A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

Breast Cancer Clinical Trial

— Astefania  

Official title:

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04873362
• Other study ID #: WO42633
• Secondary ID: 2020-003681-4020
• Status: Recruiting
• Phase: Phase 3
• Start date: May 4, 2021
• Est. completion date: October 2, 2034

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: WO42633 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. and Canada)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. As of June 4, 2024, this study is no longer accepting any newly screened participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1150
• Est. completion date: October 2, 2034
• Est. primary completion date: August 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed invasive breast carcinoma
• Centrally-confirmed human epidermal growth factor receptor 2 (HER2)-positive invasive breast cancer
• Centrally confirmed PD-L1 and hormone receptor status
• Clinical stage at disease presentation (prior to neoadjuvant therapy): cT4/anyN/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (participants with cT1mi/T1a/T1b/N0 are not eligible)
• Completion of pre-operative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (anthracycline and/or additional HER2-targeted agents are permitted)
• <=12 weeks between primary surgery and randomization
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• Screening left ventricular ejection fraction (LVEF) >= 50% and no decrease in LVEF by >15% from the pre-chemotherapy LVEF. If no pre-chemotherapy LVEF, screening LVEF >= 55%
• Life expectancy >= 6 months
• Adequate hematologic and end organ function

Exclusion Criteria:

• Stage IV breast cancer
• An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy
• Prior treatment with T-DM1, or atezolizumab, or other immune checkpoint inhibitors
• History of exposure to various cumulative doses of anthracyclines
• History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or ductal carcinoma in situ (DCIS)
• Current grade >=2 peripheral neuropathy
• History of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis
• History of or active autoimmune disease or immune deficiency
• Treatment with immunostimulatory or immunosuppressive agents
• Cardiopulmonary dysfunction
• Any known active liver disease

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Recurrence

Intervention

Drug:
• Atezolizumab
Atezolizumab will be administered at a dose of 1200 mg every three weeks (Q3W) for 14 cycles.
• Trastuzumab Emtansine
Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.
• Placebo
Placebo matched to atezolizumab will be administered at a dose of 1200 mg Q3W for 14 cycles.
• Trastuzumab
Trastuzumab will be used to complete 14 cycles of study treatment if trastuzumab emtansine is discontinued for toxicity not considered to be related to the trastuzumab component of the drug.

Locations

Country	Name	City	State
Argentina	Inst. de Oncologia Angel H. Roffo ; Oncology Dept	Buenos aires
Argentina	Centro Oncologico Korben	Caba
Australia	Macarthur Cancer Therapy Centre	Campbelltown	New South Wales
Australia	Kinghorn Cancer Centre; St Vincents Hospital	Darlinghurst	New South Wales
Australia	Peter MacCallum Cancer Centre; Medical Oncology	Melbourne	Victoria
Australia	Royal North Shore Hospital; Department of Medical Oncology	St Leonards	New South Wales
Australia	Princess Alexandra Hospital; Cancer Trials Unit	Woolloongabba	Queensland
Austria	Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie	Innsbruck
Austria	Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie	Linz
Austria	Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.	Salzburg
Austria	AKH - Medizinische Universität Wien; Department of Oncology	Vienna
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	Jessa Zkh (Campus Virga Jesse)	Hasselt
Belgium	Clinique St. Elizabeth	Namur
Brazil	Crio - Centro Regional Integrado de Oncologia	Fortaleza	CE
Brazil	Hospital Araujo Jorge; Departamento de Ginecologia E Mama	Goiania	GO
Brazil	Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda	Ijui	RS
Brazil	Hospital Nossa Senhora da Conceicao	Porto Alegre	RS
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Santa Casa de Misericordia de Porto Alegre	Porto Alegre	RS
Brazil	Hospital Sao Rafael - HSR	Salvador	BA
Brazil	Hospital de Base de Sao Jose do Rio Preto	Sao Jose do Rio Preto	SP
Brazil	Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda	Sao Paulo	SP
Brazil	Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA	Sao Paulo	SP
Bulgaria	COC Plovdiv; First Medical Oncology Department	Plovdiv
Bulgaria	Medical Center "Nadezhda Clinical" EOOD; Medical Oncology Department	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD	Sofia
China	Sichuan Cancer Hospital	Chengdu City
China	West China Hospital - Sichuan University	Chengdu City
China	Chongqing Cancer Hospital	Chongqing
China	Sun Yat-sen Memorial Hospital	Guangzhou
China	Guangdong Provincial People's Hospital; Breast	Guangzhou City
China	The First Affilicated Hospital, Sun Yat-sen University	Guangzhou City
China	Harbin Medical University Cancer Hospital	Harbin
China	The Affiliated Hospital of Medical College Qingdao University	Qingdao
China	Zhongshan Hospital Fudan University	Shanghai
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan City
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an
China	Zhejiang Cancer Hospital	Zhejiang
China	Henan Cancer Hospital	Zhengzhou
Czechia	Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e	Brno
Czechia	Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology	Hradec Kralove
Czechia	Nemocnice AGEL Novy Jicin a.s.; Oddeleni radioterapie a onkologie	Novy Jicin
Czechia	Fakultni nemocnice Olomouc; Onkologicka klinika	Olomouc
Czechia	Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika	Praha 2
Czechia	Fakultni Thomayerova nemocnice; Onkologicka klinika 1. LF UK a FTN	Praha 4 - Krc
Czechia	Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol	Praha 5
Denmark	Herlev Hospital; Afdeling for Kræftbehandling	Herlev
Denmark	Vejle Sygehus; Onkologisk Afdeling	Vejle
Dominican Republic	Oncología & Especialidad, S.R.L	Santiago de Los Caballeros
Dominican Republic	CEMDOE (Centro Médico de Diabetes, Obesidad y Especialidades)	Santo Domingo
Dominican Republic	Centro Integral de Hemato Oncología - CEDIMAT	Santo Domingo
Dominican Republic	Instituto de Oncologia Dr. Heriberto Pieter	Santo Domingo
France	Institut Sainte Catherine	Avignon
France	CHRU Besançon	Besançon
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	Hopital Morvan	Brest
France	Centre Francois Baclesse; Comite Sein	Caen
France	Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie	Creil Cedex 1
France	CLCC Leon Berard Lyon	Lyon
France	Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie	Nimes
France	Groupe Hospitalier Diaconesses	Paris
France	Institut Curie; Oncologie Medicale	Paris
France	Pole Regional De Cancerologie	Poitiers
France	HOPITAL RENE HUGUENIN, Institut Curie; Service d'Oncologie Médicale.	Saint-Cloud
Germany	Klinikum Augsburg; Frauenklinik	Augsburg
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie Dr. Reichert/Dr.Janssen	Aurich
Germany	Hochtaunus-Kliniken gGmbH; Krankenhaus Bad Homburg; Frauenklinik	Bad Homburg vdH
Germany	Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie	Bad Nauheim
Germany	Onkologische Schwerpunktpraxis Kurfürstendamm	Berlin
Germany	Vivantes Klinikum Am Urban; Zentrum für Brusterkrankungen	Berlin
Germany	Gynäkologisches Zentrum Bonn	Bonn
Germany	Marienhospital Bottrop	Bottrop
Germany	Städtisches Klinikum Dessau	Dessau-Roßlau
Germany	Gynonco Düsseldorf, MVZ Medical Center GmbH	Düsseldorf
Germany	Frauenarztpraxis Dr. Apel, Dr. Kolpin	Erfurt
Germany	Universitätsklinikum Erlangen; Frauenklinik	Erlangen
Germany	Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum	Essen
Germany	AGAPLESION Markus-Krankenhaus	Frankfurt
Germany	Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe	Frankfurt
Germany	Praxis für Interdisziplinäre Onkologie und Hämatologie GbR	Freiburg
Germany	St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik	Hamm
Germany	Diakovere Henriettenstift, Frauenklinik	Hannover
Germany	Städtisches Klinikum Karlsruhe gGmbH; Frauenklinik	Karlsruhe
Germany	UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe	Kiel
Germany	Universitätsklinikum Leipzig; Klinik und Poliklinik für Frauenheilkunde	Leipzig
Germany	Städtische Klinik Lüneburg; Frauenklinik	Lüneburg
Germany	Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt	München
Germany	Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe	Offenbach
Germany	Klinikum Ernst von Bergmann; Frauenklinik	Potsdam
Germany	Klinikum am Steinenberg Frauenklinik	Reutlingen
Germany	Leopoldina Krankenhaus der Stadt Schweinfurt GmbH	Schweinfurt
Germany	Johanniter-Krankenhaus Genthin-Stendal; Klinik Für Frauenheilkunde & Geburtshilfe	Stendal
Greece	Alexandras General Hospital of Athens; Oncology Department	Athens
Greece	Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine	Athens
Greece	Metropolitan General Hospital	Cholargos
Greece	University General Hospital of Heraklion	Crete
Greece	University Hospital of Larissa;Department of Medical Oncology	Larissa
Greece	Metropolitan Hospital; 2Nd Oncology Clinic	Piraeus
Greece	Euromedical General Clinic of Thessaloniki; Oncology Department	Thessaloniki
Hong Kong	Pamela Youde Nethersole Eastern Hospital; Clinical Oncology	Hong Kong
Hong Kong	Queen Mary Hospital; Surgery	Hong Kong
Hong Kong	Tuen Mun Hospital; Clinical Oncology	Hong Kong
Hungary	Budapesti Szent Margit Korhaz; Onkologia Osztaly	Budapest
Hungary	Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Podmaniczky utcai telephely	Budapest
Hungary	Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont ; Department of Oncology	Debrecen
Hungary	Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly	Miskolc
India	Hemato Oncology Clinic Ahmedabad Pvt Ltd	Ahmadabad	Gujarat
India	Manipal Hospital; Department of Oncology	Bangalore	Karnataka
India	TATA Medical Centre; Medical Oncology	Kolkata	WEST Bengal
India	Tata Memorial Hospital; Dept of Medical Oncology	Mumbai	Maharashtra
India	HCG Manavata Cancer Centre	Nashik	Maharashtra
India	Rajiv Gandhi Cancer Institute & Research Center	New Delhi	Delhi
India	Max Super Speciality Hospital; Medical Oncology	North WEST Delhi	Delhi
India	Sahyadri Super Specialty Hospital Hadapsar	Pune	Maharashtra
India	Christian Med Clg & Hspt	Ratnagiri Kilminnal	Tamil NADU
Italy	AORN'S.G.Moscati; Oncologia	Avellino	Campania
Italy	Irccs Centro Di Riferimento Oncologico (CRO)	Aviano	Friuli-Venezia Giulia
Italy	Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii	Bologna	Emilia-Romagna
Italy	ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica	Brescia	Lombardia
Italy	Ospedale Civile - Livorno	Livorno	Toscana
Italy	Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1	Milano	Lombardia
Italy	Ospedale San Raffaele; Medical Oncology	Milano	Lombardia
Italy	A.O. Universitaria Policlinico Di Modena; Oncologia	Modena	Emilia-Romagna
Italy	U.O.C. Oncologia Medica Senologica	Napoli	Campania
Italy	Università degli Studi Federico II; Clinica di Oncologia Medica	Napoli	Campania
Italy	University of Eastern Piedmont - Maggiore della Carità University Hospital	Novara	Umbria
Italy	IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda	Padova	Veneto
Italy	Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2	Pisa	Toscana
Italy	Policlinico Universitario Agostino Gemelli	Roma	Lazio
Italy	ASU FC S. M. DELLA MISERICORDIA; Oncologia	Udine	Friuli-Venezia Giulia
Kenya	International Cancer Institute (ICI)	Eldoret
Kenya	Aga Khan University Hospital	Nairobi
Korea, Republic of	Kyungpook National University Medical Center	Daegu
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro 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
Mexico	Centro Medico Dalinde	Cdmx	Mexico CITY (federal District)
Mexico	Health Pharma Professional Research	Cdmx	Mexico CITY (federal District)
Mexico	Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios	Distrito Federal	Mexico CITY (federal District)
Mexico	Investigacion Oncofarmaceutica	La Paz	BAJA California SUR
Mexico	Filios Alta Medicina	Monterrey	Nuevo LEON
Mexico	Centro de Investigacion Clinica de Oaxaca	Oaxaca de Juárez	Oaxaca
New Zealand	Auckland City Hospital, Cancer and Blood Research	Auckland
New Zealand	Tauranga Hospital, Clinical Trials Unit; BOP Clinical School	Tauranga
Poland	Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej	Bialystok
Poland	Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii	Gdansk
Poland	Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi	Gliwice
Poland	Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii	Kraków
Poland	Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii	Poznan
Poland	Centrum Onkologii Instytut im.M. Sklodowskiej-Curie; Klin. Nowot. Piersii i Chirurgii Rekonstruk	Warszawa
Portugal	Hospital CUF Tejo; Oncologia Médica e Hematologia	Lisboa
Portugal	Hospital de Santa Maria; Servico de Oncologia Medica	Lisboa
Portugal	Hospital Beatriz Angelo; Departamento de Oncologia	Loures
Portugal	Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia	Porto
Portugal	IPO do Porto; Servico de Oncologia Medica	Porto
Romania	Filantropia Clinical Hospital; Medical oncology	Bucuresti
Romania	Prof.dr. Alexandru Trestioreanu, The Oncology Institute; Medical oncology I	Bucuresti
Romania	Amethyst Cluj; Medical Oncology	Cluj County
Romania	Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology	Cluj-Napoca
Romania	Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Radioterapie I - Oncologie	Cluj-Napoca
Romania	Centrul de Oncologie Sfantul Nectarie	Craiova
Romania	Oncomed SRL	Timisoara
Russian Federation	SBIH Kaluga Region Clinical Oncology Dispensary	Kaluga
Russian Federation	Republican Clinical Oncological Dispensary of the Ministry of Healthcare; Chemotherapy department	Kazan	Karelija
Russian Federation	Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy	Krasnoyarsk	Krasnodar
Russian Federation	FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF	Moscow	Moskovskaja Oblast
Russian Federation	MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy	Moscow	Moskovskaja Oblast
Russian Federation	Oncology Dispensary#1; Out-Patient Oncology Dept	Moscow	Moskovskaja Oblast
Russian Federation	SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"	Moskva	Moskovskaja Oblast
Russian Federation	Nizhny Novgorod Regional Clinical Oncology Center	Nizhny Novgorod	Niznij Novgorod
Russian Federation	LLC Medical and Sanitary Unit "Clinician"	Novosibirsk
Russian Federation	S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)	Saint-Petersburg	Sankt Petersburg
Russian Federation	SBI of Healthcare Samara Regional Clinical Oncology Dispensary	Samara
Russian Federation	Medical Clinic "AB Medical group"	Sankt-peterburg	Sankt Petersburg
Russian Federation	SBI of Healthcare Leningrad Regional Oncology Dispensary	St PETERBURG	Sankt Petersburg
Russian Federation	FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF	St Petersburg	Sankt Petersburg
Russian Federation	Regional Oncology Dispensary	Tomsk
Russian Federation	Regional Clinical Oncology Hospital	Yaroslavl
Singapore	National Cancer Centre; Medical Oncology	Singapore
South Africa	Mary Potter Oncology Centre	Pretoria
South Africa	Nelson Mandela Academic Clinical Research Unit (NeMACRU)	Umtata
Spain	Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia	A Coruña	LA Coruña
Spain	Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia	Badalona	Barcelona
Spain	Hospital Clinic Barcelona; Servicio de oncologia	Barcelona
Spain	Hospital del Mar; Servicio de Oncologia	Barcelona
Spain	Vall d?Hebron Institute of Oncology (VHIO), Barcelona	Barcelona
Spain	Hospital de Basurto; Servicio de Oncologia	Bilbao	Vizcaya
Spain	Hospital General Universitario de Elche; Servicio de Oncologia	Elche	Alicante
Spain	Hospital Universitario Clínico San Cecilio; Servicio de oncologia	Granada
Spain	Hospital Juan Ramon Jimenez;Servicio de Oncologia	Huelva
Spain	Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia	Jaen
Spain	Hospital de Jerez de la Frontera; Servicio de Oncologia	Jerez de La Frontera	Cadiz
Spain	Hospital Universitario de Canarias;servicio de Oncologia	La Laguna	Tenerife
Spain	Hospital Clinico San Carlos; Servicio de Oncologia	Madrid
Spain	Hospital General Universitario Gregorio Marañon; Servicio de Oncologia	Madrid
Spain	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid
Spain	Hospital Universitario La Paz; Servicio de Oncologia	Madrid
Spain	Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia	Malaga
Spain	Hospital Quiron de Madrid; Servicio de Oncologia	Pozuelo de Alarcon	Madrid
Spain	Corporacio Sanitaria Parc Tauli; Servicio de Oncologia	Sabadell	Barcelona
Spain	Hospital Clinico Universitario de Salamanca; Servicio de Oncologia	Salamanca
Spain	Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia	Santiago de Compostela	LA Coruña
Spain	Hospital Universitario Virgen del Rocio; Servicio de Oncologia	Sevilla
Spain	Hospital Universitario Virgen Macarena; Servicio de Oncologia	Sevilla
Spain	Hospital Clínico Universitario de Valencia; Servicio de Oncología	Valencia
Spain	Hospital Universitario Dr. Peset; Servicio de Oncologia	Valencia
Spain	Hospital Alvaro Cunqueiro; Servicio de Oncologia	Vigo	Pontevedra
Spain	Hospital Universitario Miguel Servet; Servicio Oncologia	Zaragoza
Taiwan	Chia-Yi Christian Hospital; Division of Hemato-oncology	Chia-Yi
Taiwan	China Medical University Hospital; Surgery	Taichung
Taiwan	National Cheng Kung Uni Hospital; Dept of Hematology and Oncology	Tainan
Taiwan	Mackay Memorial Hospital; Dept of Surgery	Taipei
Taiwan	Taipei Veterans General Hospital; Department of Clinical Trial Pharmacy	Taipei
Taiwan	National Taiwan University Hospital ; Dept of Surgery & Hepatitis Research Center	Taipei 100
Thailand	Chulalongkorn Hospital; Medical Oncology	Bangkok
Thailand	Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc	Bangkok
Thailand	Srinagarind Hospital; Department of Surgery	Khon Kaen
Thailand	Songklanagarind Hospital; Department of Surgery	Songkla
Turkey	Adana Baskent University Hospital; Medical Oncology	Adana
Turkey	Ankara Bilkent City Hospital	Ankara
Turkey	Gazi University Medical Faculty, Oncology Hospital	Ankara
Turkey	Hacettepe University Medical Faculty	Ankara
Turkey	Memorial Ankara Hastanesi	Ankara
Turkey	Antalya Training and Research Hospital ; Oncology Department	Antalya
Turkey	Ege University Medical Faculty; Medical Oncology Department	Bornova, ?zm?r
Turkey	Dicle University Faculty of Medicine	Diyarbakir
Turkey	Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi	Edirne
Turkey	Istanbul Faculty of Medicine	Istanbul
Turkey	Istanbul University Cerrahpasa Faculty of Medicine	Istanbul
Turkey	Katip Celebi University Ataturk Training and Research Hospital; Oncology	Izmir
Turkey	Medeniyet University Goztepe Training and Research Hospital.	Kadiköy
Turkey	Inonu University Medical Faculty of Medicine; Medical Oncology Department	Malatya
Turkey	Medical Park Seyhan Hospital; Oncology Department	Seyhan
Turkey	Ac?badem Altunizade Hastanesi; Oncology	Üsküdar
Uganda	Uganda Cancer Institute	Kampala
Ukraine	MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department	Dnipro	KIEV Governorate
Ukraine	CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR	Dnipropetrovsk
Ukraine	Municipal Noncommercial Institution Regional Center of Oncology	Kharkiv	Kharkiv Governorate
Ukraine	Municipal Institution Kirovograd Regional Oncology Dispensary	Kirovograd
Ukraine	Kyiv City Clinical Oncological Center	Kyiv
Ukraine	Innovacia Cancer Center	Liutizh	KIEV Governorate
Ukraine	Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp	Sumy	Kholm Governorate
Ukraine	Uzhgorod Central City Clinical Hospital	Uzhhorod	Katerynoslav Governorate
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Blackpool Victoria Hospital	Blackpool
United Kingdom	Bradford Royal Infirmary; Oncology Department	Bradford
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Velindre Cancer Centre; Clinical Trials Unit	Cardiff
United Kingdom	Cheltenham General Hospital	Cheltenham
United Kingdom	Royal Cornwall Hospital; Dept of Clinical Oncology	Cornwall
United Kingdom	Hairmyres Hospital	East Kilbride
United Kingdom	Raigmore Hospital	Inverness
United Kingdom	Barts & London School of Med; Medical Oncology	London
United Kingdom	Royal Free Hospital	London
United Kingdom	Royal Marsden Hospital - London	London
United Kingdom	University College London Hospital	London
United Kingdom	Christie Hospital NHS Trust	Manchester
United Kingdom	Mount Vernon Cancer Centre	Northwood
United Kingdom	Nottingham City Hospital	Nottingham
United Kingdom	Royal Preston Hospital	Preston
United Kingdom	Glan Clywd Hospital	Rhyl
United Kingdom	Musgrove Park Hospital	Somerset
United Kingdom	Royal Marsden Hospital - Surrey	Surrey
United Kingdom	Walsall Manor Hospital	Walsall
United States	Alabama Oncology	Alabaster	Alabama
United States	Messino Cancer Centers	Asheville	North Carolina
United States	University Cancer & Blood Center, LLC; Research	Athens	Georgia
United States	Greater Baltimore Med Ctr; Dept Berman Cancer Institute	Baltimore	Maryland
United States	Mercy Medical Center	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Central Care Cancer Center; NC	Bolivar	Missouri
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center	Burbank	California
United States	MD Anderson Cancer Center at Cooper	Camden	New Jersey
United States	Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital	Carrollton	Georgia
United States	Innovation Clinical Research Institute	Cerritos	California
United States	Roper St. Francis Healthcare	Charleston	South Carolina
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Sarah Cannon Research Institute / Tennessee Oncology	Chattanooga	Tennessee
United States	Pontchartrain Cancer Center	Covington	Louisiana
United States	Henry Ford Health System; Clinical Trials Office; Clinical Trials Office	Detroit	Michigan
United States	Elmhurst Memorial Healthcare	Elmhurst	Illinois
United States	Providence Regional Cancer Partnership	Everett	Washington
United States	Hematology Oncology Associates of Fredericksburg, Inc.	Fredericksburg	Virginia
United States	California Cancer Associate for Research & Excellence	Fresno	California
United States	The West Clinic; West Cancer Center	Germantown	Tennessee
United States	Glendale Adventist Medical Ctr	Glendale	California
United States	University of Iowa	Iowa City	Iowa
United States	Jackson Oncology Associates, PLLC	Jackson	Mississippi
United States	Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)	Jacksonville	Florida
United States	Kadlec Clinic Hematology and Oncology	Kennewick	Washington
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Joe Arrington Cancer Research & Treatment Center	Lubbock	Texas
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Edward Cancer Center Naperville	Naperville	Illinois
United States	SCRI Oncology Partners	Nashville	Tennessee
United States	Jersey Shore University Medical Centre	Neptune	New Jersey
United States	Virginia Oncology Associates - New Port News	Newport News	Virginia
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	The Valley Hospital	Paramus	New Jersey
United States	Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit	Philadelphia	Pennsylvania
United States	Edward Cancer Center Plainfield	Plainfield	Illinois
United States	Providence Health & Services - Oregon	Portland	Oregon
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Mays Cancer Center at UT Health San Antonio MD Anderson Cancer	San Antonio	Texas
United States	UCLA Medical Center	Santa Monica	California
United States	New England Cancer Specialists	Scarborough	Maine
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Northwest Medical Specialties	Tacoma	Washington
United States	Virginia Oncology Associates - Virginia Beach	Virginia Beach	Virginia
United States	Florida Cancer Specialists	West Palm Beach	Florida
United States	Great Lakes Cancer Center	Williamsville	New York
United States	Lankenau Hospital	Wynnewood	Pennsylvania
Vietnam	K hospital	Hanoi
Vietnam	University of Medicine Center, Ho Chi Minh City	Ho Chi Minh City
Vietnam	Cho Ray Hospital	Hochiminh city
Vietnam	Hochiminh city oncology hospital	Hochiminh city

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  China,  Czechia,  Denmark,  Dominican Republic,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Italy,  Kenya,  Korea, Republic of,  Mexico,  New Zealand,  Poland,  Portugal,  Romania,  Russian Federation,  Singapore,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  Uganda,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive Disease-free Survival (IDFS) in the Full Analysis Set (FAS)	IDFS event is defined as the time from randomization to the first occurrence of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, contralateral invasive breast cancer, distant recurrence, death from any cause.	From baseline until the first occurrence of iDFS event or death, through primary analysis data cut off (approximately 7 years)
Secondary	IDFS Including Second Primary Non-breast Invasive Cancer		From baseline until the first occurrence of iDFS event or death, through the end of study (approximately 10 years from last participant in [LPI])
Secondary	IDFS in the PD-L1-positive and the PD-L1-negative Population	Defined as all randomized participants from the ITT population with a centrally assessed PD-L1-positive [i.e., PD-L1 status of IC1/2/3] or PD-L1-negative status [i.e.,PD-L1 status of IC0] at randomization as per corresponding stratification factors recorded in the interactive web-based response system (IWRS).	From baseline until the first occurrence of iDFS event or death, through the end of study (approximately 10 years from LPI)
Secondary	Disease-free Survival (DFS)		From baseline until the first occurrence of DFS event or death, through the end of study (approximately 10 years from LPI)
Secondary	Overall Survival (OS)		From baseline to death from any cause through the end of study (approximately 10 years from LPI)
Secondary	Distant Recurrence-free Interval (DRFI)		From baseline until distant disease recurrence, through the end of study (approximately 10 years from LPI)
Secondary	Number of Participants with Clinically Meaningful Deterioration in Global Health Status/Quality of Life (GHS/QoL) Physical, Role, and Cognitive Function	Clinically Meaningful Deterioration will be Measured by Scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ C30)	From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)
Secondary	Mean Absolute Scores in GHS/QoL, Physical, Role, and Cognitive Function, as Assessed Using the EORTC QLQ-C30	The European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) is a self-reported measure. Functioning and symptoms items are scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. GHS and QoL items are scored on a 7-point scale: 1=Very poor, 2, 3, 4, 5, 6, 7=Excellent. Scores will be transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning, better GHS/QoL, and worse symptoms.	From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)
Secondary	Mean Change From Baseline Scores in GHS/QoL, Physical, Role, and Cognitive Function, as Assessed Using the EORTC QLQ-C30	The European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) is a self-reported measure. Functioning and symptoms items are scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. GHS and QoL items are scored on a 7-point scale: 1=Very poor, 2, 3, 4, 5, 6, 7=Excellent. Scores will be transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning, better GHS/QoL, and worse symptoms.	From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)
Secondary	Percentage of Participants with Adverse Events (AEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)		From baseline up to 10 years
Secondary	Maximum Serum Concentrations (Cmax) for Atezolizumab		Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, Day 1 of Cycles 2, 3 and 8 pre-infusion (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)
Secondary	Cmax for Trastuzumab Emtansine		Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)
Secondary	Cmax for Total Trastuzumab		Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)
Secondary	Cmax for DM1	DM1 = a thiol-containing maytansinoid anti-microtubule agent; N2'-deacetyl-N2'-(3-mercapto-1-oxopropyl)-maytansine	Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)
Secondary	Minimum Serum Concentrations (Cmin) for Atezolizumab		Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, Day 1 of Cycles 2, 3 and 8 (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)
Secondary	Percentage of Participants with Anti-drug Antibodies (ADAs) to Atezolizumab		Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, Day 1 of Cycles 2, 3 and 8 (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)
Secondary	Percentage of Participants with ADAs to Trastuzumab Emtansine		Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)