A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

PHASE3CompletedINTERVENTIONAL
Enrollment

653

Participants

Timeline

Start Date

August 25, 2017

Primary Completion Date

November 15, 2019

Study Completion Date

January 17, 2023

Conditions
Triple-Negative Breast Cancer
Interventions
DRUG

Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody

Atezolizumab will be administered at a dose of 840 mg via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.

DRUG

Atezolizumab Placebo

Placebo matching to atezolizumab will be administered via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.

DRUG

Paclitaxel

Paclitaxel will be administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle.

Trial Locations (161)

2196

Sandton Oncology Medical Group, Sandton

10000

Clinical Hospital Centre Zagreb, Zagreb

Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie, Rabat

Dicle Uni Medical Faculty; Internal Medicine, Diyarbakır

10060

Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo, Candiolo

11525

King Fahad Medical City; Gastroentrology, Riyadh

13581

Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters, Berlin

14467

Klinikum Ernst von Bergmann; Frauenklinik, Potsdam

15006

Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia, A Coruña

15213

Magee-Woman's Hospital, Pittsburgh

16059

Uludag University Medical Faculty; Internal Medicine, Bursa

16132

A.O. Universitaria S. Martino Di Genova, Genoa

20089

IRCCS Istituto Clinico Humanitas; Oncologia, Rozzano (MI)

20132

Hospital San Raffaele, Milan

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

IEO Istituto Europeo di Oncologia;Divisione Oncologia Medica, Milan

21451

International Medical Center (IMC), Jeddah

22030

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

22767

HOPA im Struensee-Haus, Dres. Erik Engel, Wiebke Hollburg, Hamburg

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII), Bergamo

25030

HOPITAL JEAN MINJOZ; Oncologie, Besançon

25123

Asst Degli Spedali Civili Di Brescia, Brescia

28943

Hospital Universitario de Fuenlabrada; Servicio de Oncologia, Madrid

29200

Hopital Morvan, Brest

30029

Hopital Caremeau; Hematologie Oncologie, Nîmes

30060

Northwest Georgia Oncology Centers PC - Marietta, Marietta

31059

Institut Claudius Regaud; Departement Oncologie Medicale, Toulouse

31380

Kocaeli University Faculty of Medicine; Medical oncology, İzmit

31444

King Fahad Specialist Hospital; Oncology, Dammam

33300

Polyclinique Bordeaux Nord Aquitaine, Bordeaux

33604

Onkologische Schwerpunktpraxis Bielefeld, Bielefeld

33705

Florida Cancer Specialist, North Region, St. Petersburg

34722

Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology, Kadiköy

35037

OnkoNet Marburg GmbH, Marburg

35042

Centre Eugene Marquis; Service d'oncologie, Rennes

35128

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

35965

Izmir Ataturk Training and Research Hospital, Izmir

37203

Tennessee Oncology; Sarah Cannon Research Institute, Nashville

40000

Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie, Marrakesh

41009

Hospital Universitario Virgen Macarena; Servicio de Oncologia, Seville

41013

Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Seville

41110

Azienda Ospedaliero - Universitaria di Modena Policlinico, Modena

45136

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

48153

Gemeinschaftspraxis für Hämatologie und Onkologie, Münster

50134

Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia, Florence

50935

St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe, Cologne

53840

Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis, Troisdorf

54100

Centre D'Oncologie de Gentilly; Oncology, Nancy

55131

Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde, Mainz

57100

Ospedale Civile; Unita Operativa Di Oncologia Medica, Livorno

59020

Centre Oscar Lambret; Senologie, Lille

64132

HCA Midwest Health, Kansas City

66103

Fondazione Università G. D'Annunzio; Clinical Research Center (CRC); Centro Studi (CESI), Chieti

67065

Centre Paul Strauss; Oncologie Medicale, Strasbourg

69120

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

69373

Centre Leon Berard; Departement Oncologie Medicale, Lyon

70852

Fakultni nemocnice Ostrava; Klinika onkologicka FNO a LF OU, Ostrava-Poruba

72076

Universitätsklinik Tübingen; Frauenklinik, Tübingen

75020

Hopital Tenon, Paris

75231

Institut Curie; Oncologie Medicale, Paris

75475

Hopital Saint Louis, Service D Oncologie Medicale, Paris

75651

Ch Pitie Salpetriere; Oncologie Medicale, Paris

80027

Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia, Frattamaggiore

80131

Azienda Ospedaliera Universitaria Federico II, Napoli

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

80336

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

84918

Clinique Sainte Catherine; Hopital De Semaine, Avignon

85925

CHD Les Oudairies, La Roche-sur-Yon

94805

Institut Gustave Roussy; Sitep, Villejuif

98030

Ospedale S. Vincenzo; Oncologia Medica, Taormina

100000

K hospital, Hanoi

100021

Cancer Hospital Chinese Academy of Medical Sciences., Beijing

100730

Beijing Union Hospital, Beijing

110005

Dr. B L Kapur Memorial Hospital; BLK Cancer Centre, New Delhi

110042

Liaoning cancer Hospital & Institute, Shenyang

110076

Indraprastha Apollo Hospitals, New Delhi

110085

Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology, New Delhi

110088

Max Super Speciality Hospital; Medical Oncology, North WEST Delhi

115478

Russian Oncology Research Center n.a. N.N. Blokhin, Moscow

150081

Harbin Medical University Cancer Hospital, Harbin

197758

Petrov Research Inst. of Oncology, Saint Petersburg

200025

Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital), Shanghai

200120

Fudan University Shanghai Cancer Center, Shanghai

200347

Centrul de Oncologie Sfantul Nectarie, Craiova

210029

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University), Nanjing

211100

Jiangsu Cancer Hospital, Nanjing

250117

Shandong Cancer Hospital, Jinan

310022

Zhejiang Cancer Hospital, Zhejiang

400012

Tata Memorial Hospital; Dept of Medical Oncology, Mumbai

400015

Prof. Dr. I. Chiricuta Institute of Oncology, Cluj-Napoca

411001

Jehangir Hospital, Pune

450008

Henan Cancer Hospital, Zhengzhou

500082

Yashoda Hospital, Hyderabad

510000

Sun Yat-sen Memorial Hospital, Guangzhou

560017

Manipal Hospital; Department of Oncology, Bangalore

600035

Apollo Speciality Hospital, Chennai

610041

West China Hospital, Sichuan University; Department of Breast, Chengdu

700000

Hochiminh city oncology hospital, Hochiminh City

700054

Apollo Gleneagles Hospitals, Kolkata

700156

TATA Medical Centre; Medical Oncology, Kolkata

710004

The Second Affiliated Hospital of Xi'an Jiao Tong University, Xi'an

710061

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

1100092

MAX Balaji Hospital, Delhi

3000060

Tianjin Medical University Cancer Institute & Hospital, Tianjin

3525408

Rambam Health Corporation; Oncology Institute, Rambam

4941492

Rabin MC; Davidof Center - Oncology Institute, Petah Tikva

5262100

Sheba Medical Center, Ramat Gan

6093000

Assaf Harofeh; Oncology, Ẕerifin

6423906

Tel Aviv Sourasky Medical Ctr; Oncology, Tel Aviv

7610001

Kaplan Medical Center, Rehovot

9112000

Hadassah Ein Karem Hospital; Oncology Dept, Jerusalem

94305-5820

Stanford Cancer Center, Stanford

33901-8101

Florida Cancer Specialists; Department of Oncology, Fort Myers

07652

The Valley Hospital, Paramus

F5300COE

Centro Oncologico Riojano Integral (CORI), La Rioja

29308-014

Centro de Pesquisas Clinicas em Oncologia - CPCO, Cachoeiro de Itapemirim

40050-410

Santa Casa de Misericordia de Salvador, 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

T6G 1Z2

Cross Cancer Institute, Edmonton

K7L 2V7

Kingston General Hospital, Kingston

N2G 1G3

Grand River Hospital, Kitchener

N6A 4L6

London Regional Cancer Centre, London

M4N 3M5

Sunnybrook Odette Cancer Centre, Toronto

H4A 3J1

McGill University; Glen Site; Oncology, Montreal

G1S 4L8

Hopital du Saint Sacrement, Québec

J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont, Sherbrooke

050035

Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province), Shijiazhuang

500 05

Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology, Hradec Králové

779 00

Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc

128 08

Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika, Prague

115 22

Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine, Athens

115 28

ARETAIEION UNIVERSITY HOSPITAL; oncology unit, Athens

145 64

Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept., Kifissia

564 29

Papageorgiou General Hospital; Medical Oncology, Thessaloniki

00128

Universita Campus Bio-Medico di Roma (UCBM), Rome

00144

IRCCS Istituto Regina Elena (IFO); Oncologia Medica B, Rome

00161

Azienda Policlinico Umberto I, Rome

373-8550

Gunma Prefectural Cancer Center, Gunma

730-8518

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

892-0833

Sagara Hospital, Kagoshima

241-8515

Kanagawa Cancer Center, Kanagawa

259-1193

Tokai University Hospital, Kanagawa

951-8566

Niigata Cancer Center Hospital, Niigata

901-0154

Naha-nishi Clinic, Okinawa

541-8567

Osaka International Cancer Institute, Osaka

362-0806

Saitama Cancer Center, Saitama

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

833 10

Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A, Bratislava

058 01

POKO Poprad; Department of Oncology, Poprad

0001

Wilgers Oncology Centre, Pretoria

0081

Private Oncology Centre, Pretoria

08036

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

01220

Adana Baskent University Medical Faculty; Oncology, Adana

06490

Ankara Bilkent City Hospital, Ankara

SE1 9RT

Guys and St Thomas NHS Foundation Trust, Guys Hospital, London

M20 3BG

Christie Hospital, Manchester

HA6 2RN

Mount Vernon Cancer Centre, Northwood

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03125902 - A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) | Biotech Hunter | Biotech Hunter