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
Who is this study for? Adult patients with stage II-III triple negative breast cancer
What treatments are being studied? Atezolizumab
Status: Terminated
Location: See all (361) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
John Muir Health Clinical Research Center
Concord
Cedars-Sinai Medical Center
Los Angeles
Martin-O?Neil Cancer Center
St. Helena
Florida
Baptist - MD Anderson Cancer Center
Jacksonville
Iowa
Des Moines Oncology Research Association
Des Moines
Illinois
Advocate Illinois Masonic Outpatient Center for Advanced Care
Chicago
Kansas
Cancer Center of Kansas
Wichita
Maryland
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore
Minnesota
Fairview Southdale Medical Oncology Clinic
Edina
Missouri
HCA Midwest Division
Kansas City
New Hampshire
New Hampshire Hematology Oncology
Manchester
New York
Monter Cancer Center
Lake Success
Memorial Sloan Kettering Cancer Center
New York
Rochester General Hospital; Lipson Cancer and Blood Center
Rochester
Tennessee
SCRI
Nashville
Utah
Intermountain Precision Genomics Cancer Research Clinic-Dixie
St. George
West Virginia
St. Mary's Medical Center
Huntington
Other Locations
Argentina
Centro de Oncologia e; Investigacion Buenos Aires - COIBA
Berazategui
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires
INSTITUTO DE INVESTIGACIONES METABOLICAS (IDIM); Oncology
Ciudad Autonoma Buenos Aires
Clinica Universitaria Reina Fabiola
Córdoba
Centro Oncologico Riojano Integral (CORI)
La Rioja
Instituto de Oncología de Rosario
Rosario
Centro Medico San Roque
San Miguel De Tucumán
Fundación Ars Medica
San Salvador De Jujuy
Centro de Investigacion Clinica - Clinica Viedma S.A.; Oncology Department
Viedma
Australia
Royal Adelaide Hospital; Cancer Centre
Adelaide
Icon Cancer Care Wesley
Auchenflower
Icon Cancer Foundation; Icon Cancer Care Chermside
Chermside
Monash Medical Centre
Clayton
St Vincent's Hospital Sydney
Darlinghurst
Austin Hospital Olivia Newton John Cancer Centre
Heidelberg
Ashford Cancer Center Research
Kurralta Park
Lismore Base Hospital
Lismore
Macquarie University Hospital
Macquarie Park
Maroondah Hospital; Breast Clinic
Ringwood East
Icon Cancer Care South Brisbane
South Brisbane
Mater Hospital; Cancer Services
South Brisbane
Icon Cancer Foundation; Icon Cancer Care Southport
Southport
Sydney Adventist Hospital
Wahroonga
Princess Alexandra Hospital; Cancer Trials Unit
Woolloongabba
Austria
Medical University Innsbruck; Frauenklinik Innsbruck, Dept Gyn
Innsbruck
Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie
Linz
Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
Salzburg
AKH - Medizinische Universität Wien; Department of Oncology
Vienna
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
Vienna
Salzkammergut-Klinikum Voecklabruck
Vöcklabruck
Klinikum Kreuzschwestern Wels; Iv. Interne Abt.
Wels
Belgium
AZ KLINA
Brasschaat
Institut Jules Bordet
Brussels
UZ Leuven Gasthuisberg
Leuven
CHC MontLégia
Liège
Chr de La Citadelle
Liège
CHU Ambroise Paré
Mons
Clinique Sainte-Elisabeth; Oncologie
Namur
Vitaz
Sint-niklaas
Brazil
Hospital de Cancer de Barretos
Barretos
Crio - Centro Regional Integrado de Oncologia
Fortaleza
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí
Clinica de Neoplasias Litoral
Itajaí
Hospital Amaral Carvalho
Jaú
Hospital das Clinicas - UFRGS
Porto Alegre
Hospital Mae de Deus
Porto Alegre
Hospital Moinhos de Vento
Porto Alegre
Instituto Nacional de Cancer - INCa; Oncologia
Rio De Janeiro
Nucleo de Oncologia da Bahia - NOB
Salvador, Bahia
Faculdade de Medicina do ABC - FMABC
Santo André
Instituto Brasileiro de Controle Do Câncer ? São Camilo Oncologia
São Paulo
Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira
São Paulo
Hospital Jardim Amália
Volta Redonda
China
Beijing Hospital; Internal Medicine-Oncology
Beijing
Beijing Union Hospital
Beijing
Peking University People's Hospital
Beijing
Jilin Cancer Hospital
Changchun
The First Hospital of Jilin University
Changchun
West China Hospital, Sichuan University
Chengdu
Chongqing Cancer Hospital
Chongqing
Fujian Medical University Union Hospital
Fuzhou
The 900th Hospital of PLA joint service support force
Fuzhou
Guangdong General Hospital
Guangzhou
Sun Yat-Sen University Cancer Center - Huangpu Campus
Guangzhou
Sun yat-sen University Cancer Center; Internal Medicine of Oncology
Guangzhou
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou
The Second Affiliated Hospital of Zhejiang University College
Hangzhou
Harbin Medical University Cancer Hospital
Harbin
Shandong Cancer Hospital
Jinan
Luoyang Central Hospital
Luoyang
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
Shanghai
Zhongshan Hospital Fudan University
Shanghai
The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee
Shenzhen
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
Shijiazhuang
Hubei Cancer Hospital
Wuhan
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an
Zhejiang Cancer Hospital
Zhejiang
Henan Cancer Hospital
Zhengzhou
Denmark
Herlev Hospital; Afdeling for Kræftbehandling
Herlev
Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed
Odense C
Sygehus Lillebælt, Vejle
Vejle
France
Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy
Ars-laquenexy
Institut Sainte Catherine
Avignon
CH de Beauvais
Beauvais
CHU Jean Minjoz
Besançon
Clinique Tivoli; Sce Radiotherapie
Bordeaux
Polyclinique Bordeaux Nord Aquitaine
Bordeaux
Centre Hospitalier Fleyriat
Bourg-en-bresse
CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie
Brest
CRLCC-Francois Baclesse; Oncologie Médicale
Caen
CH de Cholet; oncologie
Cholet
Centre Hospitalier de Compiegne
Compiègne
Centre Hospitalier Alpes Leman
Contamine-sur-arve
Centre Georges Francois Leclerc
Dijon
Centre Hospitalier Departemental de Vendee
La Roche-sur-yon
Clinique Chenieux; Oncology
Limoges
Centre Hospitalier Bretagne Sud
Lorient
Hopital Prive Jean Mermoz
Lyon
Hôpital Saint Joseph
Marseille
Clinique Clémentville
Montpellier
Institut régional du Cancer Montpellier
Montpellier
l'Hôpital privé du Confluent SAS
Nantes
Centre Antoine Lacassagne
Nice
CH Annecy Genevois site Annecy; Oncologie
Pringy
Chi De Cornouaille; Oncologie Hospitalisation
Quimper
Institut du Cancer Coulancy Reims
Reims
Institut Jean Godinot
Reims
Centre Henri Becquerel
Rouen
Institut De Cancerologie Lucien Newrth
Saint-priest-en-jarez
Centre Paul Strauss
Strasbourg
Hopitaux Du Leman - Site Georges Pianta
Thonon-les-bains
Institut Claudius Régaud
Toulouse
CHU Tours - Hôpital Bretonneau
Tours
Hopital Prive Drome Ardeche; Hopital De Jour
Valence
Institut de Cancérologie de Lorraine
Vandœuvre-lès-nancy
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif
Germany
Studienzentrum Berlin City
Berlin
St. Elisabeth-Krankenhaus
Cologne
St. Johannes-Hospital
Dortmund
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
Dresden
Onkozentrum Dres. Göhler
Dresden
Praxis für Hamatologie und Onkologie
Erfurt
Onkodok GmbH
Gütersloh
Albertinen-Krankenhaus Klinik f.Gynäkologie und Geburtshilfe
Hamburg
Ärztehaus am Bahnhofsplatz; Praxis Uleer/Pourfard
Hildesheim
ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik
Karlsruhe
Klinikum Ludwigsburg; Studiensekretariat
Ludwigsburg
St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz
Mainz
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz
Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller
Mayen
Klinikum Memmingen; Abt.Gynäkologie
Memmingen
Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin
Minden
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
Mönchengladbach
Klinikum der Universität München; Frauenklinik - Onkologie II
München
Klinikum Neumarkt; Frauenklinik
Neumarkt In Der Oberpfalz
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
Offenbach
Johanniter Frauenklinik Stendal Germany
Stendal
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
Stralsund
Universitätsklinik Tübingen; Frauenklinik
Tübingen
GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe
Weinheim
Marien-Hospital Witten, MVZ Witten
Witten
Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe
Worms
Hong Kong Special Administrative Region
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
Hong Kong
Queen Mary Hospital
Hong Kong
Queen Elizabeth Hospital Department of Clinical Oncology
Kowloon
Hungary
National Institute of Oncology, A Dept of Internal Medicine
Budapest
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
Miskolc
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
Pécs
Ireland
Beaumont Hospital; Cancer Clinical Trials Unit
Dublin
Mater Misecordiae University Hospital
Dublin
Israel
Hadassah Med Org Kiryat; Oncology Institute
Jerusalem
Shaare Zedek Medical Center
Jerusalem
Meir Medical center, Pediatrics
Kfar Saba
Rabin MC; Davidof Center - Oncology Institute
Petah Tikva
The Chaim Sheba Medical Center
Ramat Gan
Italy
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
Alessandria
Ospedale Santa Maria Annunziata; Oncologia
Bagno A Ripoli
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi; UO Farmacia Clinica
Bologna
U.O Medicina Oncologica Ospedale di Carpi
Carpi
Ospedale Degli Infermi - Faenza; Oncologia Medica
Faenza
Azienda Ospedaliero Universitaria San Martino
Genoa
ASST DI LECCO; Oncologia Medica
Lecco
Ospedale Mater Salutis
Legnago (vr)
Istituto Europeo Di Oncologia
Milan
Azienda Ospedaliero - Universitaria di Modena Policlinico
Modena
Azienda Ospedaliero Universitaria di Parma
Parma
Fondazione Salvatore Maugeri
Pavia
Policlinico San Mattea
Pavia
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia
Azienda Usl 7; Dept. Oncologico
Poggibonsi
Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica
Ponderano (bi)
Nuovo Ospedale Di Prato
Prato
Ospedale degli Infermi
Rimini
Policlinico Universitario Campus Biomedico Di Roma
Rome
Istituto Clinico Humanitas
Rozzano (mi)
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
Udine
Japan
Aichi Cancer Center Hospital
Aichi
Chiba Cancer Center
Chiba
Shikoku Cancer Center
Ehime
National Hospital Organization Kyushu Cancer Center
Fukuoka
Hiroshima City Hiroshima Citizens Hospital
Hiroshima
National Hospital Organization Hokkaido Cancer Center
Hokkaido
Hyogo Medical University Hospital
Hyōgo
University of Tsukuba Hospital
Ibaraki
Sagara Hospital
Kagoshima
Kanagawa Cancer Center
Kanagawa
Tokai University Hospital
Kanagawa
Kyoto University Hospital
Kyoto
Fukushima Medical University Hospital
Miyagi
Okayama University Hospital
Okayama
Naha-nishi Clinic
Okinawa
National Hospital Organization Osaka National Hospital
Osaka
Osaka International Cancer Institute
Osaka
Saitama Cancer Center
Saitama
Saitama Medical University International Medical Center
Saitama
Shizuoka Cancer Center
Shizuoka
St. Luke's Internat. Hospital, Breast Surgical Oncology
Tokyo
The Cancer Institute Hospital of JFCR
Tokyo
Mexico
Iem-Fucam
D.f.
Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
Distrito Federal
Merida | Investigacion Clinica
Mérida
CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO
Mexico City
Centro Medico Dalinde
Mexico City
Health Pharma Professional Research
Mexico City
Centro Médico Zambrano Hellion
Monterrey
Centro de Investigacion Clinica de Oaxaca
Oaxaca City
Oncologico Potosino
San Luis Potosí City
Peru
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
Arequipa
Instituto Nacional de Enfermedades Neoplasicas
Lima
Oncosalud Sac; Oncología
Lima
Poland
Instytut MSF Sp. z o.o.
?ód?
MedPolonia
Poznan
Wielkopolskie Centrum Onkologi
Poznan
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy; Klinika Onkologii
Warsaw
Republic of Korea
Chungbuk National University Hospital
Cheongju-si
Soon Chun Hyang University Cheonan Hospital
Dongnam-gu, Cheonan-si
National Cancer Center
Goyang-si
CHA Bundang Medical Center
Gyeonggi-do
Gachon University Gil Medical Center
Incheon
Inha University Hospital
Incheon
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Ewha Womans University Mokdong Hospital
Seoul
Gangnam Severance Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Seoul St Mary's Hospital
Seoul
Severance Hospital; Yonsei University Health System
Seoul
Ajou University Hospital
Suwon
Ulsan University Hosiptal
Ulsan
Wonju Christian Hospital
Wŏnju
Romania
Filantropia Clinical Hospital; Gynecological Oncology
Bucharest
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala
Cluj-napoca
Centrul de Oncologie Sfantul Nectarie
Craiova
Russian Federation
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk
Evimed
Chelyabinsk
Regional Oncology Hospital
Irkutsk
Ivanovo Regional Oncology Dispensary
Ivanovo
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
Moscow
Medsi Clinic
Moscow
Moscow Clinical Scientific Center
Moscow
P.A. Herzen Oncological Inst. ; Oncology
Moscow
Nizhny Novgorod Regional Clinical Oncology Center
Nizhny Novgorod
Regional Oncology Dispensary; Dept of Chemotherapy
Novgorod Veliky
BIH at Omsk Region Clinical Oncology Dispensary, Outpatient clinic
Omsk
Pyatigorsky Oncologic Dispensary
Pyatigorsk
National Medical Research Center for Oncology
Rostov-on-don
EosMed LLC
Saint Petersburg
FBI Scientific Research Institute of Oncology n. a. N. N. Petrov
Saint Petersburg
LCC Center of Palliative Medicine - Devita
Saint Petersburg
LLC Strategic Medical Systems
Saint Petersburg
Private Healthcare Institution Clinical Hospital RZhD Medicine
Saint Petersburg
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint Petersburg
Multidisciplinary clinic Reaviz
Samara
Samara Regional Oncology Dispensary
Samara
Mordovia State University
Saransk
Regional Clinical Hospital
Saratov
Oncologica Dispensary #2
Sochi
Bashkirian Republican Clinical Oncology Dispensary
Ufa
SHI Volgograd Regional Clinical Oncological Dispensary#1
Volgograd
Regional Clinical Oncology Hospital
Yaroslavl
Singapore
National Cancer Centre
Singapore
National University Hospital; Medical Oncology
Singapore
Spain
Centro Oncologico de Galicia COG; Medical Oncology
A Coruña
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona
Hospital Universitario de Burgos
Burgos
Hospital San Pedro De Alcantara; Servicio de Oncologia
Cáceres
Hospital Provincial Castellón
Castellon De La Plana/castello De La Plana
Complejo Hospitalario de Jaen
Jaén
Hospital de Jerez
Jerez De La Frontera
Complejo Asistencial Universitario de Leon; Servicio de Oncologia
León
Centro Integral Oncológico Clara Campal Ensayos Clínicos START
Madrid
Hosp Univ Fundacion Alcorcon
Madrid
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid
Hospital Universitario de Fuenlabrada; Servicio de Oncologia
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia
Hospital Son Llatzer
Palma De Mallorca
Hospital Universitari Sant Joan de Reus; Planta baja, color lila
Reus
Hospital Universitario de Canarias;servicio de Oncologia
San Cristóbal De La Laguna
Hospital Infanta Sofia; Servico de Oncologia
San Sebastián De Los Reyes
Hospital General De Catalunya; Servicio de Oncologia
Sant Cugat Del Vallès
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago De Compostela
Hospital Quirón Sagrado Corazón
Seville
Consorci Hospitalari de Terrassa
Terrassa
Hospital Clinico Universitario de Valencia
Valencia
Hospital General Universitario de Valencia; Servicio de oncologia
Valencia
Instituto Valenciano Oncologia; Oncologia Medica
Valencia
Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología
Vigo
Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
Zaragoza
Switzerland
Hirslanden Medical Center - Tumorzentrum
Aarau
Centre Hospitalier Universitaire Vaudois - Lausanne
Lausanne
Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
Zurich
Taiwan
Chunghua Christian hospital
Changhua
E-Da Cancer Hospital; Hematology- Oncology Department
Kaoshiung
Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital
Kaoshiung City
Chi Mei Medical Center Liou Ying Campus
Liuying Township
National Cheng Kung University Hospital
Tainan
Mackay Memorial Hospital - Taipei Branch
Taipei
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Tri-Service General Hospital
Taipei
Chang Gung Medical Foundation Linkou Branch
Taoyuan
Thailand
Rajavithi Hospital; Division of Medical Oncology
Bangkok
Ramathibodi Hospital; Medicine/Oncology
Bangkok
Siriraj Hospital; Clinical Research Center, Pharmacy Department
Bangkok
Songklanagarind Hospital
Hat Yai
Srinagarind Hospital, Khon Kaen University
Khon Kaen
Lampang Cancer Hospital
Lampang
King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University
Patumwan
Turkey
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
Adana
Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi
Bursa
Izmir Ekonomi Universitesi Medical Park Hastanesi
Izmir
Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi
Mersin
Medikal Park Samsun
Samsun
Ukraine
Regional Oncology Center; Department of Mammology
Chernihiv
Chernivtsi Regional Clinical Oncology Dispensary
Chernivtsi
MI Clinical Oncological Dispensary of Dnipro Reg Council; chemotherapy department
Dnipro
City Clinical Hospital #4
Dnipropetrovsk
Municipal Institution Kirovograd Regional Oncology Dispensary
Kirovograd
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
Kryvyi Rih
Volyn Regional Oncology Dispensary
Lutsk
Lviv State Oncological Regional Treatment and Diagnostic Center
Lviv
Municipal Institution Odesa Regional Clinical Hospital
Odesa
Municipal Institution Odesa Regional Oncology Dispensary
Odesa
Sumy Reg. Clin. Oncological Dispensary; Thoracall Department
Sumy
CCCH City Oncological Center SHEI Uzhgorod NU
Uzhhorod
Transkarpathian Regional Oncology Clinic; Chemotherapy
Uzhhorod
Vinnytsya Regional Clinical Oncology Dispensary
Vinnytsia
Yulis Medical and Diagnostic Center
Zaporizhzhia
Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University
Zaporizhzhya
United Kingdom
NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
Edinburgh
Calderdale and Huddersfield NHS Foundation Trust
Huddersfield
Leeds Teaching Hosp NHS Trust;St James's Institute of Onc
Leeds
The Christie NHS Foundation Trust
Manchester
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham
University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital
Stoke-on-trent
Time Frame
Start Date: 2018-08-02
Completion Date: 2023-08-14
Participants
Target number of participants: 2199
Treatments
Experimental: Atezolizumab + Chemotherapy
Participants will receive atezolizumab (in combination with chemotherapy as described below) every 2 weeks for 10 doses, followed by atezolizumab maintenance therapy every 3 weeks to complete 1 year of treatment from the first dose~Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
Active_comparator: Chemotherapy
Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
Related Therapeutic Areas
Sponsors
Collaborators: Alliance Foundation Trials, LLC., Breast International Group, Frontier Science & Technology Research Foundation, Inc., Jules Bordet Institute
Leads: Hoffmann-La Roche