A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

454

Participants

Timeline

Start Date

January 11, 2019

Primary Completion Date

February 5, 2021

Study Completion Date

August 24, 2023

Conditions
Breast Cancer
Interventions
DRUG

Atezolizumab

Atezolizumab will be administered as per the schedule specified in the respective arm.

DRUG

Placebo

Placebo matched to atezolizumab will be administered as per the schedule specified in the respective arm.

DRUG

Doxorubicin

Doxorubicin will be administered as per the schedule specified in the respective arm.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered as per the schedule specified in the respective arm.

DRUG

Paclitaxel

Paclitaxel will be administered as per the schedule specified in the respective arm.

DRUG

Trastuzumab

Trastuzumab will be administered as per the schedule specified in the respective arm.

DRUG

Pertuzumab

Pertuzumab will be administered as per the schedule specified in the respective arm.

DRUG

Trastuzumab Emtansine

Participants without pCR have the option of receiving adjuvant atezolizumab/placebo combined with Trastuzumab Emtansine 3.6 mg/kg IV Q3W.

Trial Locations (76)

104

Mackay Memorial Hospital; Dept of Surgery, Taipei

333

Chang Gung Medical Foundation - Linkou; Dept of Surgery, Taoyuan District

404

China Medical University Hospital; Surgery, Taichung

10016

New York University Medical Center PRIME; NYU Langone Medical Center, New York

10060

Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico, Candiolo

11259

Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology, Taipei

18016

Hospital Clinico de Granada; Servicio de Oncologia, Granada

20089

Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia, Rozzano

20357

Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem, Hamburg

20900

ASST DI MONZA; Oncologia Medica, Monza

21565

Gachon University Gil Medical Center, Incheon

23007

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia, Jaén

25123

ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica, Brescia

25198

Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia, Lleida

28027

Clinica Universidad de Navarra Madrid; Servicio de Oncología, Madrid

28050

Centro Integral Oncologico Clara Campal; Servicio de Oncología, Madrid

30120

Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia, El Palmar

31008

Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona

33081

Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica, Aviano

33098

St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik, Paderborn

35128

IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padua

37203

Tennessee Oncology - Nashville, Nashville

41009

Hospital Universitario Virgen Macarena; Servicio de Oncologia, Seville

41013

Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Seville

45136

Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum, Essen

48149

Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe, Münster

64132

HCA Midwest Division, Kansas City

79110

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR, Freiburg im Breisgau

80131

Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica, Napoli

Università degli Studi Federico II; Clinica di Oncologia Medica, Napoli

80637

Rotkreuzklinikum München; Frauenklinik, München

89075

Universitätsfrauenklinik Ulm; Abteilung Gynäkologie, Ulm

111123

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

115478

Blokhin Cancer Research Center; Combined Treatment, Moskva

143423

City Clinical Oncology Hospital, Moscow

197758

Petrov Research Inst. of Oncology, Saint Petersburg

249036

FSBI National Medical Research Radiological Center; A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER, Obninsk

420029

Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic, Kazan'

41253-190

Hospital Sao Rafael - HSR, Salvador

74605-070

Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiânia

90040-373

Hospital Nossa Senhora da Conceicao, Porto Alegre

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

01317-000

Hospital Perola Byington, São Paulo

T2N 4N2

Tom Baker Cancer Centre-Calgary, Calgary

V5Z 4E6

BCCA-Vancouver Cancer Centre, Vancouver

H3T 1E2

Jewish General Hospital, Montreal

G1S 4L8

Hopital du Saint Sacrement, Québec

656 53

Masarykuv onkologicky ustav, Brno

779 00

Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc

04277

Sankt Elisabeth Krankenhaus; Gynaekology, Leipzig

00168

Policlinico Universitario Agostino Gemelli, Rome

791-0280

National Hospital Organization Shikoku Cancer Center, Ehime

730-8518

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

734-8551

Hiroshima University Hospital, Hiroshima

003-0804

National Hospital Organization Hokkaido Cancer Center, Hokkaido

673-0021

Hyogo Cancer Center, Hyōgo

241-8515

Kanagawa Cancer Center, Kanagawa

259-1193

Tokai University Hospital, Kanagawa

862-8655

Kumamoto Shinto General Hospital, Kumamoto

960-1295

Fukushima Medical University Hospital, Miyagi

951-8566

Niigata Cancer Center Hospital, Niigata

350-1298

Saitama Medical University International Medical Center, Saitama

105-8470

Toranomon Hospital, Tokyo

142-8666

Showa University Hospital, Tokyo

93-338

"Instytut Centrum Zdrowia Matki Polki; Klinika Onkologii", ?ód?

44-101

Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi, Gliwice

86-300

Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej, Grudzi?dz

30-688

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

02-781

Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr, Warsaw

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

135-170

Samsung Medical Centre; Oncology, Seoul

08916

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Badalona

08740

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de la Barca

08036

Hospital Clínic i Provincial; Servicio de Hematología y Oncología, Barcelona

09006

Complejo Asistencial Universitario De Burgos; Servicio de Oncologia, Burgos

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Chugai Pharmaceutical

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY