Spots Global Cancer Trial Database for A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
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Trial Identification
Brief Title: A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
Official Title: A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer
Study ID: NCT03125902
Conditions
Study Description
Brief Summary: This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 \[PD-L1\] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stanford Cancer Center, Stanford, California, United States
Florida Cancer Specialists; Department of Oncology, Fort Myers, Florida, United States
Florida Cancer Specialist, North Region, Saint Petersburg, Florida, United States
Northwest Georgia Oncology Centers PC - Marietta, Marietta, Georgia, United States
HCA Midwest Health, Kansas City, Missouri, United States
The Valley Hospital, Paramus, New Jersey, United States
Magee-Woman's Hospital, Pittsburgh, Pennsylvania, United States
Tennessee Oncology; Sarah Cannon Research Institute, Nashville, Tennessee, United States
Centro Oncologico Riojano Integral (CORI), La Rioja, , Argentina
Santa Casa de Misericordia de Salvador, Salvador, BA, Brazil
Centro de Pesquisas Clinicas em Oncologia - CPCO, Cachoeiro de Itapemirim, ES, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiania, GO, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil
Hospital Perola Byington, Sao Paulo, SP, Brazil
Tom Baker Cancer Centre-Calgary, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Kingston General Hospital, Kingston, Ontario, Canada
Grand River Hospital, Kitchener, Ontario, Canada
London Regional Cancer Centre, London, Ontario, Canada
Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada
McGill University; Glen Site; Oncology, Montreal, Quebec, Canada
Hopital du Saint Sacrement, Quebec City, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont, Sherbrooke, Quebec, Canada
Cancer Hospital Chinese Academy of Medical Sciences., Beijing, , China
Beijing Union Hospital, Beijing, , China
West China Hospital, Sichuan University; Department of Breast, Chengdu, , China
Sun Yat-sen Memorial Hospital, Guangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Shandong Cancer Hospital, Jinan, , China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University), Nanjing City, , China
Jiangsu Cancer Hospital, Nanjing City, , China
Fudan University Shanghai Cancer Center, Shanghai City, , China
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital), Shanghai, , China
Liaoning cancer Hospital & Institute, Shenyang, , China
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province), Shijiazhuang, , China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, , China
The Second Affiliated Hospital of Xi'an Jiao Tong University, Xi'an City, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an, , China
Zhejiang Cancer Hospital, Zhejiang, , China
Henan Cancer Hospital, Zhengzhou, , China
Clinical Hospital Centre Zagreb, Zagreb, , Croatia
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology, Hradec Kralove, , Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc, , Czechia
Fakultni nemocnice Ostrava; Klinika onkologicka FNO a LF OU, Ostrava-Poruba, , Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika, Praha 2, , Czechia
Clinique Sainte Catherine; Hopital De Semaine, Avignon, , France
HOPITAL JEAN MINJOZ; Oncologie, Besancon, , France
Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France
Hopital Morvan, Brest, , France
CHD Les Oudairies, La Roche Sur Yon, , France
Centre Oscar Lambret; Senologie, Lille, , France
Centre Leon Berard; Departement Oncologie Medicale, Lyon, , France
Centre D'Oncologie de Gentilly; Oncology, Nancy, , France
Hopital Caremeau; Hematologie Oncologie, Nimes, , France
Hopital Tenon, Paris, , France
Institut Curie; Oncologie Medicale, Paris, , France
Hopital Saint Louis, Service D Oncologie Medicale, Paris, , France
Ch Pitie Salpetriere; Oncologie Medicale, Paris, , France
Centre Eugene Marquis; Service d'oncologie, Rennes, , France
Centre Paul Strauss; Oncologie Medicale, Strasbourg, , France
Institut Claudius Regaud; Departement Oncologie Medicale, Toulouse, , France
Institut Gustave Roussy; Sitep, VILLEJUIF Cedex, , France
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters, Berlin, , Germany
Onkologische Schwerpunktpraxis Bielefeld, Bielefeld, , Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum, Essen, , Germany
HOPA im Struensee-Haus, Dres. Erik Engel, Wiebke Hollburg, Hamburg, , Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg, Heidelberg, , Germany
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe, Koeln, , Germany
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde, Mainz, , Germany
OnkoNet Marburg GmbH, Marburg, , Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt, München, , Germany
Gemeinschaftspraxis für Hämatologie und Onkologie, Münster, , Germany
Klinikum Ernst von Bergmann; Frauenklinik, Potsdam, , Germany
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis, Troisdorf, , Germany
Universitätsklinik Tübingen; Frauenklinik, Tübingen, , Germany
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine, Athens, , Greece
ARETAIEION UNIVERSITY HOSPITAL; oncology unit, Athens, , Greece
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept., Kifisia, , Greece
Papageorgiou General Hospital; Medical Oncology, Thessaloniki, , Greece
Yashoda Hospital, Hyderabad, Andhra Pradesh, India
Dr. B L Kapur Memorial Hospital; BLK Cancer Centre, New Delhi, Delhi, India
Indraprastha Apollo Hospitals, New Delhi, Delhi, India
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology, New Delhi, Delhi, India
Max Super Speciality Hospital; Medical Oncology, North WEST Delhi, Delhi, India
Manipal Hospital; Department of Oncology, Bangalore, Karnataka, India
Tata Memorial Hospital; Dept of Medical Oncology, Mumbai, Maharashtra, India
Jehangir Hospital, Pune, Maharashtra, India
Apollo Speciality Hospital, Chennai, Tamil NADU, India
Apollo Gleneagles Hospitals, Kolkata, WEST Bengal, India
TATA Medical Centre; Medical Oncology, Kolkata, WEST Bengal, India
MAX Balaji Hospital, Delhi, , India
Hadassah Ein Karem Hospital; Oncology Dept, Jerusalem, , Israel
Rabin MC; Davidof Center - Oncology Institute, Petach Tikva, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Rambam Health Corporation; Oncology Institute, Rambam, , Israel
Kaplan Medical Center, Rehovot, , Israel
Tel Aviv Sourasky Medical Ctr; Oncology, Tel Aviv, , Israel
Assaf Harofeh; Oncology, Zerifin, , Israel
Fondazione Università G. D'Annunzio; Clinical Research Center (CRC); Centro Studi (CESI), Chieti, Abruzzo, Italy
Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia, Frattamaggiore, Campania, Italy
Azienda Ospedaliera Universitaria Federico II, Napoli, Campania, Italy
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Campania, Italy
Azienda Ospedaliero - Universitaria di Modena Policlinico, Modena, Emilia-Romagna, Italy
Universita Campus Bio-Medico di Roma (UCBM), Roma, Lazio, Italy
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B, Roma, Lazio, Italy
Azienda Policlinico Umberto I, Roma, Lazio, Italy
A.O. Universitaria S. Martino Di Genova, Genova, Liguria, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII), Bergamo, Lombardia, Italy
Asst Degli Spedali Civili Di Brescia, Brescia, Lombardia, Italy
Hospital San Raffaele, Milano, Lombardia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy
IEO Istituto Europeo di Oncologia;Divisione Oncologia Medica, Milano, Lombardia, Italy
IRCCS Istituto Clinico Humanitas; Oncologia, Rozzano (MI), Lombardia, Italy
Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo, Candiolo, Piemonte, Italy
Ospedale S. Vincenzo; Oncologia Medica, Taormina, Sicilia, Italy
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia, Firenze, Toscana, Italy
Ospedale Civile; Unita Operativa Di Oncologia Medica, Livorno, Toscana, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padova, Veneto, Italy
Gunma Prefectural Cancer Center, Gunma, , Japan
Hiroshima City Hiroshima Citizens Hospital, Hiroshima, , Japan
Sagara Hospital, Kagoshima, , Japan
Kanagawa Cancer Center, Kanagawa, , Japan
Tokai University Hospital, Kanagawa, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Naha-nishi Clinic, Okinawa, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Saitama Cancer Center, Saitama, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie, Marrakech, , Morocco
Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie, Rabat, , Morocco
Prof. Dr. I. Chiricuta Institute of Oncology, Cluj Napoca, , Romania
Centrul de Oncologie Sfantul Nectarie, Craiova, , Romania
Russian Oncology Research Center n.a. N.N. Blokhin, Moscow, Moskovskaja Oblast, Russian Federation
Petrov Research Inst. of Oncology, Sankt Petersburg, , Russian Federation
King Fahad Specialist Hospital; Oncology, Dammam, , Saudi Arabia
International Medical Center (IMC), Jeddah, , Saudi Arabia
King Fahad Medical City; Gastroentrology, Riyadh, , Saudi Arabia
Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A, Bratislava, , Slovakia
POKO Poprad; Department of Oncology, Poprad, , Slovakia
Wilgers Oncology Centre, Pretoria, , South Africa
Private Oncology Centre, Pretoria, , South Africa
Sandton Oncology Medical Group, Sandton, , South Africa
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia, A Coruña, LA Coruña, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología, Barcelona, , Spain
Hospital Universitario de Fuenlabrada; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia, Sevilla, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Sevilla, , Spain
Adana Baskent University Medical Faculty; Oncology, Adana, , Turkey
Ankara Bilkent City Hospital, Ankara, , Turkey
Uludag University Medical Faculty; Internal Medicine, Bursa, , Turkey
Dicle Uni Medical Faculty; Internal Medicine, Diyarbakir, , Turkey
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne, , Turkey
Izmir Ataturk Training and Research Hospital, Izmir, , Turkey
Kocaeli University Faculty of Medicine; Medical oncology, Izmit, , Turkey
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology, Kadiköy, , Turkey
Guys and St Thomas NHS Foundation Trust, Guys Hospital, London, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
Mount Vernon Cancer Centre, Northwood, , United Kingdom
K hospital, Hanoi, , Vietnam
Hochiminh city oncology hospital, Hochiminh city, , Vietnam
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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