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 (IMpassion030)
July 29, 2024 updated by: Hoffmann-La Roche
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
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)
Study Overview
Status
Status
Terminated
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Interventional
Enrollment (Actual)
Enrollment
2199
Phase
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
Study Contact
- Name: Reference Study ID Number: WO39391 https://forpatients.roche.com/
- Phone Number: 888-662-6728 (U.S. and Canada)
- Email: global-roche-genentech-trials@gene.com
Study Locations
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Berazategui, Argentina, B1880BBF
- Centro de Oncologia e; Investigacion Buenos Aires - COIBA
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Ciudad Autonoma Buenos Aires, Argentina, C1284AEB
- Hospital Britanico de Buenos Aires
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Ciudad Autonoma Buenos Aires, Argentina, C1012AAR
- INSTITUTO DE INVESTIGACIONES METABOLICAS (IDIM); Oncology
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Cordoba, Argentina, X5004FHP
- Clinica Universitaria Reina Fabiola
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Jujuy, Argentina
- Fundacion Ars Medica
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La Rioja, Argentina, F5300COE
- Centro Oncologico Riojano Integral (CORI)
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Rosario, Argentina, S2000KZE
- Instituto de Oncología de Rosario
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San Miguel de Tucuman, Argentina, T4000IAK
- Centro Médico San Roque
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Viedma, Argentina, R8500ACE
- Centro de Investigacion Clinica - Clinica Viedma S.A.; Oncology Department
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New South Wales
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Darlinghurst, New South Wales, Australia, 2010
- St Vincent's Hospital Sydney
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Lismore, New South Wales, Australia, 2480
- Lismore Base Hospital
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Macquarie Park, New South Wales, Australia, 2113
- Macquarie University Hospital
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Wahroonga, New South Wales, Australia, 2076
- Sydney Adventist Hospital
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Queensland
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Auchenflower, Queensland, Australia, 4066
- Icon Cancer Care Wesley
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Chermside, Queensland, Australia, 4032
- Icon Cancer Foundation; Icon Cancer Care Chermside
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South Brisbane, Queensland, Australia, 4101
- Icon Cancer Care South Brisbane
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South Brisbane, Queensland, Australia, 4101
- Mater Hospital; Cancer Services
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Southport, Queensland, Australia, 4215
- Icon Cancer Foundation; Icon Cancer Care Southport
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Woolloongabba, Queensland, Australia, 4102
- Princess Alexandra Hospital; Cancer Trials Unit
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital; Cancer Centre
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Kurralta Park, South Australia, Australia, 5037
- Ashford Cancer Center Research
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash Medical Centre
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Heidelberg, Victoria, Australia, 3084
- Austin Hospital Olivia Newton John Cancer Centre
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Ringwood East, Victoria, Australia, 3135
- Maroondah Hospital; Breast Clinic
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Innsbruck, Austria, 6020
- Medical University Innsbruck; Frauenklinik Innsbruck, Dept Gyn
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Linz, Austria, 4010
- Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie
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Salzburg, Austria, 5020
- Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
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Vienna, Austria, 1090
- AKH - Medizinische Universität Wien; Department of Oncology
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Vöcklabruck, Austria, 4840
- Salzkammergut-Klinikum Voecklabruck
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Wels, Austria, 4600
- Klinikum Kreuzschwestern Wels; Iv. Interne Abt.
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Wien, Austria, 1090
- Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
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Brasschaat, Belgium, 2930
- AZ KLINA
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Bruxelles, Belgium, 1000
- Institut Jules Bordet
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Leuven, Belgium, 3000
- UZ Leuven Gasthuisberg
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Liege, Belgium, 4000
- CHC MontLégia
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Liège, Belgium, 4000
- CHR de la Citadelle
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Mons, Belgium, 7000
- CHU Ambroise Pare
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Namur, Belgium, 5000
- Clinique Sainte-Elisabeth; Oncologie
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Sint Niklaas, Belgium, 9100
- Vitaz
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BA
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Salvador, Bahia, BA, Brazil, 40170-380
- Nucleo de Oncologia da Bahia - NOB
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CE
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Fortaleza, CE, Brazil, 60336-232
- Crio - Centro Regional Integrado de Oncologia
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RJ
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Rio de Janeiro, RJ, Brazil, 20560-120
- Instituto Nacional de Cancer - INCa; Oncologia
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Volta Redonda, RJ, Brazil, 27251-260
- Hospital Jardim Amália
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RS
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Ijui, RS, Brazil, 98700-000
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
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Porto Alegre, RS, Brazil, 90035-903
- Hospital das Clinicas - UFRGS
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Porto Alegre, RS, Brazil, 90035-001
- Hospital Moinhos de Vento
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Porto Alegre, RS, Brazil, 90110-000
- Hospital Mae de Deus
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SC
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Itajai, SC, Brazil, 88301-220
- Clinica de Neoplasias Litoral
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SP
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Barretos, SP, Brazil, 14784-400
- Hospital de Cancer de Barretos
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JAU, SP, Brazil, 17210-080
- Hospital Amaral Carvalho
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Santo Andre, SP, Brazil, 09060-650
- Faculdade de Medicina do ABC - FMABC
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Sao Paulo, SP, Brazil, 04014-002
- Instituto Brasileiro de Controle Do Câncer ? São Camilo Oncologia
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São Paulo, SP, Brazil, 01246 000
- Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
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Beijing, China, 100044
- Peking University People's Hospital
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Beijing, China, 100730
- Beijing Union Hospital
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Beijing, China, 100730
- Beijing Hospital; Internal Medicine-Oncology
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Changchun, China, 132013
- Jilin Cancer Hospital
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Changchun City, China, 130021
- The First Hospital of Jilin University
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Chengdu, China, 610041
- West China Hospital, Sichuan University
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Chongqing, China, 400030
- Chongqing Cancer Hospital
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Fuzhou, China, 110016
- The 900th Hospital of PLA joint service support force
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Fuzhou City, China, 350001
- Fujian Medical University Union Hospital
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Guangzhou, China, 510080
- Guangdong General Hospital
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Guangzhou, China, 510060
- Sun yat-sen University Cancer Center; Internal Medicine of Oncology
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Guangzhou, China
- Sun Yat-Sen University Cancer Center - Huangpu Campus
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Hangzhou, China, 310009
- The Second Affiliated Hospital of Zhejiang University College
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Hangzhou, China, 310003
- The First Affiliated Hospital of College of Medicine, Zhejiang University
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Harbin, China, 150081
- Harbin Medical University Cancer Hospital
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Jinan, China, 250117
- Shandong Cancer Hospital
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Luoyang City, China, 471000
- Luoyang Central Hospital
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Nanjing City, China, 210008
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
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Shanghai, China, 200025
- Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
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Shanghai, China, 200032
- Zhongshan Hospital Fudan University
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Shanghai City, China, 200120
- Fudan University Shanghai Cancer Center
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Shenzhen City, China, 518053
- The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee
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Shijiazhuang, China, 050035
- Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
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Wuhan, China, 430079
- Hubei Cancer Hospital
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Wuhan City, China, 430022
- Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
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Xi'an City, China, 710061
- The First Affiliated Hospital of Xian Jiao Tong University
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Zhejiang, China, 310022
- Zhejiang Cancer Hospital
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Zhengzhou, China, 450008
- Henan Cancer Hospital
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Horovice, Czechia, 26831
- Nemocnice Horovice, NH Hospital a.s.; Oncology Department
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Praha 2, Czechia, 128 08
- Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
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Zlin, Czechia, 76001
- Krajska nemocnice T. Bati, a.s.
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Herlev, Denmark, 2730
- Herlev Hospital; Afdeling for Kræftbehandling
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Odense C, Denmark, 5000
- Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed
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Vejle, Denmark, 7100
- Sygehus Lillebælt, Vejle
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Ars-Laquenexy, France, 57530
- Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy
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Avignon, France, 84082
- Institut Sainte Catherine
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Beauvais, France, 60000
- CH de BEAUVAIS
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Besançon, France, 25030
- Chu Jean Minjoz
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Bordeaux, France, 33300
- Polyclinique Bordeaux Nord Aquitaine
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Bordeaux, France, 33000
- Clinique Tivoli; Sce Radiotherapie
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Bourg-en- Bresse Cedex, France, 01012
- Centre Hospitalier Fleyriat
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Brest, France, 29609
- CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie
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Caen, France, 14076
- CRLCC-Francois Baclesse; Oncologie Médicale
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Cholet, France, 49325
- CH de Cholet; oncologie
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Compiegne, France, 60321
- Centre Hospitalier de Compiegne
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Contamine Sur Arve, France, 74130
- Centre Hospitalier Alpes Leman
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Dijon, France, 21000
- Centre Georges François Leclerc
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La Roche Sur Yon, France, 85925
- Centre Hospitalier Départemental de Vendée
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Limoges, France, 87039
- Clinique Chenieux; Oncology
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Lorient, France, 56100
- Centre Hospitalier Bretagne Sud
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Lyon, France, 69008
- Hopital Prive Jean Mermoz
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Marseille, France, 13008
- Hopital Saint Joseph
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Montpellier, France, 34298
- Institut régional du Cancer Montpellier
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Montpellier, France, 34070
- Clinique Clémentville
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Nantes, France, 44202
- l'Hôpital privé du Confluent SAS
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Nice, France, 06189
- Centre Antoine Lacassagne
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Pringy, France, 74374
- CH Annecy Genevois site Annecy; Oncologie
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Quimper, France, 29107
- Chi De Cornouaille; Oncologie Hospitalisation
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Reims, France, 51056
- Institut Jean Godinot
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Reims, France, 51100
- Institut du Cancer Coulancy Reims
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Rouen, France, 76038
- Centre Henri Becquerel
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St Priest en Jarez CEDEX, France, 42271
- Institut De Cancerologie Lucien Newrth
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Strasbourg, France, 67000
- Centre Paul Strauss
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Thonon Les Bains, France, 74200
- Hopitaux Du Leman - Site Georges Pianta
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Toulouse, France, 31059
- Institut Claudius Regaud
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Tours, France, 37044
- CHU Tours - Hôpital Bretonneau
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Valence, France, 26000
- Hopital Prive Drome Ardeche; Hopital De Jour
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Vandoeuvre-Les-Nancy, France, 54519
- Institut de Cancerologie de Lorraine
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Villejuif, France, 94805
- Institut Gustave Roussy; Departement Oncologie Medicale
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Berlin, Germany, 14169
- Studienzentrum Berlin City
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Dortmund, Germany, 44137
- St. Johannes-Hospital
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Dresden, Germany, 01127
- Onkozentrum Dres. Göhler
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Dresden, Germany, 01307
- BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
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Erfurt, Germany, 99085
- Praxis fur Hamatologie und Onkologie
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Gütersloh, Germany, 33332
- Onkodok GmbH
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Hamburg, Germany, 22457
- Albertinen-Krankenhaus Klinik f.Gynäkologie und Geburtshilfe
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Hildesheim, Germany, 31134
- Ärztehaus am Bahnhofsplatz; Praxis Uleer/Pourfard
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Karlsruhe, Germany, 76135
- ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik
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Köln, Germany, 50935
- St. Elisabeth-Krankenhaus
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Ludwigsburg, Germany, 71640
- Klinikum Ludwigsburg; Studiensekretariat
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Mainz, Germany, 55131
- Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
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Mainz, Germany, 55131
- St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz
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Mayen, Germany, 56727
- Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller
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Memmingen, Germany, 87700
- Klinikum Memmingen; Abt.Gynäkologie
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Minden, Germany, 32429
- Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin
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Mönchengladbach, Germany, 41061
- Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
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München, Germany, 80336
- Klinikum der Universität München; Frauenklinik - Onkologie II
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Neumarkt i.d.OPf., Germany, 92318
- Klinikum Neumarkt; Frauenklinik
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Offenbach, Germany, 63069
- Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
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Stendal, Germany, 39676
- Johanniter Frauenklinik Stendal Germany
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Stralsund, Germany, 18439
- Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
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Tübingen, Germany, 72076
- Universitätsklinik Tübingen; Frauenklinik
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Weinheim, Germany, 69469
- GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe
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Witten, Germany, 58452
- Marien-Hospital Witten, MVZ Witten
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Worms, Germany, 67550
- Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe
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Hong Kong, Hong Kong
- Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
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Hong Kong, Hong Kong, 999077
- Queen Mary Hospital
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Kowloon, Hong Kong
- Queen Elizabeth Hospital Department of Clinical Oncology
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Budapest, Hungary, 1122
- National Institute of Oncology, A Dept of Internal Medicine
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Miskolc, Hungary, 3526
- Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
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Pécs, Hungary, 7623
- Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
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Dublin, Ireland, 7
- Mater Misecordiae University Hospital
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Dublin, Ireland, 9
- Beaumont Hospital; Cancer Clinical Trials Unit
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Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
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Jerusalem, Israel, 9112000
- Hadassah Med Org Kiryat; Oncology Institute
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Kfar Sava, Israel, 4428164
- Meir Medical center, Pediatrics
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Petach Tikva, Israel, 4941492
- Rabin MC; Davidof Center - Oncology Institute
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Ramat Gan, Israel, 5211401
- The Chaim Sheba Medical Center
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Abruzzo
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Bergamo, Abruzzo, Italy, 24060
- Azienda Ospedaliera Papa Giovanni XXIII
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italy, 40138
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi; UO Farmacia Clinica
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Carpi, Emilia-Romagna, Italy, 41012
- U.O Medicina Oncologica Ospedale di Carpi
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Faenza, Emilia-Romagna, Italy, 48018
- Ospedale Degli Infermi - Faenza; Oncologia Medica
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Modena, Emilia-Romagna, Italy, 41110
- Azienda Ospedaliero - Universitaria di Modena Policlinico
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Parma, Emilia-Romagna, Italy, 43126
- Azienda Ospedaliero Universitaria di Parma
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Rimini, Emilia-Romagna, Italy, 47923
- Ospedale degli Infermi
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Friuli-Venezia Giulia
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Udine, Friuli-Venezia Giulia, Italy, 33100
- A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
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Lazio
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Roma, Lazio, Italy, 00128
- Policlinico Universitario Campus Biomedico Di Roma
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Liguria
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Genova, Liguria, Italy, 16132
- Azienda Ospedaliero Universitaria San Martino
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Lombardia
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Lecco, Lombardia, Italy, 23900
- ASST DI LECCO; Oncologia Medica
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Legnago (VR), Lombardia, Italy, 37045
- Ospedale Mater Salutis
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Milano, Lombardia, Italy, 20141
- Istituto Europeo Di Oncologia
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Pavia, Lombardia, Italy, 27100
- Fondazione Salvatore Maugeri
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Pavia, Lombardia, Italy, 27100
- Policlinico San Mattea
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Rozzano (MI), Lombardia, Italy, 20089
- Istituto Clinico Humanitas
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Piemonte
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Alessandria, Piemonte, Italy, 15121
- Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
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Ponderano (BI), Piemonte, Italy, 13875
- Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica
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Toscana
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Bagno a Ripoli, Toscana, Italy, 50012
- Ospedale Santa Maria Annunziata; Oncologia
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Poggibonsi, Toscana, Italy, 53036
- Azienda Usl 7; Dept. Oncologico
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Prato, Toscana, Italy, 50047
- Nuovo Ospedale di Prato
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Umbria
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Perugia, Umbria, Italy, 06100
- Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia
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Aichi, Japan, 464-8681
- Aichi Cancer Center Hospital
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Chiba, Japan, 260-8717
- Chiba Cancer Center
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Ehime, Japan, 791-0280
- Shikoku Cancer Center
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Fukuoka, Japan, 811-1395
- National Hospital Organization Kyushu Cancer Center
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Hiroshima, Japan, 730-8518
- Hiroshima City Hiroshima Citizens Hospital
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Hokkaido, Japan, 003-0804
- National Hospital Organization Hokkaido Cancer Center
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Hyogo, Japan, 663-8501
- Hyogo Medical University Hospital
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Ibaraki, Japan, 305-8576
- University of Tsukuba Hospital
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Kagoshima, Japan, 892-0833
- Sagara Hospital
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Kanagawa, Japan, 241-8515
- Kanagawa Cancer Center
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Kanagawa, Japan, 259-1193
- Tokai University Hospital
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Kyoto, Japan, 606-8507
- Kyoto University Hospital
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Miyagi, Japan, 960-1295
- Fukushima Medical University Hospital
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Okayama, Japan, 700-8558
- Okayama University Hospital
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Okinawa, Japan, 901-0154
- Naha-nishi Clinic
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Osaka, Japan, 540-0006
- National Hospital Organization Osaka National Hospital
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Osaka, Japan, 541-8567
- Osaka International Cancer Institute
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Saitama, Japan, 350-1298
- Saitama Medical University International Medical Center
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Saitama, Japan, 362-0806
- Saitama Cancer Center
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Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
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Tokyo, Japan, 104-8560
- St. Luke's Internat. Hospital, Breast Surgical Oncology
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Tokyo, Japan, 135-8550
- The Cancer Institute Hospital Of JFCR
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Cheongju si, Korea, Republic of, 28644
- Chungbuk National University Hospital
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Dongnam-gu, Cheonan-si, Korea, Republic of, 31151
- Soon Chun Hyang University Cheonan Hospital
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Goyang-si, Korea, Republic of, 10408
- National Cancer Center
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Gyeonggi-do, Korea, Republic of, 13496
- CHA Bundang Medical Center
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Incheon, Korea, Republic of, 21565
- Gachon University Gil Medical Center
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Incheon, Korea, Republic of, 22332
- Inha University Hospital
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Seongnam-si, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Seoul, Korea, Republic of, 05505
- Asan Medical Center
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Seoul, Korea, Republic of, 07985
- Ewha Womans University MokDong Hospital
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
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Seoul, Korea, Republic of, 06273
- Gangnam Severance Hospital
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Seoul, Korea, Republic of, 06591
- Seoul St Mary's Hospital
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Seoul, Korea, Republic of, 03722
- Severance Hospital; Yonsei University Health System
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Suwon City, Korea, Republic of, 443-721
- Ajou University Hospital
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Ulsan, Korea, Republic of, 44033
- Ulsan University Hosiptal
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Wonju, Korea, Republic of, 220-701
- Wonju Christian Hospital
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Mexico City, Mexico, 06700
- Centro Medico Dalinde
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Mexico City, Mexico, 03100
- CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO
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Mexico CITY (federal District)
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Cdmx, Mexico CITY (federal District), Mexico, 03100
- Health Pharma Professional Research
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D.f., Mexico CITY (federal District), Mexico, 04980
- Iem-Fucam
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Distrito Federal, Mexico CITY (federal District), Mexico, 14000
- Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
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Nuevo LEON
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Monterrey, Nuevo LEON, Mexico, 66278
- Centro Medico Zambrano Hellion
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Oaxaca
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Oaxaca de Juárez, Oaxaca, Mexico, 68020
- Centro de Investigacion Clinica de Oaxaca
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SAN LUIS Potosi
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San Luis Potosí, SAN LUIS Potosi, Mexico, 78209
- Oncologico Potosino
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Yucatan
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Mérida, Yucatan, Mexico, 97125
- Merida | Investigacion Clinica
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Arequipa, Peru, 04001
- Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
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Lima, Peru, 41
- Oncosalud Sac; Oncología
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Lima, Peru, 15038
- Instituto Nacional de Enfermedades Neoplasicas
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?ód?, Poland, 90-302
- Instytut MSF Sp. z o.o.
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Poznan, Poland, 60-693
- MedPolonia
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Poznan, Poland, 61-866
- Wielkopolskie Centrum Onkologi
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Warszawa, Poland, 00-909
- Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy; Klinika Onkologii
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Bucharest, Romania, 011191
- "Filantropia" Clinical Hospital; Gynecological Oncology
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Cluj Napoca, Romania, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala
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Craiova, Romania, 200347
- Centrul de Oncologie Sfantul Nectarie
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Irkutsk, Russian Federation, 664035
- Regional Oncology Hospital
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Ivanovo, Russian Federation, 153040
- Ivanovo regional oncology dispensary
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Novgorod Veliky, Russian Federation, 173016
- Regional Oncology Dispensary; Dept of Chemotherapy
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Omsk, Russian Federation, 644013
- BIH at Omsk Region "Clinical Oncology Dispensary", Outpatient clinic
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Samara, Russian Federation, 443031
- Samara Regional Oncology Dispensary
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Samara, Russian Federation, 443011
- Multidisciplinary clinic Reaviz
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Saratov, Russian Federation, 410053
- Regional Clinical Hospital
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Volgograd, Russian Federation, 400138
- SHI Volgograd Regional Clinical Oncological Dispensary#1
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Adygeja
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Moscow, Adygeja, Russian Federation, 143442
- MEDSI Clinic
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Arhangelsk
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Arkhangelsk, Arhangelsk, Russian Federation, 163045
- Arkhangelsk Regional Clinical Oncology Dispensary
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Baskortostan
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UFA, Baskortostan, Russian Federation, 450054
- Bashkirian Republican Clinical Oncology Dispensary
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Jaroslavl
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Yaroslavl, Jaroslavl, Russian Federation, 150054
- Regional Clinical Oncology Hospital
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Krasnodar
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Sochi, Krasnodar, Russian Federation, 354057
- Oncologica Dispensary #2
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Kurgan
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Chelyabinsk, Kurgan, Russian Federation
- Evimed
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Mordovija
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Saransk, Mordovija, Russian Federation, 430032
- Mordovia State University
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Moskovskaja Oblast
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Moscow, Moskovskaja Oblast, Russian Federation, 111123
- Moscow Clinical Scientific Center
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Moscow, Moskovskaja Oblast, Russian Federation, 115478
- FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
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Moscow, Moskovskaja Oblast, Russian Federation, 125248
- P.A. Herzen Oncological Inst. ; Oncology
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Niznij Novgorod
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Nizhny Novgorod, Niznij Novgorod, Russian Federation, 603126
- Nizhny Novgorod Regional Clinical Oncology Center
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Rostov
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Rostov-na-donu, Rostov, Russian Federation, 344037
- National Medical Research Center for Oncology
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Sankt Petersburg
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Saint-Petersburg, Sankt Petersburg, Russian Federation, 197758
- S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
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Saint-Petersburg, Sankt Petersburg, Russian Federation
- FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
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Sankt-peterburg, Sankt Petersburg, Russian Federation, 194291
- LLC Strategic Medical Systems
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Sankt-peterburg, Sankt Petersburg, Russian Federation, 195197
- EosMed LLC
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Sankt-peterburg, Sankt Petersburg, Russian Federation, 197343
- LCC Center of Palliative Medicine - Devita
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St. Petersburg, Sankt Petersburg, Russian Federation, 195271
- Private Healthcare Institution Clinical Hospital RZhD Medicine
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Stavropol
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Pyatigorsk, Stavropol, Russian Federation, 357524
- Pyatigorsky Oncologic Dispensary
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Singapore, Singapore, 169610
- National Cancer Centre
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Singapore, Singapore, 119074
- National University Hospital; Medical Oncology
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Burgos, Spain, 09006
- Hospital Universitario de Burgos
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Caceres, Spain, 10003
- Hospital San Pedro De Alcantara; Servicio de Oncologia
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Jaen, Spain, 23007
- Complejo Hospitalario de Jaén
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Leon, Spain, 24071
- Complejo Asistencial Universitario de Leon; Servicio de Oncologia
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Madrid, Spain, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre; Servicio de Oncologia
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Madrid, Spain, 28050
- Centro Integral Oncológico Clara Campal Ensayos Clínicos START
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Madrid, Spain, 28922
- Hosp Univ Fundacion Alcorcon
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Madrid, Spain, 28943
- Hospital Universitario de Fuenlabrada; Servicio de Oncologia
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Madrid, Spain, 28009
- Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
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Malaga, Spain, 29010
- Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
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Murcia, Spain, 30120
- Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
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Sevilla, Spain, 41013
- Hospital Quiron Sagrado Corazon
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Valencia, Spain, 46010
- Hospital Clinico Universitario de Valencia
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Valencia, Spain, 46009
- Instituto Valenciano Oncologia; Oncologia Medica
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Valencia, Spain, 46014
- Hospital General Universitario de Valencia; Servicio de oncologia
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Zaragoza, Spain, 50009
- Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
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Sant Cugat Del Valles, Barcelona, Spain, 28981
- Hospital General De Catalunya; Servicio de Oncologia
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Terrassa, Barcelona, Spain, 08227
- Consorci Hospitalari de Terrassa
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Cadiz
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Jerez De La Frontera, Cadiz, Spain, 11407
- Hospital de Jerez
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Castellon
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Castellon DE LA Plana/castello DE LA Plana, Castellon, Spain, 12002
- Hospital Provincial Castellón
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Islas Baleares
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Palma de Mallorca, Islas Baleares, Spain, 07198
- Hospital Son Llatzer
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LA Coruña
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A Coruna, LA Coruña, Spain, 15009
- Centro Oncologico de Galicia COG; Medical Oncology
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Santiago de Compostela, LA Coruña, Spain, 15706
- Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
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Madrid
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Majadahonda, Madrid, Spain, 28220
- Hospital Universitario Puerta de Hierro - Majadahonda
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San Sebastian de Los Reyes, Madrid, Spain, 28702
- Hospital Infanta Sofia; Servico de Oncologia
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Pontevedra
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Vigo, Pontevedra, Spain, 36312
- Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología
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Tarragona
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Reus, Tarragona, Spain, 43204
- Hospital Universitari Sant Joan de Reus; Planta baja, color lila
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Tenerife
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La Laguna, Tenerife, Spain, 38320
- Hospital Universitario de Canarias;servicio de Oncologia
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Aarau, Switzerland, 5000
- Hirslanden Medical Center - Tumorzentrum
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Lausanne, Switzerland, 1011
- Centre Hospitalier Universitaire Vaudois - Lausanne
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Zürich, Switzerland, 8008
- Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
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Changhua, Taiwan, 500
- Chunghua Christian hospital
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Kaoshiung, Taiwan, 824
- E-Da Cancer Hospital; Hematology- Oncology Department
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Kaoshiung City, Taiwan, 807
- Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital
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Liuying Township, Taiwan, 736
- Chi Mei Medical Center Liou Ying Campus
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Tainan, Taiwan, 70457
- National Cheng Kung University Hospital
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Taipei, Taiwan, 11490
- Tri-Service General Hospital
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Taipei, Taiwan, 104
- Mackay Memorial Hospital - Taipei Branch
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Taipei City, Taiwan, 112
- Taipei Veterans General Hospital
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Taoyuan City, Taiwan, 333
- Chang Gung Medical Foundation Linkou Branch
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Bangkok, Thailand, 10400
- Rajavithi Hospital; Division of Medical Oncology
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Bangkok, Thailand, 10400
- Ramathibodi Hospital; Medicine/Oncology
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Bangkok, Thailand, 10700
- Siriraj Hospital; Clinical Research Center, Pharmacy Department
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Hat Yai, Thailand, 90110
- Songklanagarind Hospital
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Khon Kaen, Thailand, 40002
- Srinagarind Hospital, Khon Kaen University
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Muang Lampang, Thailand, 52000
- Lampang Cancer Hospital
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Patumwan, Thailand, 10330
- King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University
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Adana, Turkey, 01240
- Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
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Bursa, Turkey, 16059
- Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi
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Izmir, Turkey, 35575
- Izmir Ekonomi Universitesi Medical Park Hastanesi
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Mersin, Turkey, 33110
- Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi
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Samsun, Turkey, 55200
- Medikal Park Samsun
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Chernigiv, Ukraine, 14029
- Regional Oncology Center; Department of Mammology
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Chernivtsi, Ukraine, 58013
- Chernivtsi Regional Clinical Oncology Dispensary
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Dnipropetrovsk, Ukraine, 49102
- City Clinical Hospital #4
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Kirovograd, Ukraine, 25011
- Municipal Institution Kirovograd Regional Oncology Dispensary
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Kryvyi Rih, Ukraine, 50048
- ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
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Lutsk, Ukraine, 43018
- Volyn Regional Oncology Dispensary
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Lviv, Ukraine, 79031
- Lviv State Oncological Regional Treatment and Diagnostic Center
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Odesa, Ukraine, 65025
- Municipal Institution Odesa Regional Clinical Hospital
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Sumy, Ukraine, 40005
- Sumy Reg. Clin. Oncological Dispensary; Thoracall Department
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Uzhgorod, Ukraine, 88000
- CCCH City Oncological Center SHEI Uzhgorod NU
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Uzhgorod, Ukraine, 88000
- Transkarpathian Regional Oncology Clinic; Chemotherapy
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Zaporizhzhya, Ukraine, 69040
- Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University
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KIEV Governorate
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Dnipro, KIEV Governorate, Ukraine, 49100
- MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department
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Odesa, KIEV Governorate, Ukraine, 65055
- Municipal Institution Odesa Regional Oncology Dispensary
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Katerynoslav Governorate
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Zaporizhzhia, Katerynoslav Governorate, Ukraine, 69061
- Yulis Medical and Diagnostic Center
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Podolia Governorate
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Vinnytsya, Podolia Governorate, Ukraine, 21029
- Vinnytsya Regional Clinical Oncology Dispensary
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Edinburgh, United Kingdom, EH4 2XU
- NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
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Huddersfield, United Kingdom, HD3 3EA
- Calderdale and Huddersfield NHS Foundation Trust
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Leeds, United Kingdom, LS9 7TF
- Leeds Teaching Hosp NHS Trust;St James's Institute of Onc
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Manchester, United Kingdom, M20 4BX
- The Christie NHS Foundation Trust
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Nottingham, United Kingdom, NG5 1PB
- Nottingham University Hospitals NHS Trust - City Hospital
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Stoke-On-Trent, United Kingdom, ST4 6QG
- University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital
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California
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Concord, California, United States, 94520
- John Muir Health Clinical Research Center
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Saint Helena, California, United States, 94574
- Martin-O?Neil Cancer Center
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Florida
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Jacksonville, Florida, United States, 32207
- Baptist - MD Anderson Cancer Center
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Illinois
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Chicago, Illinois, United States, 60657
- Advocate Illinois Masonic Outpatient Center for Advanced Care
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Iowa
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Des Moines, Iowa, United States, 50309
- Des Moines Oncology Research Association
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Kansas
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Wichita, Kansas, United States, 67214-3728
- Cancer Center of Kansas
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Greenebaum Comprehensive Cancer Center
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Minnesota
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Edina, Minnesota, United States, 55435
- Fairview Southdale Medical Oncology Clinic
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Missouri
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Kansas City, Missouri, United States, 64132
- HCA Midwest Division
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New Hampshire
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Manchester, New Hampshire, United States, 03103
- New Hampshire Hematology Oncology
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New York
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Lake Success, New York, United States, 11042
- Monter Cancer Center
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New York, New York, United States, 11101
- Memorial Sloan Kettering Cancer Center
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Rochester, New York, United States, 14621
- Rochester General Hospital; Lipson Cancer and Blood Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- SCRI
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Utah
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Saint George, Utah, United States, 84770
- Intermountain Precision Genomics Cancer Research Clinic-Dixie
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West Virginia
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Huntington, West Virginia, United States, 25702
- St. Mary's Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
2
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
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) |
Atezolizumab will be administered by IV, 840 mg every 2 weeks, for 10 doses. Atezolizumab maintenance will be administered by IV, 1200 mg every 3 weeks to complete 1 year
Paclitaxel will be administered by IV, 80 mg/m^2 every week for 12 weeks.
Dose-dense doxorubicin will be administered by IV, 60 mg/m^2 every 2 weeks for a total of 4 doses. Or Dose-dense epirubicin will be administered by IV, (90 mg/m^2) every 2 weeks for a total of 4 doses
Cyclophosphamide will be administered by IV, 600 mg/m^2 every 2 weeks for 4 doses
|
|
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)
|
Paclitaxel will be administered by IV, 80 mg/m^2 every week for 12 weeks.
Dose-dense doxorubicin will be administered by IV, 60 mg/m^2 every 2 weeks for a total of 4 doses. Or Dose-dense epirubicin will be administered by IV, (90 mg/m^2) every 2 weeks for a total of 4 doses
Cyclophosphamide will be administered by IV, 600 mg/m^2 every 2 weeks for 4 doses
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Invasive Disease-Free Survival (iDFS)
Time Frame: From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
|
iDFS was defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, &/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site [other than the sites mentioned]) that has either been histologically confirmed &/or clinically/radiographically diagnosed as recurrent invasive breast cancer; & Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause.
Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
|
From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3)
Time Frame: From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
|
iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer, Contralateral invasive breast cancer, Distant recurrence (i.e., evidence of breast cancer in any anatomic site [other than the sites mentioned]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause.
Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
|
From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
|
|
Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation
Time Frame: From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
|
iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site [other than the sites mentioned]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer; and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause.
Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
|
From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
|
|
Overall Survival (OS)
Time Frame: From randomization up to death from any cause (up to 5 years)
|
Overall Survival (OS) is defined as the time from randomization to the date of death due to any cause.
Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
|
From randomization up to death from any cause (up to 5 years)
|
|
Invasive Disease-Free Survival (iDFS) Including Second Primary Non-Breast Invasive Cancer
Time Frame: From randomization up to death from any cause (up to 5 years)
|
iDFS = the time from randomization until the date of first occurrence of one of the events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in axilla, regional lymph nodes, chest wall, &/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Second primary non-breast invasive cancer; Contralateral invasive breast cancer; Distant recurrence (i.e., evidence of breast cancer in any anatomic site [other than sites mentioned]) that has either been histologically confirmed &/or clinically/radiographically diagnosed as recurrent invasive breast cancer; Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause.
Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
|
From randomization up to death from any cause (up to 5 years)
|
|
Recurrence-Free Interval (RFI)
Time Frame: From randomization up to 5 years
|
Recurrence-Free Interval (RFI) was defined as the time from randomization to the first occurrence of any recurrence (local, regional [including invasive ipsilateral tumor and invasive locoregional tumor], or distant), as determined by investigators.
Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored.
|
From randomization up to 5 years
|
|
Distant Recurrence-Free Interval (DRFI)
Time Frame: From randomization up to 5 years
|
Distant Recurrence-Free Interval (DRFI) was defined as the time from randomization to the distant breast cancer recurrence.
Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored.
|
From randomization up to 5 years
|
|
Disease-Free Survival (DFS)
Time Frame: From randomization up to first disease recurrence or death from any cause (up to 5 years)
|
Disease-Free Survival (DFS) was defined as the time from randomization to the first occurrence of disease recurrence or death from any cause.
DFS events include: Ipsilateral invasive breast tumor recurrence; Ipsilateral local-regional invasive breast cancer recurrence; Distant recurrence that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS; Second primary non-breast invasive cancer; Death attributable to any cause.
Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
|
From randomization up to first disease recurrence or death from any cause (up to 5 years)
|
|
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])
Time Frame: 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
|
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire.
For the role functioning scale, participant responses to the 2 questions "Q6: Were you limited in doing either your work or daily activities" and "Q7: Were you limited in pursuing your hobbies or other leisure time activities" were scored on a 4-point scale (1=Not at All to 4=Very Much).
The scores were linearly transformed on a scale of 0 to 100, with a low score indicating better functioning.
Negative change from baseline indicated improvement.
|
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
|
|
Change From Baseline in EORTC QLQ-C30 Patient-reported Function (Physical Functioning [Q1-Q5])
Time Frame: 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
|
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire.
For the physical functioning scale, participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest & needing help with eating, dressing, washing themselves, or using the toilet) were scored on a 4-point scale (1=Not at All to 4=Very Much).
The scores were linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning.
Negative change from baseline indicated improvement in functioning.
|
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
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status (GHS) [Q29] and Health-Related Quality of Life (HRQoL) [Q30] Combined Score
Time Frame: 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
|
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire.
Participant responses to the questions regarding Global Health Status (Q29:GHS; "How would you rate your overall health during the past week?")
and Quality of Life (Q30: QoL; "How would you rate your overall quality of life during the past week?")
are scored on a 7-point scale (1= Very poor to 7=Excellent).
Using linear transformation, raw scores are standardized, so that scores range from 0 to 100.
A higher score indicates a better outcome.
Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.
|
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
|
|
Number of Participants With Adverse Events (AE)
Time Frame: Up to 5 years
|
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Preexisting conditions which worsen during a study are also considered as adverse events.
AEs are reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
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Up to 5 years
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Serum Concentration of Atezolizumab
Time Frame: 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
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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
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Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Time Frame: Up to 5 years
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Baseline evaluable participant= participant with an ADA assay result from a baseline sample(s).
Post-baseline evaluable participant= participant with an ADA assay result from at least one postbaseline sample.
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Up to 5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
Study Start
August 2, 2018
Primary Completion (Actual)
Primary Completion
August 14, 2023
Study Completion (Actual)
Study Completion
August 14, 2023
Study Registration Dates
First Submitted
First Submitted
February 28, 2018
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
April 12, 2018
First Posted (Actual)
First Posted
April 17, 2018
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
August 21, 2024
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
July 29, 2024
Last Verified
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Triple Negative Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Antibiotics, Antineoplastic
- Immune Checkpoint Inhibitors
- Cyclophosphamide
- Paclitaxel
- Epirubicin
- Doxorubicin
- Atezolizumab
Other Study ID Numbers
Other Study ID Numbers
- WO39391
- 2016-003695-47 (EudraCT Number)
- BIG 16-05 (Other Identifier: Breast International Group (BIG))
- AFT-27 (Other Identifier: Alliance Foundation Trials)
- ALEXANDRA (Other Identifier: Breast International Group (BIG))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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