Clinical trial NCT03498716: A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer
Official title: A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Triple Negative Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Breast International Group
name: Alliance Foundation Trials, LLC.
name: Jules Bordet Institute
name: Frontier Science & Technology Research Foundation, Inc.
First posted: 2018-04-17
Enrollment: 2199
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: This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)


Eligibility criteria: Inclusion Criteria:

* Non-metastatic operable Stage II-III breast cancer
* Histologically documented TNBC (Triple Negative Breast Cancer)
* Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen
* Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
* Adequate hematologic and end-organ function
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
* No more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization.
* Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical resection in paraffin blocks (preferred) or at least 25 unstained slides.

Exclusion Criteria

* Prior history of invasive breast cancer
* For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy.
* Previous therapy with anthracyclines or taxanes for any malignancy
* Cardiopulmonary dysfunction
* Prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Urinary outflow obstruction
* Active tuberculosis
* Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment or within 5 months following the last dose of Atezolizumab (for patients randomized to Atezolizumab)
* Prior allogeneic stem cell or solid organ transplant
* Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study

Primary outcomes:
measure: Invasive Disease-Free Survival (iDFS)
timeFrame: From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
Secondary outcomes:
measure: Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3)
timeFrame: From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
measure: Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation
timeFrame: From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
measure: Overall Survival (OS)
timeFrame: From randomization up to death from any cause (up to 5 years)
measure: Invasive Disease-Free Survival (iDFS) Including Second Primary Non-Breast Invasive Cancer
timeFrame: From randomization up to death from any cause (up to 5 years)
measure: Recurrence-Free Interval (RFI)
timeFrame: From randomization up to 5 years
measure: Distant Recurrence-Free Interval (DRFI)
timeFrame: From randomization up to 5 years
measure: Disease-Free Survival (DFS)
timeFrame: From randomization up to first disease recurrence or death from any cause (up to 5 years)
measure: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Patient-reported Function (Role Functioning [Q6, Q7])
timeFrame: Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles
measure: Change From Baseline in EORTC QLQ-C30 Patient-reported Function (Physical Functioning [Q1-Q5])
timeFrame: Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles
measure: Change From Baseline in EORTC QLQ-C30 Global Health Status (GHS) [Q29] and Health-Related Quality of Life (HRQoL) [Q30] Combined Score
timeFrame: Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately 351 days); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles
measure: Number of Participants With Adverse Events (AE)
timeFrame: Up to 5 years
measure: Serum Concentration of Atezolizumab
timeFrame: Postdose Day 1 of Cycle 1; Predose Day 1 of Cycles 2, 3, and 4; Predose Cycles 6, 10, and 14; Predose Day 2 of Cycle 16; Cycles 1-5= 28-day cycles; Cycles 6-16: 21-day cycles
measure: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Health Clinical Research Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Saint Helena
country: United States
facility: Martin-O?Neil Cancer Center
state: California
city: Jacksonville
country: United States
facility: Baptist - MD Anderson Cancer Center
state: Florida
city: Chicago
country: United States
facility: Advocate Illinois Masonic Outpatient Center for Advanced Care
state: Illinois
city: Des Moines
country: United States
facility: Des Moines Oncology Research Association
state: Iowa
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Comprehensive Cancer Center
state: Maryland
city: Edina
country: United States
facility: Fairview Southdale Medical Oncology Clinic
state: Minnesota
city: Kansas City
country: United States
facility: HCA Midwest Division
state: Missouri
city: Manchester
country: United States
facility: New Hampshire Hematology Oncology
state: New Hampshire
city: Lake Success
country: United States
facility: Monter Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital; Lipson Cancer and Blood Center
state: New York
city: Nashville
country: United States
facility: SCRI
state: Tennessee
city: Saint George
country: United States
facility: Intermountain Precision Genomics Cancer Research Clinic-Dixie
state: Utah
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
city: Berazategui
country: Argentina
facility: Centro de Oncologia e; Investigacion Buenos Aires - COIBA
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: INSTITUTO DE INVESTIGACIONES METABOLICAS (IDIM); Oncology
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Cordoba
country: Argentina
facility: Clinica Universitaria Reina Fabiola
city: Jujuy
country: Argentina
facility: Fundación Ars Medica
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (CORI)
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque
city: Viedma
country: Argentina
facility: Centro de Investigacion Clinica - Clinica Viedma S.A.; Oncology Department
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Lismore
country: Australia
facility: Lismore Base Hospital
state: New South Wales
city: Macquarie Park
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: Icon Cancer Care Wesley
state: Queensland
city: Chermside
country: Australia
facility: Icon Cancer Foundation; Icon Cancer Care Chermside
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Care South Brisbane
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Hospital; Cancer Services
state: Queensland
city: Southport
country: Australia
facility: Icon Cancer Foundation; Icon Cancer Care Southport
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital; Cancer Trials Unit
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital; Cancer Centre
state: South Australia
city: Kurralta Park
country: Australia
facility: Ashford Cancer Center Research
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital Olivia Newton John Cancer Centre
state: Victoria
city: Ringwood East
country: Australia
facility: Maroondah Hospital; Breast Clinic
state: Victoria
city: Innsbruck
country: Austria
facility: Medical University Innsbruck; Frauenklinik Innsbruck, Dept Gyn
city: Linz
country: Austria
facility: Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
city: Vienna
country: Austria
facility: AKH - Medizinische Universität Wien; Department of Oncology
city: Vöcklabruck
country: Austria
facility: Salzkammergut-Klinikum Voecklabruck
city: Wels
country: Austria
facility: Klinikum Kreuzschwestern Wels; Iv. Interne Abt.
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
city: Brasschaat
country: Belgium
facility: AZ KLINA
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liege
country: Belgium
facility: CHC MontLégia
city: Liège
country: Belgium
facility: Chr de La Citadelle
city: Mons
country: Belgium
facility: CHU Ambroise Paré
city: Namur
country: Belgium
facility: Clinique Sainte-Elisabeth; Oncologie
city: Sint Niklaas
country: Belgium
facility: Vitaz
city: Salvador, Bahia
country: Brazil
facility: Nucleo de Oncologia da Bahia - NOB
state: BA
city: Fortaleza
country: Brazil
facility: Crio - Centro Regional Integrado de Oncologia
state: CE
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - INCa; Oncologia
state: RJ
city: Volta Redonda
country: Brazil
facility: Hospital Jardim Amália
state: RJ
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
state: RS
city: Itajai
country: Brazil
facility: Clinica de Neoplasias Litoral
state: SC
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: SP
city: JAU
country: Brazil
facility: Hospital Amaral Carvalho
state: SP
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC - FMABC
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto Brasileiro de Controle Do Câncer ? São Camilo Oncologia
state: SP
city: São Paulo
country: Brazil
facility: Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira
state: SP
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Beijing Hospital; Internal Medicine-Oncology
city: Beijing
country: China
facility: Beijing Union Hospital
city: Changchun City
country: China
facility: The First Hospital of Jilin University
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Fuzhou City
country: China
facility: Fujian Medical University Union Hospital
city: Fuzhou
country: China
facility: The 900th Hospital of PLA joint service support force
city: Guangzhou
country: China
facility: Sun yat-sen University Cancer Center; Internal Medicine of Oncology
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center - Huangpu Campus
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University College
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Luoyang City
country: China
facility: Luoyang Central Hospital
city: Nanjing City
country: China
facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shenzhen City
country: China
facility: The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee
city: Shijiazhuang
country: China
facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
city: Wuhan City
country: China
facility: Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Xi'an City
country: China
facility: The First Affiliated Hospital of Xian Jiao Tong University
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Horovice
country: Czechia
facility: Nemocnice Horovice, NH Hospital a.s.; Oncology Department
city: Praha 2
country: Czechia
facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
city: Zlin
country: Czechia
facility: Krajska nemocnice T. Bati, a.s.
city: Herlev
country: Denmark
facility: Herlev Hospital; Afdeling for Kræftbehandling
city: Odense C
country: Denmark
facility: Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed
city: Vejle
country: Denmark
facility: Sygehus Lillebælt, Vejle
city: Ars-Laquenexy
country: France
facility: Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Beauvais
country: France
facility: CH de Beauvais
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Bordeaux
country: France
facility: Clinique Tivoli; Sce Radiotherapie
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Bourg-en- Bresse Cedex
country: France
facility: Centre Hospitalier Fleyriat
city: Brest
country: France
facility: CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie
city: Caen
country: France
facility: CRLCC-Francois Baclesse; Oncologie Médicale
city: Cholet
country: France
facility: CH de Cholet; oncologie
city: Compiegne
country: France
facility: Centre Hospitalier de Compiegne
city: Contamine Sur Arve
country: France
facility: Centre Hospitalier Alpes Leman
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental de Vendee
city: Limoges
country: France
facility: Clinique Chenieux; Oncology
city: Lorient
country: France
facility: Centre Hospitalier Bretagne Sud
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Montpellier
country: France
facility: Clinique Clémentville
city: Montpellier
country: France
facility: Institut régional du Cancer Montpellier
city: Nantes
country: France
facility: l'Hôpital privé du Confluent SAS
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Pringy
country: France
facility: CH Annecy Genevois site Annecy; Oncologie
city: Quimper
country: France
facility: Chi De Cornouaille; Oncologie Hospitalisation
city: Reims
country: France
facility: Institut Jean Godinot
city: Reims
country: France
facility: Institut du Cancer Coulancy Reims
city: Rouen
country: France
facility: Centre Henri Becquerel
city: St Priest en Jarez CEDEX
country: France
facility: Institut De Cancerologie Lucien Newrth
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Thonon Les Bains
country: France
facility: Hopitaux Du Leman - Site Georges Pianta
city: Toulouse
country: France
facility: Institut Claudius Régaud
city: Tours
country: France
facility: CHU Tours - Hôpital Bretonneau
city: Valence
country: France
facility: Hopital Prive Drome Ardeche; Hopital De Jour
city: Vandoeuvre-Les-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Villejuif
country: France
facility: Institut Gustave Roussy; Departement Oncologie Medicale
city: Berlin
country: Germany
facility: Studienzentrum Berlin City
city: Dortmund
country: Germany
facility: St. Johannes-Hospital
city: Dresden
country: Germany
facility: Onkozentrum Dres. Göhler
city: Dresden
country: Germany
facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
city: Erfurt
country: Germany
facility: Praxis für Hamatologie und Onkologie
city: Gütersloh
country: Germany
facility: Onkodok GmbH
city: Hamburg
country: Germany
facility: Albertinen-Krankenhaus Klinik f.Gynäkologie und Geburtshilfe
city: Hildesheim
country: Germany
facility: Ärztehaus am Bahnhofsplatz; Praxis Uleer/Pourfard
city: Karlsruhe
country: Germany
facility: ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik
city: Köln
country: Germany
facility: St. Elisabeth-Krankenhaus
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg; Studiensekretariat
city: Mainz
country: Germany
facility: St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
city: Mayen
country: Germany
facility: Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller
city: Memmingen
country: Germany
facility: Klinikum Memmingen; Abt.Gynäkologie
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin
city: Mönchengladbach
country: Germany
facility: Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
city: München
country: Germany
facility: Klinikum der Universität München; Frauenklinik - Onkologie II
city: Neumarkt i.d.OPf.
country: Germany
facility: Klinikum Neumarkt; Frauenklinik
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
city: Stendal
country: Germany
facility: Johanniter Frauenklinik Stendal Germany
city: Stralsund
country: Germany
facility: Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen; Frauenklinik
city: Weinheim
country: Germany
facility: GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe
city: Witten
country: Germany
facility: Marien-Hospital Witten, MVZ Witten
city: Worms
country: Germany
facility: Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital Department of Clinical Oncology
city: Budapest
country: Hungary
facility: National Institute of Oncology, A Dept of Internal Medicine
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
city: Dublin
country: Ireland
facility: Mater Misecordiae University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital; Cancer Clinical Trials Unit
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Med Org Kiryat; Oncology Institute
city: Kfar Sava
country: Israel
facility: Meir Medical center, Pediatrics
city: Petach Tikva
country: Israel
facility: Rabin MC; Davidof Center - Oncology Institute
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
state: Abruzzo
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi; UO Farmacia Clinica
state: Emilia-Romagna
city: Carpi
country: Italy
facility: U.O Medicina Oncologica Ospedale di Carpi
state: Emilia-Romagna
city: Faenza
country: Italy
facility: Ospedale Degli Infermi - Faenza; Oncologia Medica
state: Emilia-Romagna
city: Modena
country: Italy
facility: Azienda Ospedaliero - Universitaria di Modena Policlinico
state: Emilia-Romagna
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
state: Emilia-Romagna
city: Rimini
country: Italy
facility: Ospedale degli Infermi
state: Emilia-Romagna
city: Udine
country: Italy
facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico Di Roma
state: Lazio
city: Genova
country: Italy
facility: Azienda Ospedaliero Universitaria San Martino
state: Liguria
city: Lecco
country: Italy
facility: ASST DI LECCO; Oncologia Medica
state: Lombardia
city: Legnago (VR)
country: Italy
facility: Ospedale Mater Salutis
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri
state: Lombardia
city: Pavia
country: Italy
facility: Policlinico San Mattea
state: Lombardia
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: Alessandria
country: Italy
facility: Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
state: Piemonte
city: Ponderano (BI)
country: Italy
facility: Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica
state: Piemonte
city: Bagno a Ripoli
country: Italy
facility: Ospedale Santa Maria Annunziata; Oncologia
state: Toscana
city: Poggibonsi
country: Italy
facility: Azienda Usl 7; Dept. Oncologico
state: Toscana
city: Prato
country: Italy
facility: Nuovo Ospedale Di Prato
state: Toscana
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
state: Umbria
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Ehime
country: Japan
facility: Shikoku Cancer Center
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
city: Hokkaido
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
city: Hyogo
country: Japan
facility: Hyogo Medical University Hospital
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital
city: Kagoshima
country: Japan
facility: Sagara Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Miyagi
country: Japan
facility: Fukushima Medical University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Okinawa
country: Japan
facility: Naha-nishi Clinic
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Saitama
country: Japan
facility: Saitama Medical University International Medical Center
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: St. Luke's Internat. Hospital, Breast Surgical Oncology
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Cheongju si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Dongnam-gu, Cheonan-si
country: Korea, Republic of
facility: Soon Chun Hyang University Cheonan Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang 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: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Suwon City
country: Korea, Republic of
facility: Ajou University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hosiptal
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
city: Cdmx
country: Mexico
facility: Health Pharma Professional Research
state: Mexico CITY (federal District)
city: D.f.
country: Mexico
facility: Iem-Fucam
state: Mexico CITY (federal District)
city: Distrito Federal
country: Mexico
facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
state: Mexico CITY (federal District)
city: Monterrey
country: Mexico
facility: Centro Médico Zambrano Hellion
state: Nuevo LEON
city: Oaxaca de Juárez
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
state: Oaxaca
city: San Luis Potosí
country: Mexico
facility: Oncologico Potosino
state: SAN LUIS Potosi
city: Mérida
country: Mexico
facility: Merida | Investigacion Clinica
state: Yucatan
city: Mexico City
country: Mexico
facility: CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO
city: Mexico City
country: Mexico
facility: Centro Medico Dalinde
city: Arequipa
country: Peru
facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Lima
country: Peru
facility: Oncosalud Sac; Oncología
city: ?ód?
country: Poland
facility: Instytut MSF Sp. z o.o.
city: Poznan
country: Poland
facility: MedPolonia
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologi
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy; Klinika Onkologii
city: Bucharest
country: Romania
facility: "Filantropia" Clinical Hospital; Gynecological Oncology
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantul Nectarie
city: Moscow
country: Russian Federation
facility: Medsi Clinic
state: Adygeja
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Oncology Dispensary
state: Arhangelsk
city: UFA
country: Russian Federation
facility: Bashkirian Republican Clinical Oncology Dispensary
state: Baskortostan
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Oncology Hospital
state: Jaroslavl
city: Sochi
country: Russian Federation
facility: Oncologica Dispensary #2
state: Krasnodar
city: Chelyabinsk
country: Russian Federation
facility: Evimed
state: Kurgan
city: Saransk
country: Russian Federation
facility: Mordovia State University
state: Mordovija
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific Center
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: P.A. Herzen Oncological Inst. ; Oncology
state: Moskovskaja Oblast
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Clinical Oncology Center
state: Niznij Novgorod
city: Rostov-na-donu
country: Russian Federation
facility: National Medical Research Center for Oncology
state: Rostov
city: Saint-Petersburg
country: Russian Federation
facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
state: Sankt Petersburg
city: Saint-Petersburg
country: Russian Federation
facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
state: Sankt Petersburg
city: Sankt-peterburg
country: Russian Federation
facility: LLC Strategic Medical Systems
state: Sankt Petersburg
city: Sankt-peterburg
country: Russian Federation
facility: EosMed LLC
state: Sankt Petersburg
city: Sankt-peterburg
country: Russian Federation
facility: LCC Center of Palliative Medicine - Devita
state: Sankt Petersburg
city: St. Petersburg
country: Russian Federation
facility: Private Healthcare Institution Clinical Hospital RZhD Medicine
state: Sankt Petersburg
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsky Oncologic Dispensary
state: Stavropol
city: Irkutsk
country: Russian Federation
facility: Regional Oncology Hospital
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Novgorod Veliky
country: Russian Federation
facility: Regional Oncology Dispensary; Dept of Chemotherapy
city: Omsk
country: Russian Federation
facility: BIH at Omsk Region "Clinical Oncology Dispensary", Outpatient clinic
city: Samara
country: Russian Federation
facility: Multidisciplinary clinic Reaviz
city: Samara
country: Russian Federation
facility: Samara Regional Oncology Dispensary
city: Saratov
country: Russian Federation
facility: Regional Clinical Hospital
city: Volgograd
country: Russian Federation
facility: SHI Volgograd Regional Clinical Oncological Dispensary#1
city: Singapore
country: Singapore
facility: National University Hospital; Medical Oncology
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
state: Barcelona
city: Sant Cugat Del Valles
country: Spain
facility: Hospital General De Catalunya; Servicio de Oncologia
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Hospitalari de Terrassa
state: Barcelona
city: Jerez De La Frontera
country: Spain
facility: Hospital de Jerez
state: Cadiz
city: Castellon DE LA Plana/castello DE LA Plana
country: Spain
facility: Hospital Provincial Castellón
state: Castellon
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Islas Baleares
city: A Coruna
country: Spain
facility: Centro Oncologico de Galicia COG; Medical Oncology
state: LA Coruña
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
state: LA Coruña
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
state: Madrid
city: San Sebastian de Los Reyes
country: Spain
facility: Hospital Infanta Sofia; Servico de Oncologia
state: Madrid
city: Vigo
country: Spain
facility: Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología
state: Pontevedra
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus; Planta baja, color lila
state: Tarragona
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias;servicio de Oncologia
state: Tenerife
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Caceres
country: Spain
facility: Hospital San Pedro De Alcantara; Servicio de Oncologia
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Madrid
country: Spain
facility: Centro Integral Oncológico Clara Campal Ensayos Clínicos START
city: Madrid
country: Spain
facility: Hosp Univ Fundacion Alcorcon
city: Madrid
country: Spain
facility: Hospital Universitario de Fuenlabrada; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Quirón Sagrado Corazón
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologia; Oncologia Medica
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia; Servicio de oncologia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
city: Aarau
country: Switzerland
facility: Hirslanden Medical Center - Tumorzentrum
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois - Lausanne
city: Zürich
country: Switzerland
facility: Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
city: Changhua
country: Taiwan
facility: Chunghua Christian hospital
city: Kaoshiung City
country: Taiwan
facility: Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital
city: Kaoshiung
country: Taiwan
facility: E-Da Cancer Hospital; Hematology- Oncology Department
city: Liuying Township
country: Taiwan
facility: Chi Mei Medical Center Liou Ying Campus
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: Mackay Memorial Hospital - Taipei Branch
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundation Linkou Branch
city: Bangkok
country: Thailand
facility: Rajavithi Hospital; Division of Medical Oncology
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital; Medicine/Oncology
city: Bangkok
country: Thailand
facility: Siriraj Hospital; Clinical Research Center, Pharmacy Department
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen University
city: Muang Lampang
country: Thailand
facility: Lampang Cancer Hospital
city: Patumwan
country: Thailand
facility: King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University
city: Adana
country: Turkey
facility: Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
city: Bursa
country: Turkey
facility: Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi
city: Izmir
country: Turkey
facility: Izmir Ekonomi Universitesi Medical Park Hastanesi
city: Mersin
country: Turkey
facility: Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi
city: Samsun
country: Turkey
facility: Medikal Park Samsun
city: Zaporizhzhia
country: Ukraine
facility: Yulis Medical and Diagnostic Center
state: Katerynoslav Governorate
city: Dnipro
country: Ukraine
facility: MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department
state: KIEV Governorate
city: Odesa
country: Ukraine
facility: Municipal Institution Odesa Regional Oncology Dispensary
state: KIEV Governorate
city: Vinnytsya
country: Ukraine
facility: Vinnytsya Regional Clinical Oncology Dispensary
state: Podolia Governorate
city: Chernigiv
country: Ukraine
facility: Regional Oncology Center; Department of Mammology
city: Chernivtsi
country: Ukraine
facility: Chernivtsi Regional Clinical Oncology Dispensary
city: Dnipropetrovsk
country: Ukraine
facility: City Clinical Hospital #4
city: Kirovograd
country: Ukraine
facility: Municipal Institution Kirovograd Regional Oncology Dispensary
city: Kryvyi Rih
country: Ukraine
facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
city: Lutsk
country: Ukraine
facility: Volyn Regional Oncology Dispensary
city: Lviv
country: Ukraine
facility: Lviv State Oncological Regional Treatment and Diagnostic Center
city: Odesa
country: Ukraine
facility: Municipal Institution Odesa Regional Clinical Hospital
city: Sumy
country: Ukraine
facility: Sumy Reg. Clin. Oncological Dispensary; Thoracall Department
city: Uzhgorod
country: Ukraine
facility: CCCH City Oncological Center SHEI Uzhgorod NU
city: Uzhgorod
country: Ukraine
facility: Transkarpathian Regional Oncology Clinic; Chemotherapy
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University
city: Edinburgh
country: United Kingdom
facility: NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
city: Huddersfield
country: United Kingdom
facility: Calderdale and Huddersfield NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hosp NHS Trust;St James's Institute of Onc
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust - City Hospital
city: Stoke-On-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.