A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

202

Participants

Timeline

Start Date

September 26, 2016

Primary Completion Date

December 11, 2017

Study Completion Date

February 6, 2020

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Atezolizumab

Atezolizumab 1200 mg IV infusion

DRUG

Trastuzumab emtansine

Trastuzumab emtansine 3.6 mg/kg IV infusion

OTHER

Placebo

Placebo matched to atezolizumab

Trial Locations (68)

100

National Taiwan Uni Hospital; General Surgery, Taipei

333

Chang Gung Memorial Hospital - Linkou, Taoyuan District

404

China Medical University Hospital; Surgery, Taichung

500

Changhua Christian Hospital; Dept of Surgery, Changhua

736

Chi-Mei Medical Center, Tainan City

807

Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery, Kaohsiung City

2217

St George Hospital; Cancer Care Centre, Kogarah

2298

Calvary Mater Newcastle, Waratah

3002

Peter MacCallum Cancer Center, East Melbourne

3021

Sunshine Hospital, St Albans

3199

Peninsula and South Eastern Haematology and Oncology Group, Frankston

4102

Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology, Woolloongabba

6008

St John of God Hospital; Bendat Cancer Centre, Subiaco

10016

Laura and ISAAC Perlmutter Cancer Center at NYU Langone., New York

10408

National Cancer Center, Goyang-si

11259

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

13125

HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe, Berlin

14004

Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba

14169

Studienzentrum Berlin City, Berlin

15006

Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología, A Coruña

15213

Magee Womens Hospital, Pittsburgh

17403

Cancer Care Associates of York, York

20007

MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center), Washington D.C.

21231

Johns Hopkins Univ Med Center, Baltimore

28034

Hospital Ramon y Cajal; Servicio de Oncologia, Madrid

30342

Northside Hospital, Atlanta

33081

Centro Di Riferimento Oncologico; SOC Oncologia Medica C, Aviano

33719

Florida Cancer Specialists; Saint Petersburg, St. Petersburg

33916

SCRI Florida Cancer Specialists South, Fort Myers

37203

Tennessee Oncology; Sarah Cannon Research Institute, Nashville

37404

SCRI Tennessee Oncology Chattanooga, Chattanooga

40138

A.O.U Policlinico S. Orsola Malpighi di Bologna U.O di Medicina Interna Borghi - Pad.2, Bologna

43100

Ospedale Regionale Di Parma; Divisione Di Oncologia Medica, Parma

43210

Ohio State Uni Medical Center, Columbus

45136

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

46010

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia

46015

Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia, Valencia

56068

Institut für Versorgungsforschung in der Onkologie GbR Koblenz, Koblenz

59100

Ospedale Santo Stefano, Azienda USL Centro Prato, Prato

69120

Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg, Heidelberg

79110

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR, Freiburg im Breisgau

80045

University of Colorado, Aurora

80131

IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A, Napoli

87401

San Juan Oncology Associates, Farmington

92868

Breastlink Med Group Inc, Orange

95126

Centro Catanese Di Oncologia; Oncologia Medica, Catania

98195

University of Washington, Seattle

L1G 2B9

Lakeridge Health Oshawa; Oncology, Oshawa

K1H 8L6

The Ottawa Hospital Cancer Centre; Oncology, Ottawa

M4N 3M5

Sunnybrook Odette Cancer Centre, Toronto

H3T 1E2

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal

H4A 3J1

McGill University; Glen Site; Oncology, Montreal

G1S 4L8

Hopital du Saint Sacrement, Québec

(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

08035

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona

00112

VETERANS GENERAL HOSPITAL; Department of General Surgery, Taipei

BA1 3NG

Royal United Hospital; Oncology Department, Bath

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

NW3 2QG

Royal Free Hospital; Dept of Oncology, London

SW3 6JJ

Royal Marsden Hosp NHS Fnd; Breast Unit, London

M20 4QL

Christie Hospital; Breast Cancer Research Office, Manchester

NG5 1PB

Nottingham City Hospital, Nottingham

S10 2SJ

Weston Park Hospital; Cancer Clinical Trials Centre, Sheffield

SM2 5PT

Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit, Sutton

SA2 8QA

Singleton Hospital; Pharmacy, Swansea

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02924883 - A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy | Biotech Hunter | Biotech Hunter