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ACTIVE NOT RECRUITING
NCT04873362
PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1188

Start Date

2021-05-04

Completion Date

2034-10-02

Last Updated

2026-03-04

Healthy Volunteers

No

Conditions

Interventions

DRUG

Atezolizumab

Atezolizumab will be administered at a dose of 1200 mg every three weeks (Q3W) for 14 cycles.

DRUG

Trastuzumab Emtansine

Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.

DRUG

Placebo

Placebo matched to atezolizumab will be administered at a dose of 1200 mg Q3W for 14 cycles.

DRUG

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 (238)

Alabama Oncology

Birmingham, Alabama, United States

Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center

Buena, California, United States

UCLA Medical Center

Santa Monica, California, United States

Innovation Clinical Research Institute

Whittier, California, United States

Florida Cancer Specialists

West Palm Beach, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Carrollton, Georgia, United States

University of Iowa

Iowa City, Iowa, United States

New England Cancer Specialists

Westbrook, Maine, United States

The Valley Hospital

Paramus, New Jersey, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit

Philadelphia, Pennsylvania, United States

The West Clinic

Germantown, Tennessee, United States

Thompson Cancer Survival Center

Knoxville, Tennessee, United States

Mays Cancer Center at UT Health San Antonio MD Anderson Cancer

San Antonio, Texas, United States

Hematology Oncology Associates of Fredericksburg, Inc.

Fredericksburg, Virginia, United States

Virginia Oncology Associates - New Port News

Newport News, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Virginia Cancer Institute

Richmond, Virginia, United States

Virginia Oncology Associates - Virginia Beach

Virginia Beach, Virginia, United States

Providence Regional Cancer Partnership

Everett, Washington, United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, United States

Northwest Medical Specialties

Tacoma, Washington, United States

Macarthur Cancer Therapy Centre

Campbelltown, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Tiroler Landeskrankenanstalten Ges.M.B.H.

Innsbruck, Austria

Ordensklinikum Linz Barmherzige Schwestern

Linz, Austria

Lkh Salzburg - Univ. Klinikum Salzburg

Salzburg, Austria

Cliniques Universitaires St-Luc

Brussels, Belgium

Jessa Zkh (Campus Virga Jesse)

Hasselt, Belgium

Clinique St. Elizabeth

Namur, Belgium

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Hospital Sao Rafael - HSR

Salvador, Estado de Bahia, Brazil

Hospital Araujo Jorge

Goiânia, Goiás, Brazil

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

São Paulo, São Paulo, Brazil

Núcleo de Pesquisa São Camilo

São Paulo, São Paulo, Brazil

COC Plovdiv

Plovdiv, Bulgaria

Medical Center "Nadezhda Clinical" EOOD

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

Sofia, Bulgaria

Sichuan Cancer Hospital

Chengdu, China

West China Hospital - Sichuan University

Chengdu, China

Chongqing Cancer Hospital

Chongqing, China

Sun Yat-sen Memorial Hospital

Guangzhou, China

Guangdong Provincial People's Hospital

Guangzhou, China

The First Affilicated Hospital, Sun Yat-sen University

Guangzhou, China

Harbin Medical University Cancer Hospital

Harbin, 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, China

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, China

Zhejiang Cancer Hospital

Zhejiang, China

Henan Cancer Hospital

Zhengzhou, China

Masaryk?v onkologický ústav

Brno, Czechia

Fakultni Nemocnice Hradec Kralove

Hradec Králové, Czechia

Nemocnice AGEL Novy Jicin a.s.

Nový Jičín, Czechia

Fakultni nemocnice Olomouc

Olomouc, Czechia

Fakultni Poliklinika Vseobecne Fakultni Niemocnice

Prague, Czechia

Fakultni Thomayerova nemocnice

Praha 4 - Krc, Czechia

Vejle Sygehus

Vejle, Denmark

Institut Sainte Catherine

Avignon, France

CHRU Besançon

Besançon, France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France

CHU Brest Hopital La Cavale Blanche

Brest, France

Centre Francois Baclesse

Caen, France

Groupe Hospitalier Public Du Sud De L'Oise GHPSO

Creil, France

CLCC Leon Berard Lyon

Lyon, France

Centre Hospitalier Uni Ire Caremeau

Nîmes, France

Groupe Hospitalier Diaconesses

Paris, France

Institut Curie

Paris, France

Pole Regional De Cancerologie

Poitiers, France

HOPITAL RENE HUGUENIN, Institut Curie

Saint-Cloud, France

Klinikum Augsburg

Augsburg, Germany

Hochwaldkrankenhaus

Bad Nauheim, Germany

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, Germany

Gynäkologisches Zentrum Bonn

Bonn, Germany

Knappschaft Kliniken Marienhospital Bottrop

Bottrop, Germany

Städtisches Klinikum Dessau

Dessau, Germany

Gynonco Düsseldorf, MVZ Medical Center GmbH

Düsseldorf, Germany

Frauenarztpraxis Dr. Apel, Dr. Kolpin

Erfurt, Germany

Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH

Essen, Germany

AGAPLESION Markus-Krankenhaus

Frankfurt, Germany

Klinik Johann Wolfgang von Goethe Uni

Frankfurt, Germany

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

Freiburg im Breisgau, Germany

Diakovere Henriettenstift, Frauenklinik

Hanover, Germany

UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

Kiel, Germany

Städtische Klinik Lüneburg

Lüneburg, Germany

Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

München, Germany

Klinikum Ernst von Bergmann

Potsdam, Germany

Leopoldina Krankenhaus der Stadt Schweinfurt GmbH

Schweinfurt, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie Dr. Reichert/Dr.Janssen

Westerstede, Germany

Anticancer Hospital Ag. Savas

Athens, Greece

Alexandras General Hospital of Athens

Athens, Greece

University General Hospital of Heraklion

Crete, Greece

University Hospital of Larissa

Larissa, Greece

Metropolitan Hospital

Piraeus, Greece

European Interbalkan Medical Center

Thessaloniki, Greece

Queen Mary Hospital

Hong Kong, Hong Kong

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Tuen Mun Hospital

Hong Kong, Hong Kong

Budapesti Szent Margit Korhaz

Budapest, Hungary

Orszagos Onkologiai Intezet

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

Hemato Oncology Clinic Ahmedabad Pvt Ltd

Ahmedabad, Gujarat, India

Manipal Hospital

Bangalore, Karnataka, India

Tata Memorial Hospital

Mumbai, Maharashtra, India

HCG Manavata Cancer Centre

Nashik, Maharashtra, India

Sahyadri Super Specialty Hospital Hadapsar

Pune, Maharashtra, India

Rajiv Gandhi Cancer Institute & Research Center

New Delhi, National Capital Territory of Delhi, India

Max Super Speciality Hospital

North WEST Delhi, National Capital Territory of Delhi, India

Christian Med Clg & Hspt

Ratnagiri Kilminnal, Tamil Nadu, India

TATA Medical Centre

Kolkata, West Bengal, India

AORN'S.G.Moscati

Avellino, Campania, Italy

U.O.C. Oncologia Medica Senologica

Naples, Campania, Italy

Università degli Studi Federico II

Naples, Campania, Italy

A.O. Universitaria Policlinico Di Modena

Modena, Emilia-Romagna, Italy

Irccs Centro Di Riferimento Oncologico (CRO)

Aviano, Friuli Venezia Giulia, Italy

Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, Italy

Ospedale San Raffaele

Milan, Lombardy, Italy

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Lombardy, Italy

Ospedale Civile - Livorno

Livorno, Tuscany, Italy

Azlenda Ospendaliero-Universitaria Pisana

Pisa, Tuscany, Italy

The Aga Khan University-Kenya.

Nairobi, Kenya

Investigacion Oncofarmaceutica

La Paz, Baja California Sur, Mexico

Instituto Nacional De Cancerologia

Distrito Federal, Mexico CITY (federal District), Mexico

Health Pharma Professional Research

Mexico City, Mexico CITY (federal District), Mexico

Centro Medico Dalinde

Mexico City, Mexico CITY (federal District), Mexico

Filios Alta Medicina

Monterrey, Nuevo León, Mexico

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, Oaxaca, Mexico

Auckland City Hospital, Cancer and Blood Research

Auckland, New Zealand

Bialostockie Centrum Onkologii

Bialystok, Poland

Uniwersyteckie Centrum Kliniczne

Gda?sk, Poland

Narodowy Instytut Onkologii Odzia? w Gliwicach

Gliwice, Poland

Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

Krakow, Poland

Wielkopolskie Centrum Onkologii

Poznan, Poland

Centrum Onkologii Instytut im.M. Sklodowskiej-Curie

Warsaw, Poland

Hospital CUF Tejo

Lisbon, Portugal

Hospital de Santa Maria

Lisbon, Portugal

Hospital Beatriz Angelo

Loures, Portugal

IPO do Porto

Porto, Portugal

Filantropia Clinical Hospital

Bucharest, Romania

Amethyst Cluj

Cluj County, Romania

Cluj-Napoca Emergency Clinical County Hospital

Cluj-Napoca, Romania

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

Cluj-Napoca, Romania

Centrul de Oncologie Sfantul Nectarie

Craiova, Romania

Oncomed SRL

Timișoara, Romania

FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

Moscow, Moscow Oblast, Russia

MEDSI Clinical Hospital on Pyatnitsky Highway

Moscow, Moscow Oblast, Russia

SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

Moskva, Moscow Oblast, Russia

Nizhny Novgorod Regional Clinical Oncology Center

Nizhny Novgorod, Niznij Novgorod, Russia

Republican Clinical Oncological Dispensary of the Ministry of Healthcare

Kazan, Republic of Karelia, Russia

SBI of Healthcare Leningrad Regional Oncology Dispensary

Saint Peterburg, Sankt-Peterburg, Russia

Medical Clinic "AB Medical group"

Saint Petersburg, Sankt-Peterburg, Russia

FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF

Saint Petersburg, Sankt-Peterburg, Russia

S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

Saint Petersburg, Sankt-Peterburg, Russia

SBIH Kaluga Region Clinical Oncology Dispensary

Kaluga, Russia

LLC Medical and Sanitary Unit "Clinician"

Novosibirsk, Russia

Regional Oncology Dispensary

Tomsk, Russia

Regional Clinical Oncology Hospital

Yaroslavl, Russia

National Cancer Centre

Singapore, Singapore

Kyungpook National University Medical Center

Daegu, South Korea

National Cancer Center

Goyang-si, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Samsung Medical Center

Seoul, 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

Seoul St Mary's Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Hospital General Universitario de Elche

Elche, Alicante, Spain

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Hospital de Jerez de la Frontera

Jerez de la Frontera, Cadiz, Spain

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Hospital de Basurto

Bilbao, Vizcaya, Spain

Hospital Universitario Clínico San Cecilio

Granada, Spain

Hospital Juan Ramon Jimenez

Huelva, Spain

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

Jaén, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Quiron de Madrid

Madrid, Spain

Hospital Clinico Universitario Virgen de la Victoria

Málaga, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung Uni Hospital

Tainan, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan

Chulalongkorn Hospital

Bangkok, Thailand

Ramathibodi Hospital

Bangkok, Thailand

Srinagarind Hospital

Khon Kaen, Thailand

Songklanagarind Hospital

Songkhla, Thailand

Adana Baskent University Hospital

Adana, Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Gazi University Medical Faculty, Oncology Hospital

Ankara, Turkey (Türkiye)

Memorial Ankara Hastanesi

Ankara, Turkey (Türkiye)

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Ege University Medical Faculty

Bornova, ?zm?r, Turkey (Türkiye)

Dicle University Faculty of Medicine

Diyarbakır, Turkey (Türkiye)

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

Edirne, Turkey (Türkiye)

Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Istanbul University Cerrahpasa Faculty of Medicine

Istanbul, Turkey (Türkiye)

Medeniyet University Goztepe Training and Research Hospital.

Istanbul, Turkey (Türkiye)

Katip Celebi University Ataturk Training and Research Hospital

Izmir, Turkey (Türkiye)

Inonu University Medical Faculty of Medicine

Malatya, Turkey (Türkiye)

Medical Park Seyhan Hospital

Seyhan, Turkey (Türkiye)

Ac?badem Altunizade Hastanesi

Üsküdar, Turkey (Türkiye)

Uganda Cancer Institute

Kampala, Uganda

Uzhgorod Central City Clinical Hospital

Uzhhorod, Katerynoslav Governorate, Ukraine

Municipal Noncommercial Institution Regional Center of Oncology

Kharkiv, Kharkiv Governorate, Ukraine

Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp

Sumy, Kholm Governorate, Ukraine

CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR

Dnipropetrovsk, Ukraine

Municipal Institution Kirovograd Regional Oncology Dispensary

Kirovograd, Ukraine

Kyiv City Clinical Oncological Center

Kyiv, Ukraine

Blackpool Victoria Hospital

Blackpool, United Kingdom

Royal Sussex County Hospital

Brighton, United Kingdom

Addenbrookes Hospital

Cambridge, United Kingdom

Cheltenham General Hospital

Cheltenham, United Kingdom

Barts & London School of Med

London, United Kingdom

University College London Hospital

London, United Kingdom

Royal Free Hospital

London, United Kingdom

Royal Marsden Hospital - London

London, United Kingdom

Christie Hospital NHS Trust

Manchester, United Kingdom

Mount Vernon Cancer Centre

Northwood, United Kingdom

Royal Preston Hospital

Preston, United Kingdom

Royal Cornwall Hospital

Truro, United Kingdom