up to 1 year)
measure: Duration of Response (DoR)
timeFrame: Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years)
measure: Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks
timeFrame: Randomization until measured progressive disease (estimated as up to 1 year)
measure: Progression Free Survival (PFS)
timeFrame: Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years)
measure: Patient Reported Outcomes (PRO): Time to Worsening of "Worst Pain"
timeFrame: Screening through follow-up (estimated as up to 3 years)
measure: Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant
timeFrame: Cycle 2 to Cycle 4 (cycle = 28 days)
measure: PK: Steady State Plasma Concentrations of Imlunestrant and Abemaciclib
timeFrame: Cycle 2 to Cycle 4 (cycle = 28 days)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers
state: Arizona
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Greenbrae
country: United States
facility: Marin Cancer Care
state: California
city: Sacramento
country: United States
facility: University of California Davis (UC Davis) Comprehensive Cancer Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Loveland
country: United States
facility: Banner MD Anderson Cancer Center at McKee Medical Center
state: Colorado
city: Clermont
country: United States
facility: Clermont Oncology Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Honolulu
country: United States
facility: Kaiser Permanente Moanalua Medical Center
state: Hawaii
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem - Evanston Hospital
state: Illinois
city: Muncie
country: United States
facility: IU Health Ball Memorial Hospital, Inc.
state: Indiana
city: Louisville
country: United States
facility: The University of Louisville, James Graham Brown Cancer Center
state: Kentucky
city: Jackson
country: United States
facility: Jackson Oncology Associates, PLLC
state: Mississippi
city: Clifton
country: United States
facility: Care Access - Clifton
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering - Bergen
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Toledo
country: United States
facility: Mercy Health - St. Vincent Medical Center
state: Ohio
city: Sioux Falls
country: United States
facility: Avera Cancer Institute Sioux Falls
state: South Dakota
city: Nashville
country: United States
facility: Florida Cancer Specialists
state: Tennessee
city: Nashville
country: United States
facility: The Mark H Zangmeister Cancer Center
state: Tennessee
city: Allen
country: United States
facility: USO - Texas Oncology - Allen
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas Presbyterian Hospital
state: Texas
city: Houston
country: United States
facility: Willamette Valley Cancer Institute & Research Ctr.
state: Texas
city: Lewisville
country: United States
facility: Texas Oncology - Carrollton
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - Denison
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - Paris
state: Texas
city: The Woodlands
country: United States
facility: Blue Ridge Cancer Care
state: Texas
city: The Woodlands
country: United States
facility: Broome Oncology
state: Texas
city: The Woodlands
country: United States
facility: Minnesota Oncology/Hematology PA
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - Carrollton
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - McKinney
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - Medical City Dallas
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - Methodist Charlton Cancer Center
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - San Antonio Medical Center
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - The Woodlands
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - Willowbrook
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology Fort Worth
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: The Woodlands
country: United States
facility: USO-Rocky Mountain Cancer Center
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - Austin Central
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Burlington
country: United States
facility: The University of Vermont Medical Center Inc.
state: Vermont
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aires
city: Caba
country: Argentina
facility: Fundación Cenit Para La Investigación En Neurociencias
state: Ciudad Autónoma De Buenos Aires
city: Capital
country: Argentina
facility: Centro Medico Privado CEMAIC
state: Córdoba
city: Viedma
country: Argentina
facility: Clinica Viedma
state: Río Negro
city: Buenos Aires
country: Argentina
facility: Instituto Argentino de Diagnóstico y Tratamiento (IADT)
city: San Juan
country: Argentina
facility: Instituto San Marcos
city: Santiago del Estero
country: Argentina
facility: Sanatorio Norte
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Maroondah Hospital
state: Victoria
city: Graz
country: Austria
facility: Medizinische Universität Graz
state: Steiermark
city: Vienna
country: Austria
facility: Universitaetsklinikum Allgemeines Krankenhaus Wien
state: Wien
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
city: Bonheiden
country: Belgium
facility: Imelda General Hospital
state: Antwerpen
city: Brussels
country: Belgium
facility: UZ Brussel
state: Bruxelles-Capitale, Région De
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
state: Bruxelles-Capitale, Région De
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Kortrijk
country: Belgium
facility: AZ Groeninge Campus Kennedylaan
state: West-Vlaanderen
city: Namur
country: Belgium
facility: CHU UCL Namur/Site Sainte Elisabeth
city: Londrina
country: Brazil
facility: Hospital de Cancer de Londrina
state: Paraná
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: São Paulo
city: São Paulo
country: Brazil
facility: Icesp - Instituto Do Câncer Do Estado de São Paulo
city: São Paulo
country: Brazil
facility: Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA
city: São Paulo
country: Brazil
facility: Núcleo de Pesquisa Clínica da Rede São Camilo
city: Bengbu
country: China
facility: Afflilated Hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Fifth Medical Center of PLA General Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Centre
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Center Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan Peoples Hospital
state: Guangdong
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
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: Nanyang
country: China
facility: Nanyang Second General Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changde
country: China
facility: The First People's Hospital of Changde City
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The Third Hospital of Nanchang
state: Jiangxi
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Chengdu
country: China
facility: Sichuan Cancer hospital
state: Sichuan
city: Neijiang
country: China
facility: The Second People's Hospital of Neijiang
state: Sichuan
city: Tianjing
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Hwa Mei Hospital University of Chinese Academy of Sciences
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center
state: Zhejiang
city: Horovice
country: Czechia
facility: Nemocnice Horovice
state: Beroun
city: PRague
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
state: Praha 10
city: Prague
country: Czechia
facility: Fakultni Thomayerova nemocnice
state: Praha 4
city: Prague
country: Czechia
facility: Nemocnice Na Bulovce
state: Praha 8
city: Pribram
country: Czechia
facility: Oblastni nemocnice Pribram
state: Příbram
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe (ICANS)
state: Alsace
city: La Chaussée-Saint-Victor
country: France
facility: Polyclinique De Blois
state: Centre
city: Besançon
country: France
facility: CHU Besançon
state: Doubs
city: Saint-Cloud
country: France
facility: Hôpital René Huguenin
state: Hauts-de-Seine
city: Montpellier
country: France
facility: Centre de Cancérologie du Grand Montpellier
state: Languedoc-Roussillon
city: Le Mans
country: France
facility: Clinique Victor Hugo Le Mans
state: Pays-de-la-Loire
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque
state: Pyrénées-Atlantiques
city: Paris
country: France
facility: Institut Curie
city: Vandoeuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine Alexis Vautrin
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
state: Baden-Württemberg
city: Donauwörth
country: Germany
facility: Onkologiezentrum Donauwörth
state: Bayern
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
state: Bayern
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen
state: Bayern
city: Frankfurt
country: Germany
facility: Agaplesion Markus Krankenhaus
state: Hessen
city: Hannover
country: Germany
facility: Gynäkologisch-Onkologische Praxis am Pelikanplatz
state: Niedersachsen
city: Essen
country: Germany
facility: Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
state: Nordrhein-Westfalen
city: Mönchengladbach
country: Germany
facility: Evangelisches Krankenhaus Bethesda Mönchengladbach
state: Nordrhein-Westfalen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel
state: Schleswig-Holstein
city: Athens
country: Greece
facility: Agios Savvas Regional Cancer Hospital
state: Attikí
city: Athens
country: Greece
facility: Alexandra Hospital
state: Attikí
city: Nea Kifissia
country: Greece
facility: General Oncology Hospital of Kifissia "Agioi Anargiroi"
state: Attikí
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Irakleío
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki
state: Thessaloníki
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital of Thessaloniki
state: Thessaloníki
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center
state: Thessaloníki
city: Larissa
country: Greece
facility: University General Hospital of Larissa
state: Thessalía
city: Bangalore
country: India
facility: Medstar Speciality Hospital
state: Karnataka
city: Thiruvananthapuram
country: India
facility: Regional Cancer Centre - Thiruvananthapuram
state: Kerala
city: Mumbai
country: India
facility: HCG Cancer Centre
state: Maharashtra
city: Nagpur
country: India
facility: Government Medical College And Hospital - Nagpur
state: Maharashtra
city: Nagpur
country: India
facility: Rashtrasant Tukdoji Regional Cancer Hospital
state: Maharashtra
city: Nashik
country: India
facility: HCG Manavata Cancer Centre
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Centre
state: Maharashtra
city: Pune
country: India
facility: Lifepoint Multispeciality Hospital
state: Maharashtra
city: Hyderabad
country: India
facility: Yashoda Hospitals
state: Telangana
city: Naples
country: Italy
facility: University of Naples Federico II
state: Campania
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale
state: Campania
city: Aviano
country: Italy
facility: Cro-Irccs
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
state: Lazio
city: Genova
country: Italy
facility: Ospedale San Martino
state: Liguria
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
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: Kurume
country: Japan
facility: Kurume General Hospital
state: Fukuoka
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: Akashi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Kobe
country: Japan
facility: Shinko Hospital
state: Hyogo
city: Tsuchiura
country: Japan
facility: Tsuchiura Kyodo General Hospital
state: Ibaraki
city: Tsukuba
country: Japan
facility: Tsukuba University Hospital
state: Ibaraki
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa cancer center
state: Kanagawa
city: Tomitake
country: Japan
facility: Nagano Municipal Hospital
state: Nagano
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Shinagawa
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Hiroshima
country: Japan
facility: Hiroshima City Hospital
city: Kagoshima
country: Japan
facility: Sagara Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Shinto General Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Shizuoka
country: Japan
facility: Shizuoka General Hospital
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Cheonan-si
country: Korea, Republic of
facility: Soon Chun Hyang University Cheonan Hospital
state: Chungcheongnam-do [Chungnam]
city: Namdong-gu
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Incheon-gwangyeoksi [Incheon]
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Kyǒnggi-do
city: Daegu
country: Korea, Republic of
facility: Yeungnam Univeristy Medical Center
state: Kyǒngsangbuk-do
city: Busan
country: Korea, Republic of
facility: Dong-A 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
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
state: Taegu-Kwangyǒkshi
city: Torreón
country: Mexico
facility: Centro de Investigación Clínica de Alta Especialidad
state: Coahuila
city: Mexico City
country: Mexico
facility: Grupo Medico Camino Sc
state: Distrito Federal
city: Álvaro Obregón
country: Mexico
facility: COI Centro Oncologico Internacional S.A.P.I. de C.V.
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Private Practice - Dr. Joaquin Reinoso
state: Nuevo León
city: Monterrey
country: Mexico
facility: Filios Alta Medicina
state: Nuevo León
city: San Pedro Garza Garcia
country: Mexico
facility: Centro Medico Zambrano Hellion
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Unidad de Investigación en Salud
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization
city: Puebla
country: Mexico
facility: Unidad Médica Onco-hematológica
city: Leeuwarden
country: Netherlands
facility: Medische Centrum Leeuwarden
state: Fryslân
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis locatie Leyweg
state: Zuid-Holland
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Clinical Oncology Center
state: Kalužskaja Oblast'
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Cancer Clinic No.1
state: Volgogradskaya Oblast'
city: Saint Petersburg
country: Russian Federation
facility: N.N.Petrov Research Institute of Oncology
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeusa
state: Catalunya [Cataluña]
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalunya [Cataluña]
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
state: Extremadura
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova de Lleida
state: Lleida [Lérida]
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
state: Madrid, Comunidad De
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz De Tenerife
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia
state: Valenciana, Comunitat
city: Valencia
country: Spain
facility: Hospital Quirónsalud Valencia
state: València
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital - Liouying Branch
state: Tainan
city: Taichung
country: Taiwan
facility: Taichung Veterans General 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: Koo Foundation Sun Yat-Sen Cancer Center
city: Stanbul
country: Turkey
facility: Medipol University Medical Faculty
state: İstanbul
city: Üsküdar / Stanbul
country: Turkey
facility: Acibadem Altunizade Hospital
state: İstanbul
city: Adana
country: Turkey
facility: Baskent University Dr. Turgut Noyan Research and Training Center
city: Ankara
country: Turkey
facility: University of Health Sciences,Gulhane School of Medicine
city: Ankara
country: Turkey
facility: Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital
city: Ankara
country: Turkey
facility: Hacettepe Universitesi
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Hastanesi
city: Diyarbakir
country: Turkey
facility: Dicle Üniversitesi
city: Edirne
country: Turkey
facility: Trakya University
city: İstanbul
country: Turkey
facility: Acıbadem Maslak Hastanesi
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
city: Izmir
country: Turkey
facility: Ege Universitesi Hastanesi
city: Malatya
country: Turkey
facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi
city: Mersin
country: Turkey
facility: Mersin University
city: Kryvyi Rih
country: Ukraine
facility: Communal Enterprise 'Kryvyi Rih Oncology Dispensary' of the Dnipropetrovsk Regional Council
state: Dnipropetrovska Oblast
city: Kharkiv
country: Ukraine
facility: CNPE "Regional Center of Oncology"
state: Kharkivska Oblast
city: Odesa
country: Ukraine
facility: Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
state: Odeska Oblast
city: Lutsk
country: Ukraine
facility: Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council
state: Volynska Oblast
city: Uzhhorod
country: Ukraine
facility: Uzhgorod Central City Clinical Hospital
state: Zakarpatska Oblast
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: