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
NCT ID: NCT03498716
Last Updated: 2024-08-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
2199 participants
INTERVENTIONAL
2018-08-02
2023-08-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer
NCT03197935
A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
NCT03125902
A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)
NCT02425891
A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer
NCT04177108
Atezolizumab and Cobimetinib or Idasanutlin in Participants With Stage IV or Unresectable Recurrent Estrogen Receptor Positive Breast Cancer
NCT03566485
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
Paclitaxel will be administered by IV, 80 mg/m\^2 every week for 12 weeks.
Dose-dense Doxorubicin or dose-dense Epirubicin
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
Cyclophosphamide will be administered by IV, 600 mg/m\^2 every 2 weeks for 4 doses
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
Paclitaxel will be administered by IV, 80 mg/m\^2 every week for 12 weeks.
Dose-dense Doxorubicin or dose-dense Epirubicin
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
Cyclophosphamide will be administered by IV, 600 mg/m\^2 every 2 weeks for 4 doses
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Atezolizumab
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
Paclitaxel will be administered by IV, 80 mg/m\^2 every week for 12 weeks.
Dose-dense Doxorubicin or dose-dense Epirubicin
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
Cyclophosphamide will be administered by IV, 600 mg/m\^2 every 2 weeks for 4 doses
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Breast International Group
OTHER
Alliance Foundation Trials, LLC.
OTHER
Jules Bordet Institute
OTHER
Frontier Science & Technology Research Foundation, Inc.
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
John Muir Health Clinical Research Center
Concord, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Martin-O?Neil Cancer Center
St. Helena, California, United States
Baptist - MD Anderson Cancer Center
Jacksonville, Florida, United States
Advocate Illinois Masonic Outpatient Center for Advanced Care
Chicago, Illinois, United States
Des Moines Oncology Research Association
Des Moines, Iowa, United States
Cancer Center of Kansas
Wichita, Kansas, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Fairview Southdale Medical Oncology Clinic
Edina, Minnesota, United States
HCA Midwest Division
Kansas City, Missouri, United States
New Hampshire Hematology Oncology
Manchester, New Hampshire, United States
Monter Cancer Center
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Rochester General Hospital; Lipson Cancer and Blood Center
Rochester, New York, United States
SCRI
Nashville, Tennessee, United States
Intermountain Precision Genomics Cancer Research Clinic-Dixie
St. George, Utah, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Centro de Oncologia e; Investigacion Buenos Aires - COIBA
Berazategui, , Argentina
INSTITUTO DE INVESTIGACIONES METABOLICAS (IDIM); Oncology
Ciudad Autonoma Buenos Aires, , Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, , Argentina
Clinica Universitaria Reina Fabiola
Córdoba, , Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, , Argentina
Instituto de Oncología de Rosario
Rosario, , Argentina
Centro Medico San Roque
San Miguel de Tucumán, , Argentina
Fundación Ars Medica
San Salvador de Jujuy, , Argentina
Centro de Investigacion Clinica - Clinica Viedma S.A.; Oncology Department
Viedma, , Argentina
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Lismore Base Hospital
Lismore, New South Wales, Australia
Macquarie University Hospital
Macquarie Park, New South Wales, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia
Icon Cancer Care Wesley
Auchenflower, Queensland, Australia
Icon Cancer Foundation; Icon Cancer Care Chermside
Chermside, Queensland, Australia
Icon Cancer Care South Brisbane
South Brisbane, Queensland, Australia
Mater Hospital; Cancer Services
South Brisbane, Queensland, Australia
Icon Cancer Foundation; Icon Cancer Care Southport
Southport, Queensland, Australia
Princess Alexandra Hospital; Cancer Trials Unit
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital; Cancer Centre
Adelaide, South Australia, Australia
Ashford Cancer Center Research
Kurralta Park, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Austin Hospital Olivia Newton John Cancer Centre
Heidelberg, Victoria, Australia
Maroondah Hospital; Breast Clinic
Ringwood East, Victoria, Australia
Medical University Innsbruck; Frauenklinik Innsbruck, Dept Gyn
Innsbruck, , Austria
Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie
Linz, , Austria
Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
Salzburg, , Austria
AKH - Medizinische Universität Wien; Department of Oncology
Vienna, , Austria
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
Vienna, , Austria
Salzkammergut-Klinikum Voecklabruck
Vöcklabruck, , Austria
Klinikum Kreuzschwestern Wels; Iv. Interne Abt.
Wels, , Austria
AZ KLINA
Brasschaat, , Belgium
Institut Jules Bordet
Brussels, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
CHC MontLégia
Liège, , Belgium
Chr de La Citadelle
Liège, , Belgium
CHU Ambroise Paré
Mons, , Belgium
Clinique Sainte-Elisabeth; Oncologie
Namur, , Belgium
Vitaz
Sint-Niklaas, , Belgium
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil
Nucleo de Oncologia da Bahia - NOB
Salvador, Bahia, Estado de Bahia, Brazil
Instituto Nacional de Cancer - INCa; Oncologia
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Jardim Amália
Volta Redonda, Rio de Janeiro, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, Brazil
Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira
São Paulo, São Paulo, Brazil
Instituto Brasileiro de Controle Do Câncer ? São Camilo Oncologia
São Paulo, São Paulo, Brazil
Peking University People's Hospital
Beijing, , China
Beijing Hospital; Internal Medicine-Oncology
Beijing, , China
Beijing Union Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Jilin Cancer Hospital
Changchun, , China
West China Hospital, Sichuan University
Chengdu, , China
Chongqing Cancer Hospital
Chongqing, , China
The 900th Hospital of PLA joint service support force
Fuzhou, , China
Fujian Medical University Union Hospital
Fuzhou, , China
Sun yat-sen University Cancer Center; Internal Medicine of Oncology
Guangzhou, , China
Guangdong General Hospital
Guangzhou, , China
Sun Yat-Sen University Cancer Center - Huangpu Campus
Guangzhou, , China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, , China
The Second Affiliated Hospital of Zhejiang University College
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Shandong Cancer Hospital
Jinan, , China
Luoyang Central Hospital
Luoyang, , China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, , China
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
Shanghai, , China
Zhongshan Hospital Fudan University
Shanghai, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee
Shenzhen, , China
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
Shijiazhuang, , China
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Hubei Cancer Hospital
Wuhan, , China
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, , China
Zhejiang Cancer Hospital
Zhejiang, , China
Henan Cancer Hospital
Zhengzhou, , China
Nemocnice Horovice, NH Hospital a.s.; Oncology Department
Hořovice, , Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Prague, , Czechia
Krajska nemocnice T. Bati, a.s.
Zlín, , Czechia
Herlev Hospital; Afdeling for Kræftbehandling
Herlev, , Denmark
Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed
Odense C, , Denmark
Sygehus Lillebælt, Vejle
Vejle, , Denmark
Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy
Ars-Laquenexy, , France
Institut Sainte Catherine
Avignon, , France
CH de Beauvais
Beauvais, , France
CHU Jean Minjoz
Besançon, , France
Clinique Tivoli; Sce Radiotherapie
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Centre Hospitalier Fleyriat
Bourg-en-Bresse, , France
CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie
Brest, , France
CRLCC-Francois Baclesse; Oncologie Médicale
Caen, , France
CH de Cholet; oncologie
Cholet, , France
Centre Hospitalier de Compiegne
Compiègne, , France
Centre Hospitalier Alpes Leman
Contamine-sur-Arve, , France
Centre Georges Francois Leclerc
Dijon, , France
Centre Hospitalier Departemental de Vendee
La Roche-sur-Yon, , France
Clinique Chenieux; Oncology
Limoges, , France
Centre Hospitalier Bretagne Sud
Lorient, , France
Hopital Prive Jean Mermoz
Lyon, , France
Hôpital Saint Joseph
Marseille, , France
Clinique Clémentville
Montpellier, , France
Institut régional du Cancer Montpellier
Montpellier, , France
l'Hôpital privé du Confluent SAS
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
CH Annecy Genevois site Annecy; Oncologie
Pringy, , France
Chi De Cornouaille; Oncologie Hospitalisation
Quimper, , France
Institut Jean Godinot
Reims, , France
Institut du Cancer Coulancy Reims
Reims, , France
Centre Henri Becquerel
Rouen, , France
Institut De Cancerologie Lucien Newrth
Saint-Priest-en-Jarez, , France
Centre Paul Strauss
Strasbourg, , France
Hopitaux Du Leman - Site Georges Pianta
Thonon-les-Bains, , France
Institut Claudius Régaud
Toulouse, , France
CHU Tours - Hôpital Bretonneau
Tours, , France
Hopital Prive Drome Ardeche; Hopital De Jour
Valence, , France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, , France
Studienzentrum Berlin City
Berlin, , Germany
St. Elisabeth-Krankenhaus
Cologne, , Germany
St. Johannes-Hospital
Dortmund, , Germany
Onkozentrum Dres. Göhler
Dresden, , Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, , Germany
Praxis für Hamatologie und Onkologie
Erfurt, , Germany
Onkodok GmbH
Gütersloh, , Germany
Albertinen-Krankenhaus Klinik f.Gynäkologie und Geburtshilfe
Hamburg, , Germany
Ärztehaus am Bahnhofsplatz; Praxis Uleer/Pourfard
Hildesheim, , Germany
ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik
Karlsruhe, , Germany
Klinikum Ludwigsburg; Studiensekretariat
Ludwigsburg, , Germany
St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz
Mainz, , Germany
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz, , Germany
Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller
Mayen, , Germany
Klinikum Memmingen; Abt.Gynäkologie
Memmingen, , Germany
Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin
Minden, , Germany
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
Mönchengladbach, , Germany
Klinikum der Universität München; Frauenklinik - Onkologie II
München, , Germany
Klinikum Neumarkt; Frauenklinik
Neumarkt in der Oberpfalz, , Germany
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
Offenbach, , Germany
Johanniter Frauenklinik Stendal Germany
Stendal, , Germany
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
Stralsund, , Germany
Universitätsklinik Tübingen; Frauenklinik
Tübingen, , Germany
GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe
Weinheim, , Germany
Marien-Hospital Witten, MVZ Witten
Witten, , Germany
Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe
Worms, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
Hong Kong, , Hong Kong
Queen Elizabeth Hospital Department of Clinical Oncology
Kowloon, , Hong Kong
National Institute of Oncology, A Dept of Internal Medicine
Budapest, , Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
Miskolc, , Hungary
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
Pécs, , Hungary
Mater Misecordiae University Hospital
Dublin, , Ireland
Beaumont Hospital; Cancer Clinical Trials Unit
Dublin, , Ireland
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah Med Org Kiryat; Oncology Institute
Jerusalem, , Israel
Meir Medical center, Pediatrics
Kfar Saba, , Israel
Rabin MC; Davidof Center - Oncology Institute
Petah Tikva, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Abruzzo, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi; UO Farmacia Clinica
Bologna, Emilia-Romagna, Italy
U.O Medicina Oncologica Ospedale di Carpi
Carpi, Emilia-Romagna, Italy
Ospedale Degli Infermi - Faenza; Oncologia Medica
Faenza, Emilia-Romagna, Italy
Azienda Ospedaliero - Universitaria di Modena Policlinico
Modena, Emilia-Romagna, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Emilia-Romagna, Italy
Ospedale degli Infermi
Rimini, Emilia-Romagna, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
Udine, Friuli Venezia Giulia, Italy
Policlinico Universitario Campus Biomedico Di Roma
Rome, Lazio, Italy
Azienda Ospedaliero Universitaria San Martino
Genoa, Liguria, Italy
ASST DI LECCO; Oncologia Medica
Lecco, Lombardy, Italy
Ospedale Mater Salutis
Legnago (VR), Lombardy, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, Italy
Fondazione Salvatore Maugeri
Pavia, Lombardy, Italy
Policlinico San Mattea
Pavia, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, Italy
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
Alessandria, Piedmont, Italy
Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica
Ponderano (BI), Piedmont, Italy
Ospedale Santa Maria Annunziata; Oncologia
Bagno a Ripoli, Tuscany, Italy
Azienda Usl 7; Dept. Oncologico
Poggibonsi, Tuscany, Italy
Nuovo Ospedale Di Prato
Prato, Tuscany, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia, Umbria, Italy
Aichi Cancer Center Hospital
Aichi, , Japan
Chiba Cancer Center
Chiba, , Japan
Shikoku Cancer Center
Ehime, , Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, , Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido, , Japan
Hyogo Medical University Hospital
Hyōgo, , Japan
University of Tsukuba Hospital
Ibaraki, , Japan
Sagara Hospital
Kagoshima, , Japan
Kanagawa Cancer Center
Kanagawa, , Japan
Tokai University Hospital
Kanagawa, , Japan
Kyoto University Hospital
Kyoto, , Japan
Fukushima Medical University Hospital
Miyagi, , Japan
Okayama University Hospital
Okayama, , Japan
Naha-nishi Clinic
Okinawa, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Saitama Medical University International Medical Center
Saitama, , Japan
Saitama Cancer Center
Saitama, , Japan
Shizuoka Cancer Center
Shizuoka, , Japan
St. Luke's Internat. Hospital, Breast Surgical Oncology
Tokyo, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Iem-Fucam
D.F., Mexico CITY (federal District), Mexico
Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
Distrito Federal, Mexico CITY (federal District), Mexico
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), Mexico
Centro Médico Zambrano Hellion
Monterrey, Nuevo León, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca, Mexico
Oncologico Potosino
San Luis Potosí City, San Luis Potosí, Mexico
Merida | Investigacion Clinica
Mérida, Yucatán, Mexico
CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO
Mexico City, , Mexico
Centro Medico Dalinde
Mexico City, , Mexico
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
Arequipa, , Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, , Peru
Oncosalud Sac; Oncología
Lima, , Peru
Instytut MSF Sp. z o.o.
?ód?, , Poland
MedPolonia
Poznan, , Poland
Wielkopolskie Centrum Onkologi
Poznan, , Poland
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy; Klinika Onkologii
Warsaw, , Poland
"Filantropia" Clinical Hospital; Gynecological Oncology
Bucharest, , Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala
Cluj-Napoca, , Romania
Centrul de Oncologie Sfantul Nectarie
Craiova, , Romania
Medsi Clinic
Moscow, Adygeya Republic, Russia
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, Arhangelsk, Russia
Bashkirian Republican Clinical Oncology Dispensary
Ufa, Bashkortostan Republic, Russia
Oncologica Dispensary #2
Sochi, Krasnodarskiy Kray, Russia
Evimed
Chelyabinsk, Kurgan Oblast, Russia
Moscow Clinical Scientific Center
Moscow, Moscow Oblast, Russia
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
Moscow, Moscow Oblast, Russia
P.A. Herzen Oncological Inst. ; Oncology
Moscow, Moscow Oblast, Russia
Nizhny Novgorod Regional Clinical Oncology Center
Nizhny Novgorod, Niznij Novgorod, Russia
Mordovia State University
Saransk, Respublika Mordoviya, Russia
National Medical Research Center for Oncology
Rostov-on-Don, Rostov Oblast, Russia
LLC Strategic Medical Systems
Saint Petersburg, Sankt-Peterburg, Russia
EosMed LLC
Saint Petersburg, Sankt-Peterburg, Russia
Private Healthcare Institution Clinical Hospital RZhD Medicine
Saint Petersburg, Sankt-Peterburg, Russia
LCC Center of Palliative Medicine - Devita
Saint Petersburg, Sankt-Peterburg, Russia
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint Petersburg, Sankt-Peterburg, Russia
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
Saint Petersburg, Sankt-Peterburg, Russia
Pyatigorsky Oncologic Dispensary
Pyatigorsk, Stavropol Kray, Russia
Regional Clinical Oncology Hospital
Yaroslavl, Yaroslavl Oblast, Russia
Regional Oncology Hospital
Irkutsk, , Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, , Russia
Regional Oncology Dispensary; Dept of Chemotherapy
Novgorod Veliky, , Russia
BIH at Omsk Region "Clinical Oncology Dispensary", Outpatient clinic
Omsk, , Russia
Multidisciplinary clinic Reaviz
Samara, , Russia
Samara Regional Oncology Dispensary
Samara, , Russia
Regional Clinical Hospital
Saratov, , Russia
SHI Volgograd Regional Clinical Oncological Dispensary#1
Volgograd, , Russia
National University Hospital; Medical Oncology
Singapore, , Singapore
National Cancer Centre
Singapore, , Singapore
Chungbuk National University Hospital
Cheongju-si, , South Korea
Soon Chun Hyang University Cheonan Hospital
Dongnam-gu, Cheonan-si, , South Korea
National Cancer Center
Goyang-si, , South Korea
CHA Bundang Medical Center
Gyeonggi-do, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital; Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul St Mary's Hospital
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Ulsan University Hosiptal
Ulsan, , South Korea
Wonju Christian Hospital
Wŏnju, , South Korea
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona, Barcelona, Spain
Hospital General De Catalunya; Servicio de Oncologia
Sant Cugat del Vallès, Barcelona, Spain
Consorci Hospitalari de Terrassa
Terrassa, Barcelona, Spain
Hospital de Jerez
Jerez de la Frontera, Cadiz, Spain
Hospital Provincial Castellón
Castellon de LA Plana/castello de LA Plana, Castellon, Spain
Centro Oncologico de Galicia COG; Medical Oncology
A Coruña, LA Coruña, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, Spain
Hospital Infanta Sofia; Servico de Oncologia
San Sebastián de los Reyes, Madrid, Spain
Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología
Vigo, Pontevedra, Spain
Hospital Universitari Sant Joan de Reus; Planta baja, color lila
Reus, Tarragona, Spain
Hospital Universitario de Canarias;servicio de Oncologia
San Cristóbal de La Laguna, Tenerife, Spain
Hospital Universitario de Burgos
Burgos, , Spain
Hospital San Pedro De Alcantara; Servicio de Oncologia
Cáceres, , Spain
Complejo Hospitalario de Jaen
Jaén, , Spain
Complejo Asistencial Universitario de Leon; Servicio de Oncologia
León, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, , Spain
Centro Integral Oncológico Clara Campal Ensayos Clínicos START
Madrid, , Spain
Hosp Univ Fundacion Alcorcon
Madrid, , Spain
Hospital Universitario de Fuenlabrada; Servicio de Oncologia
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, , Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia, , Spain
Hospital Quirón Sagrado Corazón
Seville, , Spain
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital General Universitario de Valencia; Servicio de oncologia
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
Zaragoza, , Spain
Hirslanden Medical Center - Tumorzentrum
Aarau, , Switzerland
Centre Hospitalier Universitaire Vaudois - Lausanne
Lausanne, , Switzerland
Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
Zurich, , Switzerland
Chunghua Christian hospital
Changhua, , Taiwan
Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital
Kaoshiung City, , Taiwan
E-Da Cancer Hospital; Hematology- Oncology Department
Kaoshiung, , Taiwan
Chi Mei Medical Center Liou Ying Campus
Liuying Township, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital - Taipei Branch
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation Linkou Branch
Taoyuan, , Taiwan
Rajavithi Hospital; Division of Medical Oncology
Bangkok, , Thailand
Ramathibodi Hospital; Medicine/Oncology
Bangkok, , Thailand
Siriraj Hospital; Clinical Research Center, Pharmacy Department
Bangkok, , Thailand
Songklanagarind Hospital
Hat Yai, , Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, , Thailand
Lampang Cancer Hospital
Lampang, , Thailand
King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University
Patumwan, , Thailand
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
Adana, , Turkey (Türkiye)
Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi
Bursa, , Turkey (Türkiye)
Izmir Ekonomi Universitesi Medical Park Hastanesi
Izmir, , Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi
Mersin, , Turkey (Türkiye)
Medikal Park Samsun
Samsun, , Turkey (Türkiye)
Yulis Medical and Diagnostic Center
Zaporizhzhia, Katerynoslav Governorate, Ukraine
MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department
Dnipro, KIEV Governorate, Ukraine
Municipal Institution Odesa Regional Oncology Dispensary
Odesa, KIEV Governorate, Ukraine
Vinnytsya Regional Clinical Oncology Dispensary
Vinnytsia, Podolia Governorate, Ukraine
Regional Oncology Center; Department of Mammology
Chernihiv, , Ukraine
Chernivtsi Regional Clinical Oncology Dispensary
Chernivtsi, , Ukraine
City Clinical Hospital #4
Dnipropetrovsk, , Ukraine
Municipal Institution Kirovograd Regional Oncology Dispensary
Kirovograd, , Ukraine
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
Kryvyi Rih, , Ukraine
Volyn Regional Oncology Dispensary
Lutsk, , Ukraine
Lviv State Oncological Regional Treatment and Diagnostic Center
Lviv, , Ukraine
Municipal Institution Odesa Regional Clinical Hospital
Odesa, , Ukraine
Sumy Reg. Clin. Oncological Dispensary; Thoracall Department
Sumy, , Ukraine
CCCH City Oncological Center SHEI Uzhgorod NU
Uzhhorod, , Ukraine
Transkarpathian Regional Oncology Clinic; Chemotherapy
Uzhhorod, , Ukraine
Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University
Zaporizhzhya, , Ukraine
NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
Edinburgh, , United Kingdom
Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, , United Kingdom
Leeds Teaching Hosp NHS Trust;St James's Institute of Onc
Leeds, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, , United Kingdom
University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ignatiadis M, Bailey A, McArthur H, El-Abed S, de Azambuja E, Metzger O, Chui SY, Dieterich M, Perretti T, Shearer-Kang E, Molinero L, Steger GG, Jassem J, Lee SC, Higgins M, Zarba J, Schmidt M, Gomez H, Guerrero Zotano A, Moscetti L, Chiu J, Munzone E, Ben-Baruch NE, Bajetta E, Ohno S, Im SA, Werutsky G, Gal-Yam EN, Gonzalez Farre X, Tseng LM, Jacot W, Gluz O, Shao Z, Shparyk Y, Zimina A, Winer E, Cameron DA, Viale G, Saji S, Gelber R, Piccart M. Adjuvant Atezolizumab for Early Triple-Negative Breast Cancer: The ALEXANDRA/IMpassion030 Randomized Clinical Trial. JAMA. 2025 Jan 30;333(13):1150-60. doi: 10.1001/jama.2024.26886. Online ahead of print.
Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-003695-47
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BIG 16-05
Identifier Type: OTHER
Identifier Source: secondary_id
AFT-27
Identifier Type: OTHER
Identifier Source: secondary_id
ALEXANDRA
Identifier Type: OTHER
Identifier Source: secondary_id
WO39391
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.