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

Triple Negative Breast Cancer Clinical Trial

— IMpassion030  

Official title:

A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498716
• Other study ID #: WO39391
• Secondary ID: 2016-003695-47BI
• Status: Completed
• Phase: Phase 3
• Start date: August 2, 2018
• Est. completion date: August 14, 2023

Study information

• Verified date: September 2023
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2203
• Est. completion date: August 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Argentina	Centro de Oncologia e; Investigacion Buenos Aires - COIBA	Berazategui
Argentina	Hospital Britanico de Buenos Aires	Ciudad Autonoma Buenos Aires
Argentina	INSTITUTO DE INVESTIGACIONES METABOLICAS (IDIM); Oncology	Ciudad Autonoma Buenos Aires
Argentina	Clinica Universitaria Reina Fabiola	Cordoba
Argentina	Fundación Ars Medica	Jujuy
Argentina	Centro Oncologico Riojano Integral (CORI)	La Rioja
Argentina	Instituto de Oncología de Rosario	Rosario
Argentina	Centro Medico San Roque	San Miguel de Tucuman
Argentina	Centro de Investigacion Clinica - Clinica Viedma S.A.; Oncology Department	Viedma
Australia	Royal Adelaide Hospital; Cancer Centre	Adelaide	South Australia
Australia	Icon Cancer Care Wesley	Auchenflower	Queensland
Australia	Box Hill Hospital; Eastern Clinical Research Unit	Box Hill	Victoria
Australia	Icon Cancer Foundation; Icon Cancer Care Chermside	Chermside	Queensland
Australia	Monash Medical Centre	Clayton	Victoria
Australia	St Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	Austin Hospital Olivia Newton John Cancer Centre	Heidelberg	Victoria
Australia	Ashford Cancer Center Research	Kurralta Park	South Australia
Australia	Lismore Base Hospital	Lismore	New South Wales
Australia	Macquarie University Hospital	Macquarie Park	New South Wales
Australia	Maroondah Hospital; Breast Clinic	Ringwood East	Victoria
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	Tweed Hospital	Tweed Heads	New South Wales
Australia	Sydney Adventist Hospital	Wahroonga	New South Wales
Australia	Princess Alexandra Hospital; Cancer Trials Unit	Woolloongabba	Queensland
Austria	Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie	Graz
Austria	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	General Hospital Hietzing, KLI; Dept. Obstet&Gynecol	Vienna
Austria	Salzkammergut-Klinikum Voecklabruck	Vöcklabruck
Austria	Klinikum Kreuzschwestern Wels; Iv. Interne Abt.	Wels
Austria	Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie	Wien
Belgium	AZ KLINA	Brasschaat
Belgium	Institut Jules Bordet	Bruxelles
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	CHC MontLégia	Liege
Belgium	Chr de La Citadelle	Liège
Belgium	CHU Ambroise Paré	Mons
Belgium	Clinique Sainte-Elisabeth; Oncologie	Namur
Belgium	Vitaz	Sint Niklaas
Brazil	Hospital de Cancer de Barretos	Barretos	SP
Brazil	Crio - Centro Regional Integrado de Oncologia	Fortaleza	CE
Brazil	Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda	Ijui	RS
Brazil	Clinica de Neoplasias Litoral	Itajai	SC
Brazil	Hospital Amaral Carvalho	Jau	SP
Brazil	Hospital das Clinicas - UFRGS	Porto Alegre	RS
Brazil	Hospital Mae de Deus	Porto Alegre	RS
Brazil	Hospital Moinhos de Vento	Porto Alegre	RS
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Instituto Nacional de Cancer - INCa; Oncologia	Rio de Janeiro	RJ
Brazil	Nucleo de Oncologia da Bahia - NOB	Salvador, Bahia	BA
Brazil	Faculdade de Medicina do ABC - FMABC	Santo Andre	SP
Brazil	Instituto Brasileiro de Controle Do Câncer ? São Camilo Oncologia	Sao Paulo	SP
Brazil	Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira	São Paulo	SP
Brazil	Hospital Jardim Amália	Volta Redonda	RJ
China	Beijing Hospital; Internal Medicine-Oncology	Beijing
China	Beijing Union Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	Jilin Cancer Hospital	Changchun
China	The First Hospital of Jilin University	Changchun City
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 City
China	Guangdong General Hospital	Guangzhou
China	Sun Yat-Sen University Cancer Center - Huangpu Campus	Guangzhou
China	Sun yat-sen University Cancer Center; Internal Medicine of Oncology	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 City
China	Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School	Nanjing City
China	The Affiliated Hospital of Medical College Qingdao University	Qingdao
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 City
China	The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee	Shenzhen City
China	Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)	Shijiazhuang
China	Hubei Cancer Hospital	Wuhan
China	Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology	Wuhan City
China	The First Affiliated Hospital of Xian Jiao Tong University	Xi'an City
China	Zhejiang Cancer Hospital	Zhejiang
China	Henan Cancer Hospital	Zhengzhou
Czechia	Nemocnice Horovice, NH Hospital a.s.; Oncology Department	Horovice
Czechia	Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika	Praha 2
Czechia	Krajska nemocnice T. Bati, a.s.	Zlin
Denmark	Herlev Hospital; Afdeling for Kræftbehandling	Herlev
Denmark	Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed	Odense C
Denmark	Sygehus Lillebælt, Vejle	Vejle
France	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 Cedex
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	Compiegne
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 du Cancer Coulancy Reims	Reims
France	Institut Jean Godinot	Reims
France	Centre Henri Becquerel	Rouen
France	Institut De Cancerologie Lucien Newrth	St Priest en Jarez CEDEX
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	Vandoeuvre-Les-Nancy
France	Institut Gustave Roussy; Departement Oncologie Medicale	Villejuif
Germany	Studienzentrum Berlin City	Berlin
Germany	St. Johannes-Hospital	Dortmund
Germany	BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie	Dresden
Germany	Onkozentrum Dres. Göhler	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	St. Elisabeth-Krankenhaus	Köln
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 i.d.OPf.
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
Hong Kong	Pamela Youde Nethersole Eastern Hospital; Clinical Oncology	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Queen Elizabeth Hospital Department of Clinical Oncology	Kowloon
Hungary	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
Ireland	Beaumont Hospital; Cancer Clinical Trials Unit	Dublin
Ireland	Mater Misecordiae University Hospital	Dublin
Israel	Hadassah Med Org Kiryat; Oncology Institute	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Meir Medical center, Pediatrics	Kfar Sava
Israel	Rabin MC; Davidof Center - Oncology Institute	Petach Tikva
Israel	The Chaim Sheba Medical Center	Ramat Gan
Italy	Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria	Alessandria	Piemonte
Italy	Ospedale Santa Maria Annunziata; Oncologia	Bagno a Ripoli	Toscana
Italy	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 San Martino	Genova	Liguria
Italy	ASST DI LECCO; Oncologia Medica	Lecco	Lombardia
Italy	Ospedale Mater Salutis	Legnago (VR)	Lombardia
Italy	Istituto Europeo Di Oncologia	Milano	Lombardia
Italy	Azienda Ospedaliero - Universitaria di Modena Policlinico	Modena	Emilia-Romagna
Italy	Azienda Ospedaliero Universitaria di Parma	Parma	Emilia-Romagna
Italy	Fondazione Salvatore Maugeri	Pavia	Lombardia
Italy	Policlinico San Mattea	Pavia	Lombardia
Italy	Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia	Perugia	Umbria
Italy	Azienda Usl 7; Dept. Oncologico	Poggibonsi	Toscana
Italy	Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica	Ponderano (BI)	Piemonte
Italy	Nuovo Ospedale Di Prato	Prato	Toscana
Italy	Ospedale degli Infermi	Rimini	Emilia-Romagna
Italy	Policlinico Universitario Campus Biomedico Di Roma	Roma	Lazio
Italy	Istituto Clinico Humanitas	Rozzano (MI)	Lombardia
Italy	A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia	Udine	Friuli-Venezia Giulia
Japan	Aichi Cancer Center Hospital	Aichi
Japan	Chiba Cancer Center	Chiba
Japan	Shikoku Cancer Center	Ehime
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Hiroshima City Hiroshima Citizens Hospital	Hiroshima
Japan	National Hospital Organization Hokkaido Cancer Center	Hokkaido
Japan	Hyogo Medical University Hospital	Hyogo
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	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 Cancer Center	Saitama
Japan	Saitama Medical University International Medical 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
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si
Korea, Republic of	Soon Chun Hyang University Cheonan Hospital	Dongnam-gu, Cheonan-si
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	CHA Bundang Medical Center	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital; Yonsei University Health System	Seoul
Korea, Republic of	Ajou University Hospital	Suwon City
Korea, Republic of	Ulsan University Hosiptal	Ulsan
Korea, Republic of	Wonju Christian Hospital	Wonju
Mexico	Health Pharma Professional Research	Cdmx	Mexico CITY (federal District)
Mexico	Iem-Fucam	D.f.	Mexico CITY (federal District)
Mexico	Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios	Distrito Federal	Mexico CITY (federal District)
Mexico	Merida | Investigacion Clinica	Mérida	Yucatan
Mexico	CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO	Mexico City
Mexico	Centro Medico Dalinde	Mexico City
Mexico	Centro Médico Zambrano Hellion	Monterrey	Nuevo LEON
Mexico	Centro de Investigacion Clinica de Oaxaca	Oaxaca de Juárez	Oaxaca
Mexico	Oncologico Potosino	San Luis Potosí	SAN LUIS Potosi
Peru	Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology	Arequipa
Peru	Instituto Nacional de Enfermedades Neoplasicas	Lima
Peru	Oncosalud Sac; Oncología	Lima
Poland	Instytut MSF Sp. z o.o.	?ód?
Poland	MedPolonia	Poznan
Poland	Wielkopolskie Centrum Onkologi	Poznan
Poland	Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy; Klinika Onkologii	Warszawa
Romania	"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
Russian Federation	Arkhangelsk Regional Clinical Oncology Dispensary	Arkhangelsk	Arhangelsk
Russian Federation	Evimed	Chelyabinsk	Kurgan
Russian Federation	Regional Oncology Hospital	Irkutsk
Russian Federation	Ivanovo Regional Oncology Dispensary	Ivanovo
Russian Federation	FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF	Moscow	Moskovskaja Oblast
Russian Federation	Medsi Clinic	Moscow	Adygeja
Russian Federation	Moscow Clinical Scientific Center	Moscow	Moskovskaja Oblast
Russian Federation	P.A. Herzen Oncological Inst. ; Oncology	Moscow	Moskovskaja Oblast
Russian Federation	Nizhny Novgorod Regional Clinical Oncology Center	Nizhny Novgorod	Niznij Novgorod
Russian Federation	Regional Oncology Dispensary; Dept of Chemotherapy	Novgorod Veliky
Russian Federation	BIH at Omsk Region "Clinical Oncology Dispensary", Outpatient clinic	Omsk
Russian Federation	Pyatigorsky Oncologic Dispensary	Pyatigorsk	Stavropol
Russian Federation	National Medical Research Center for Oncology	Rostov-na-donu	Rostov
Russian Federation	FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"	Saint-Petersburg	Sankt Petersburg
Russian Federation	S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)	Saint-Petersburg	Sankt Petersburg
Russian Federation	Multidisciplinary clinic Reaviz	Samara
Russian Federation	Samara Regional Oncology Dispensary	Samara
Russian Federation	EosMed LLC	Sankt-peterburg	Sankt Petersburg
Russian Federation	LCC Center of Palliative Medicine - Devita	Sankt-peterburg	Sankt Petersburg
Russian Federation	LLC Strategic Medical Systems	Sankt-peterburg	Sankt Petersburg
Russian Federation	Mordovia State University	Saransk	Mordovija
Russian Federation	Regional Clinical Hospital	Saratov
Russian Federation	Oncologica Dispensary #2	Sochi	Krasnodar
Russian Federation	Private Healthcare Institution Clinical Hospital RZhD Medicine	St. Petersburg	Sankt Petersburg
Russian Federation	Bashkirian Republican Clinical Oncology Dispensary	UFA	Baskortostan
Russian Federation	SHI Volgograd Regional Clinical Oncological Dispensary#1	Volgograd
Russian Federation	Regional Clinical Oncology Hospital	Yaroslavl	Jaroslavl
Singapore	National Cancer Centre	Singapore
Singapore	National University Hospital; Medical Oncology	Singapore
Spain	Centro Oncologico de Galicia COG; Medical Oncology	A Coruna	LA Coruña
Spain	Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia	Badalona	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital San Pedro De Alcantara; Servicio de Oncologia	Caceres
Spain	Hospital Provincial Castellón	Castellon DE LA Plana/castello DE LA Plana	Castellon
Spain	Complejo Hospitalario de Jaen	Jaen
Spain	Hospital de Jerez	Jerez De La Frontera	Cadiz
Spain	Hospital Universitario de Canarias;servicio de Oncologia	La Laguna	Tenerife
Spain	Complejo Asistencial Universitario de Leon; Servicio de Oncologia	Leon
Spain	Centro Integral Oncológico Clara Campal Ensayos Clínicos START	Madrid
Spain	Hosp Univ Fundacion Alcorcon	Madrid
Spain	Hospital General Universitario Gregorio Marañon; Servicio de Oncologia	Madrid
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid
Spain	Hospital Universitario de Fuenlabrada; Servicio de Oncologia	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda	Madrid
Spain	Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia	Malaga
Spain	Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia	Murcia
Spain	Hospital Son Llatzer	Palma de Mallorca	Islas Baleares
Spain	Hospital Universitari Sant Joan de Reus; Planta baja, color lila	Reus	Tarragona
Spain	Hospital Infanta Sofia; Servico de Oncologia	San Sebastian de Los Reyes	Madrid
Spain	Hospital General De Catalunya; Servicio de Oncologia	Sant Cugat Del Valles	Barcelona
Spain	Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia	Santiago de Compostela	LA Coruña
Spain	Hospital Quirón Sagrado Corazón	Sevilla
Spain	Consorci Hospitalari de Terrassa	Terrassa	Barcelona
Spain	Hospital Mutua de Terrassa; Servicio de Oncologia	Terrassa	Barcelona
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital General Universitario de Valencia; Servicio de oncologia	Valencia
Spain	Instituto Valenciano Oncologia; Oncologia Medica	Valencia
Spain	Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología	Vigo	Pontevedra
Spain	Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia	Zaragoza
Switzerland	Hirslanden Medical Center - Tumorzentrum	Aarau
Switzerland	Centre Hospitalier Universitaire Vaudois - Lausanne	Lausanne
Switzerland	Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich	Zürich
Taiwan	Chunghua Christian hospital	Changhua
Taiwan	E-Da Cancer Hospital; Hematology- Oncology Department	Kaoshiung
Taiwan	Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital	Kaoshiung City
Taiwan	Chi Mei Medical Center Liou Ying Campus	Liuying Township
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Mackay Memorial Hospital - Taipei Branch	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei City
Taiwan	Chang Gung Medical Foundation Linkou Branch	Taoyuan City
Thailand	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	Muang Lampang
Thailand	King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University	Patumwan
Turkey	Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi	Adana
Turkey	Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi	Bursa
Turkey	Ege Universitesi Hastanesi (Saglik Uygulama ve Arastirma Merkezi)	Izmir
Turkey	Izmir Ekonomi Universitesi Medical Park Hastanesi	Izmir
Turkey	Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi	Mersin
Turkey	Medikal Park Samsun	Samsun
Ukraine	Regional Oncology Center; Department of Mammology	Chernigiv
Ukraine	Chernivtsi Regional Clinical Oncology Dispensary	Chernivtsi
Ukraine	MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department	Dnipro	KIEV Governorate
Ukraine	City Clinical Hospital #4	Dnipropetrovsk
Ukraine	Municipal Noncommercial Institution Regional Center of Oncology	Kharkiv	Kharkiv Governorate
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	Municipal Institution Odesa Regional Oncology Dispensary	Odesa	KIEV Governorate
Ukraine	Sumy Reg. Clin. Oncological Dispensary; Thoracall Department	Sumy
Ukraine	CCCH City Oncological Center SHEI Uzhgorod NU	Uzhgorod
Ukraine	Transkarpathian Regional Oncology Clinic; Chemotherapy	Uzhgorod
Ukraine	Vinnytsya Regional Clinical Oncology Dispensary	Vinnytsya	Podolia Governorate
Ukraine	Yulis Medical and Diagnostic Center	Zaporizhzhia	Katerynoslav Governorate
Ukraine	Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University	Zaporizhzhya
United Kingdom	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	Guys and St Thomas NHS Foundation Trust, Guys Hospital	London
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 States	University of Maryland Greenebaum Comprehensive Cancer Center	Baltimore	Maryland
United States	Advocate Illinois Masonic Outpatient Center for Advanced Care	Chicago	Illinois
United States	John Muir Health Clinical Research Center	Concord	California
United States	Des Moines Oncology Research Association	Des Moines	Iowa
United States	Fairview Southdale Medical Oncology Clinic	Edina	Minnesota
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	Baptist - MD Anderson Cancer Center	Jacksonville	Florida
United States	HCA Midwest Division	Kansas City	Missouri
United States	Monter Cancer Center	Lake Success	New York
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	New Hampshire Hematology Oncology	Manchester	New Hampshire
United States	SCRI	Nashville	Tennessee
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	Intermountain Precision Genomics Cancer Research Clinic-Dixie	Saint George	Utah
United States	Martin-O?Neil Cancer Center	Saint Helena	California
United States	Cancer Center of Kansas	Wichita	Kansas

Sponsors (5)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Alliance Foundation Trials (AFT), Breast International Group, Frontier Science & Technology Research Foundation, Inc., Institut Jules Bordet/Clinical Trials Support Unit (IJB/CTSU)

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  China,  Czechia,  Denmark,  France,  Germany,  Hong Kong,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Peru,  Poland,  Romania,  Russian Federation,  Singapore,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive Disease-Free Survival (iDFS)	iDFS events are defined as follows: Ipsilateral invasive breast tumor recurrence; Ipsilateral local-regional invasive breast cancer recurrence; Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence; Death attributable to any cause	Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years).
Secondary	Overall Survival (OS)		Randomization to death from any cause through the end of study (approximately 7 years)
Secondary	Disease-Free Survival (DFS)	DFS is defined as any event of the primary endpoint and new diagnosis of an ipsilateral or contralateral non-invasive breast cancer.	Randomization until the first occurrence of an DFS event, through the end of study (approximately 7 years)
Secondary	Recurrence-Free Interval (RFI)		Randomization until local, regional, or distant disease recurrence of breast cancer, through the end of study (approximately 7 years)
Secondary	Distant RFI		Randomization until distant disease recurrence, through the end of study (approximately 7 years)
Secondary	Percentage of participants with adverse events	Safety Objective	Baseline to end of study (approximately 7 years)
Secondary	Serum concentration of Atezolizumab		Pre-infusion (0 hour), 30 minutes post-infusion on Week 1 Day 1 (infusion length = 60 minutes); pre-infusion on Day 1 of Weeks 5, 9, 13, 21, 33 and 45; at treatment discontinuation (up to approximately 1 year), 120 days after last dose
Secondary	Invasive Disease-Free Survival (iDFS) in PDL1- Selected Patients		Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years)
Secondary	Invasive Disease-Free Survival (iDFS) in Node- Positive Disease		Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years)
Secondary	Invasive Disease Free Survival (iDFS) including second primary non-breast invasive cancer		Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years)
Secondary	Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab		Updated: Pre-infusion (0 hour) on Day 1 of Weeks 1, 5, 9, 13, 21, 33 and 45; at treatment discontinuation (up to Week 51), 120 days after last dose
Secondary	Mean changes from baseline in patient-reported function (role, physical)	Mean changes from baseline score in role, physical function will be assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - Core 30 (EORTC QLQ-C30)	Baseline, Cycle 4 Day 1, Day 1 of every other cycle until Cycle 16 (cycle = 21 days), at the end of treatment/discontinuation visit ((up to approximately 1 year), and during Study Follow-up (up to approximately 7 years).
Secondary	Mean changes from baseline in patient-reported health-related quality of life (HRQoL)	Mean changes from baseline score in HRQoL will be assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - Core 30 (EORTC QLQ-C30).	Time Frame: Baseline, Cycle 4 Day 1, Day 1 of every other cycle until Cycle 16 (cycle = 21 days), at the end of treatment/discontinuation visit (up to approximately 1 year), and during Study Follow-up (up to approximately 7 years).