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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,188

Participants

Timeline

Start Date

May 4, 2021

Primary Completion Date

August 31, 2028

Study Completion Date

October 2, 2034

Conditions
Breast Cancer
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.

Trial Locations (239)

100

National Taiwan University Hospital, Taipei

104

Mackay Memorial Hospital, Taipei

404

China Medical University Hospital, Taichung

600

Chia-Yi Christian Hospital, Chiayi City

704

National Cheng Kung Uni Hospital, Tainan City

852

Queen Mary Hospital, Hong Kong

1023

Auckland City Hospital, Cancer and Blood Research, Auckland

1032

Budapesti Szent Margit Korhaz, Budapest

1122

Orszagos Onkologiai Intezet, Budapest

1200

Cliniques Universitaires St-Luc, Brussels

1330

"Medical Center Nadezhda Clinical EOOD", Sofia

1527

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD, Sofia

2065

Royal North Shore Hospital, St Leonards

2560

Macarthur Cancer Therapy Centre, Campbelltown

3500

Jessa Zkh (Campus Virga Jesse), Hasselt

4004

COC Plovdiv, Plovdiv

4010

Ordensklinikum Linz Barmherzige Schwestern, Linz

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

4102

Princess Alexandra Hospital, Woolloongabba

5000

Clinique St. Elizabeth, Namur

5020

Lkh Salzburg - Univ. Klinikum Salzburg, Salzburg

6020

Tiroler Landeskrankenanstalten Ges.M.B.H., Innsbruck

7100

Vejle Sygehus, Vejle

10330

Chulalongkorn Hospital, Bangkok

10400

Ramathibodi Hospital, Bangkok

10408

National Cancer Center, Goyang-si

10707

Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin

11407

Hospital de Jerez de la Frontera, Jerez de la Frontera

13605

Seoul National University Bundang Hospital, Seongnam-si

14000

Instituto Nacional De Cancerologia, Distrito Federal

14076

Centre Francois Baclesse, Caen

14467

Klinikum Ernst von Bergmann, Potsdam

18016

Hospital Universitario Clínico San Cecilio, Granada

19106

Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit, Philadelphia

20132

Ospedale San Raffaele, Milan

20133

Irccs Istituto Nazionale Dei Tumori (Int), Milan

21005

Hospital Juan Ramon Jimenez, Huelva

21280

Dicle University Faculty of Medicine, Diyarbakır

21339

Städtische Klinik Lüneburg, Lüneburg

22030

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

22408

Hematology Oncology Associates of Fredericksburg, Inc., Fredericksburg

23007

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico, Jaén

23040

Investigacion Oncofarmaceutica, La Paz

23229

Virginia Cancer Institute, Richmond

23456

Virginia Oncology Associates - Virginia Beach, Virginia Beach

23502

Virginia Oncology Associates, Norfolk

23606

Virginia Oncology Associates - New Port News, Newport News

24105

UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe, Kiel

25011

Municipal Institution Kirovograd Regional Oncology Dispensary, Kirovograd

25030

CHRU Besançon, Besançon

25123

Asst Degli Spedali Civili Di Brescia, Brescia

26655

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

28007

Hospital General Universitario Gregorio Marañon, Madrid

28040

Hospital Clinico San Carlos, Madrid

28204

Levine Cancer Institute, Charlotte

28223

Hospital Quiron de Madrid, Madrid

29010

Hospital Clinico Universitario Virgen de la Victoria, Málaga

29609

CHU Brest Hopital La Cavale Blanche, Brest

30029

Centre Hospitalier Uni Ire Caremeau, Nîmes

30117

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital, Carrollton

30171

Diakovere Henriettenstift, Frauenklinik, Hanover

33081

Irccs Centro Di Riferimento Oncologico (CRO), Aviano

33300

Polyclinique Bordeaux Nord Aquitaine, Bordeaux

33401

Florida Cancer Specialists, West Palm Beach

34093

Istanbul Faculty of Medicine, Istanbul

34098

Istanbul University Cerrahpasa Faculty of Medicine, Istanbul

34662

Ac?badem Altunizade Hastanesi, Üsküdar

34730

Medeniyet University Goztepe Training and Research Hospital., Istanbul

35100

Ege University Medical Faculty, Bornova, ?zm?r

35205

Alabama Oncology, Birmingham

35360

Katip Celebi University Ataturk Training and Research Hospital, Izmir

36213

Hospital Alvaro Cunqueiro, Vigo

37007

Hospital Clinico Universitario de Salamanca, Salamanca

38138

The West Clinic, Germantown

38320

Hospital Universitario de Canarias, San Cristóbal de La Laguna

40002

Srinagarind Hospital, Khon Kaen

40005

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

40235

Gynonco Düsseldorf, MVZ Medical Center GmbH, Düsseldorf

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen del Rocio, Seville

41100

A.O. Universitaria Policlinico Di Modena, Modena

41404

Kyungpook National University Medical Center, Daegu

44280

Inonu University Medical Faculty of Medicine, Malatya

45136

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

46010

Hospital Clínico Universitario de Valencia, Valencia

46236

Marienhospital Bottrop, Bottrop

48013

Hospital de Basurto, Bilbao

49102

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

50009

Hospital Universitario Miguel Servet, Zaragoza

53111

Gynäkologisches Zentrum Bonn, Bonn

56100

Azlenda Ospendaliero-Universitaria Pisana, Pisa

57124

Ospedale Civile - Livorno, Livorno

60109

Groupe Hospitalier Public Du Sud De L'Oise GHPSO, Creil

60431

AGAPLESION Markus-Krankenhaus, Frankfurt

60596

Klinik Johann Wolfgang von Goethe Uni, Frankfurt

61070

Municipal Noncommercial Institution Regional Center of Oncology, Kharkiv

61231

Hochwaldkrankenhaus, Bad Nauheim

64460

Filios Alta Medicina, Monterrey

68020

Centro de Investigacion Clinica de Oaxaca, Oaxaca City

69008

CLCC Leon Berard Lyon, Lyon

75020

Groupe Hospitalier Diaconesses, Paris

75231

Institut Curie, Paris

78229

Mays Cancer Center at UT Health San Antonio MD Anderson Cancer, San Antonio

79110

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR, Freiburg im Breisgau

80131

U.O.C. Oncologia Medica Senologica, Napoli

Università degli Studi Federico II, Napoli

80336

Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt, München

83100

AORN'S.G.Moscati, Avellino

84918

Institut Sainte Catherine, Avignon

86021

Pole Regional De Cancerologie, Poitiers

86156

Klinikum Augsburg, Augsburg

88000

Uzhgorod Central City Clinical Hospital, Uzhhorod

90110

Songklanagarind Hospital, Songkhla

90404

UCLA Medical Center, Santa Monica

90603

Innovation Clinical Research Institute, Whittier

91505

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

92210

HOPITAL RENE HUGUENIN, Institut Curie, Saint-Cloud

97422

Leopoldina Krankenhaus der Stadt Schweinfurt GmbH, Schweinfurt

98201

Providence Regional Cancer Partnership, Everett

98405

Northwest Medical Specialties, Tacoma

99084

Frauenarztpraxis Dr. Apel, Dr. Kolpin, Erfurt

110085

Rajiv Gandhi Cancer Institute & Research Center, New Delhi

110088

Max Super Speciality Hospital, North WEST Delhi

111123

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

115478

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

143422

MEDSI Clinical Hospital on Pyatnitsky Highway, Moscow

150040

Regional Clinical Oncology Hospital, Yaroslavl

150081

Harbin Medical University Cancer Hospital, Harbin

168583

National Cancer Centre, Singapore

191104

SBI of Healthcare Leningrad Regional Oncology Dispensary, Saint Peterburg

196006

"Medical Clinic AB Medical group", Saint Petersburg

197758

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

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

200032

Zhongshan Hospital Fudan University, Shanghai

200347

Centrul de Oncologie Sfantul Nectarie, Craiova

248007

SBIH Kaluga Region Clinical Oncology Dispensary, Kaluga

300239

Oncomed SRL, Timișoara

310022

Zhejiang Cancer Hospital, Zhejiang

380054

Hemato Oncology Clinic Ahmedabad Pvt Ltd, Ahmedabad

400006

Cluj-Napoca Emergency Clinical County Hospital, Cluj-Napoca

400012

Tata Memorial Hospital, Mumbai

400015

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca, Cluj-Napoca

400030

Chongqing Cancer Hospital, Chongqing

407280

Amethyst Cluj, Cluj County

411028

Sahyadri Super Specialty Hospital Hadapsar, Pune

420029

Republican Clinical Oncological Dispensary of the Ministry of Healthcare, Kazan

422002

HCG Manavata Cancer Centre, Nashik

430022

Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

450008

Henan Cancer Hospital, Zhengzhou

510000

Sun Yat-sen Memorial Hospital, Guangzhou

510245

Guangdong Provincial People's Hospital, Guangzhou

560017

Manipal Hospital, Bangalore

603126

Nizhny Novgorod Regional Clinical Oncology Center, Nizhny Novgorod

610041

Sichuan Cancer Hospital, Chengdu

610047

West China Hospital - Sichuan University, Chengdu

630099

"LLC Medical and Sanitary Unit Clinician", Novosibirsk

632517

Christian Med Clg & Hspt, Ratnagiri Kilminnal

634063

Regional Oncology Dispensary, Tomsk

700156

TATA Medical Centre, Kolkata

710061

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

52242-1086

University of Iowa, Iowa City

04092

New England Cancer Specialists, Westbrook

07652

The Valley Hospital, Paramus

37916-2305

Thompson Cancer Survival Center, Knoxville

99336-7774

Kadlec Clinic Hematology and Oncology, Kennewick

60336-550

Crio - Centro Regional Integrado de Oncologia, Fortaleza

41253-190

Hospital Sao Rafael - HSR, Salvador

74605-070

Hospital Araujo Jorge, Goiânia

98700-000

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda, Ijuí

90020-090

Santa Casa de Misericordia de Porto Alegre, Porto Alegre

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao, Porto Alegre

15090-000

Hospital de Base de Sao Jose do Rio Preto, São José do Rio Preto

01317-001

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, São Paulo

03102-002

Núcleo de Pesquisa São Camilo, São Paulo

Unknown

The First Affilicated Hospital, Sun Yat-sen University, Guangzhou

Tianjin Medical University Cancer Institute & Hospital, Tianjin

Pamela Youde Nethersole Eastern Hospital, Hong Kong

Tuen Mun Hospital, Hong Kong

656 53

Masaryk?v onkologický ústav, Brno

500 05

Fakultni Nemocnice Hradec Kralove, Hradec Králové

741 01

Nemocnice AGEL Novy Jicin a.s., Nový Jičín

779 00

Fakultni nemocnice Olomouc, Olomouc

128 08

Fakultni Poliklinika Vseobecne Fakultni Niemocnice, Prague

140 59

Fakultni Thomayerova nemocnice, Praha 4 - Krc

06847

Städtisches Klinikum Dessau, Dessau

115 22

Anticancer Hospital Ag. Savas, Athens

115 28

Alexandras General Hospital of Athens, Athens

711 10

University General Hospital of Heraklion, Crete

411 10

University Hospital of Larissa, Larissa

185 47

Metropolitan Hospital, Piraeus

570 01

European Interbalkan Medical Center, Thessaloniki

00168

Policlinico Universitario Agostino Gemelli, Rome

00100

Aga Khan University Hospital, Nairobi

03100

Health Pharma Professional Research, Mexico City

06760

Centro Medico Dalinde, Mexico City

15-027

Bialostockie Centrum Onkologii, Bialystok

80-214

Uniwersyteckie Centrum Kliniczne, Gda?sk

44-102

Narodowy Instytut Onkologii Odzia? w Gliwicach, Gliwice

30-688

Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii, Krakow

61-866

Wielkopolskie Centrum Onkologii, Poznan

02-781

Centrum Onkologii Instytut im.M. Sklodowskiej-Curie, Warsaw

1350-352

Hospital CUF Tejo, Lisbon

1649-035

Hospital de Santa Maria, Lisbon

2674-514

Hospital Beatriz Angelo, Loures

4200-072

IPO do Porto, Porto

021164

Filantropia Clinical Hospital, Bucharest

(0)6351

Samsung Medical Center, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06273

Gangnam Severance Hospital, Seoul

06591

Seoul St Mary's Hospital, Seoul

08308

Korea University Guro Hospital, Seoul

03203

Hospital General Universitario de Elche, Elche

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08208

Corporacio Sanitaria Parc Tauli, Sabadell

00112

Taipei Veterans General Hospital, Taipei

01120

Adana Baskent University Hospital, Adana

06100

Hacettepe University Medical Faculty, Ankara

06490

Ankara Bilkent City Hospital, Ankara

06500

Gazi University Medical Faculty, Oncology Hospital, Ankara

06520

Memorial Ankara Hastanesi, Ankara

07100

Antalya Training and Research Hospital, Antalya

01140

Medical Park Seyhan Hospital, Seyhan

00256

Uganda Cancer Institute, Kampala

03115

Kyiv City Clinical Oncological Center, Kyiv

FY3 8NR

Blackpool Victoria Hospital, Blackpool

BN2 5BE

Royal Sussex County Hospital, Brighton

CB2 0QQ

Addenbrookes Hospital, Cambridge

GL53 7AN

Cheltenham General Hospital, Cheltenham

EC1A 7BE

Barts & London School of Med, London

NW1 - 2PG

University College London Hospital, London

NW3 2QS

Royal Free Hospital, London

SW3 6JJ

Royal Marsden Hospital - London, London

M20 4BX

Christie Hospital NHS Trust, Manchester

HA6 2RN

Mount Vernon Cancer Centre, Northwood

PR2 9HT

Royal Preston Hospital, Preston

TR1 3LJ

Royal Cornwall Hospital, Truro

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04873362 - 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 | Biotech Hunter | Biotech Hunter