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Brief Title: A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer
Official Title: A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer
Study ID: NCT03371017
Brief Summary: This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Florida Cancer Specialists - Fort Myers (Broadway), Fort Myers, Florida, United States
Florida Cancer Specialists & Research Institute, Saint Petersburg, Florida, United States
The Valley Hospital, Paramus, New Jersey, United States
Magee-Woman's Hospital; UPMC Pinnacle Cancer Center, Harrisburg, Pennsylvania, United States
Magee-Woman's Hospital, Pittsburgh, Pennsylvania, United States
SCRI Oncology Partners, Nashville, Tennessee, United States
Inova Schar Cancer Institute, Falls Church, Virginia, United States
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires, , Argentina
Instituto de Oncología de Rosario, Rosario, , Argentina
Hospital Provincial del Centenario, Rosario, , Argentina
University Clinical Center of the Republic of Srpska, Banja Luka, , Bosnia and Herzegovina
Clinical center University of Sarajevo, Sarajevo, , Bosnia and Herzegovina
Oncocentro Serviços Medicos E Hospitalares Ltda, Fortaleza, CE, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiania, GO, Brazil
Hospital do Cancer de Pernambuco - HCP, Recife, PE, Brazil
Hospital Sao Vicente de Paulo, Passo Fundo, RS, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, Brazil
Centro de Oncologia de Santa Catarina LTDA, Chapeco, SC, Brazil
Instituto de Pesquisa Grupo NotreDame Intermedica, Sao Paulo, SP, Brazil
Hospital Perola Byington, Sao Paulo, SP, Brazil
Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA, Sao Paulo, SP, Brazil
Patagonia Research, Puerto Montt, , Chile
Bradford Hill Centro de Investigaciones Clinicas, Recoleta, , Chile
Fundacion Arturo Lopez Perez, Santiago, , Chile
Clinica Vespucio, Santiago, , Chile
James Lind Centro de Investigación Del Cáncer, Temuco, , Chile
ONCOCENTRO APYS; Oncología, Vina Del Mar, , Chile
Cancer Hospital , Chinese Academy of Medical, Beijing City, , China
Peking University People's Hospital, Beijing, , China
Beijing Cancer Hospital, Beijing, , China
the First Affiliated Hospital of Bengbu Medical College, Bengbu City, , China
Jilin Cancer Hospital, Changchun, , China
Hunan Cancer Hospital, Changsha CITY, , China
The First Affiliated Hospital, Chongqing Medical University, Chongqing, , China
Fujian Medical University Union Hospital, Fuzhou City, , China
Sun Yat-sen Memorial Hospital, Guangzhou, , China
Sir Run Run Shaw Hospital Zhejiang University, Hangzhou City, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Shandong Cancer Hospital, Jinan, , China
The First Affiliated Hospital Of Jinzhou Medical University, Jinzhou City, , China
Jiangsu Province Hospital, Nanjing, , China
The Affiliated Hospital of Medical College Qingdao University, Qingdao, , China
Fudan University Shanghai Cancer Center; Medical Oncology, Shanghai City, , China
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province), Shijiazhuang, , China
Shanxi Province Cancer Hospital, Taiyuan City, , China
Tianjin Cancer Hospital, Tianjin, , China
The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital), Xi'an, , China
Zhejiang Cancer Hospital, Zhejiang, , China
Hospital Hermanos Ameijeiras, La Habana, , Cuba
Instituto Nacional de Oncología y Radiología (INOR), La Habana, , Cuba
Helsinki University Central Hospital; Dept of Oncology, Helsinki, , Finland
Tampere University Hospital; Dept of Oncology, Tampere, , Finland
Centre Georges-François Lecler; Ctr de Lutte Contre le Canc, Dijon, , France
Centre Leon Berard; Oncologie Genetique, Lyon, , France
Institut Paoli-Calmettes; Oncologie Medicale 1, Marseille Cedex 09, , France
Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque, Montpellier, , France
Centre Eugene Marquis; Service d'oncologie, Rennes, , France
INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale., St Cloud, , France
Centre Alexis Vautrin; Oncologie Medicale, Vandoeuvre-les-nancy, , France
IGR, Villejuif, , France
Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe, Dresden, , Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum, Essen, , Germany
Varisano Klinikum Frankfurt Höchst GmbH, Frankfurt, , Germany
Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie, Halle, , Germany
Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe, Hannover, , Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg, Heidelberg, , Germany
Medizinisches Zentrum für Hämatologie und Onkologie, München, , Germany
Szent Margit Hospital, Budapest, , Hungary
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly, Budapest, , Hungary
Budapesti Uzsoki Utcai Kórház, Budapest, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez, Miskolc, , Hungary
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet, Pécs, , Hungary
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale, Napoli, Campania, Italy
Azienda Ospedaliero Universitaria San Martino, Genova, Liguria, Italy
Ospedale San Raffaele S.r.l., Milano, Lombardia, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica, Milano, Lombardia, Italy
Ospedale San Gerardo, Monza, Lombardia, Italy
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico, Candiolo, Piemonte, Italy
Ospedale Antonio Perrino; Oncologia Medica, Brindisi, Puglia, Italy
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia, Firenze, Toscana, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda, Padova, Veneto, Italy
Kazakh Scientific Research Institution Of Oncology and Radiology, Almaty, , Kazakhstan
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Centro Medico Dalinde, Cdmx, Mexico CITY (federal District), Mexico
CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO, Mexico City, , Mexico
Instituto Nacional de Cancerologia; Oncology, Mexico City, , Mexico
Clinical Center of Montenegro; Clinic for Oncology and Radiotherapy, Podgorica, , Montenegro
Centre Hospitalier Universitaire Hassan II, FES, , Morocco
Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie, Marrakech, , Morocco
Clinique specialise Menara; Oncology Medical, Marrakech, , Morocco
Institut National D'oncologie Sidi Med Benabdellah, Rabat, , Morocco
The Panama Clinic, Panama, , Panama
Instituto Nacional de Enfermedades Neoplasicas, Lima, , Peru
?wi?tokrzyskie Centrum Onkologii; Dzia? Chemioterapii, Kielce, , Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr, Warszawa, , Poland
Hospital de Santa Maria; Servico de Oncologia Medica, Lisboa, , Portugal
Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia, Porto, , Portugal
Moscow City Oncology Hospital #62, Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation
Moscow Clinical Scientific Center, Moscow, Moskovskaja Oblast, Russian Federation
FSBI "National Medical Research Center of Oncology N.N. Blokhin?, Moscow, Moskovskaja Oblast, Russian Federation
City Clinical Oncology Dispensary, SPb SBIH CCOD, Saint-Petersburg, Sankt Petersburg, Russian Federation
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov", Saint-Petersburg, Sankt Petersburg, Russian Federation
Private Healthcare Institution Clinical Hospital RZhD Medicine, St. Petersburg, Sankt Petersburg, Russian Federation
Institute of Oncology and Radiology of Serbia, Belgrade, , Serbia
University Hospital Medical Center Bezanijska kosa, Belgrade, , Serbia
Clinical Centre Nis, Clinic for Oncology, Nis, , Serbia
Oncology Institute of Vojvodina, Sremska Kamenica, , Serbia
National Cancer Centre; Medical Oncology, Singapore, , Singapore
Wits Clinical Research; Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, , South Africa
Medical Oncology Centre of Rosebank; Oncology, Johannesburg, , South Africa
Private Oncology Centre, Pretoria, , South Africa
Hospital de Cruces; Servicio de Oncologia, Bilbao, Vizcaya, Spain
Hospital Universitari Vall d'Hebron; Oncology, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Malaga, , Spain
Hospital Clínico Universitario de Valencia; Servicio de Oncología, Valencia, , Spain
Hacettepe University Medical Faculty; Department of Internal Medicine, Ankara, , Turkey
Ankara Oncology Hospital; Medical Oncology Department, Ankara, , Turkey
Ege University Medical Faculty; Medical Oncology Department, Bornova, ?zm?r, , Turkey
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne, , Turkey
Medipol University Medical Faculty; Oncology Department, Istanbul, , Turkey
Marmara University Pendik Training and Research Hospital; Medikal Onkoloji, Istanbul, , Turkey
Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases, Konya, , Turkey
Velindre Cancer Centre; Oncology Dept, Cardiff, , United Kingdom
University Hospital Coventry, Coventry, , United Kingdom
Western General Hospital; Edinburgh Cancer Center, Edinburgh, , United Kingdom
Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust, Lancaster, , United Kingdom
Barts, London, , United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital, London, , United Kingdom
Christie Hospital NHS Trust, Manchester, , United Kingdom
Mount Vernon Cancer Centre, Northwood, , United Kingdom
Royal Stoke University Hospital, Stoke-on-Trent, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR