A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

333

Participants

Timeline

Start Date

July 24, 2017

Primary Completion Date

April 3, 2020

Study Completion Date

September 28, 2022

Conditions
Triple-negative Breast Cancer
Interventions
DRUG

Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody

Atezolizumab was administered as per schedule described in respective arm.

DRUG

Placebo

Placebo matched to atezolizumab was administered as per schedule described in respective arm.

DRUG

Nab-paclitaxel

Nab-paclitaxel was administered as per schedule described in the arms.

DRUG

Doxorubicin

Doxorubicin was administered as per schedule described in the arms.

DRUG

Cyclophosphamide

Cyclophosphamide was administered as per schedule described in the arms.

DRUG

Filgrastim

Filgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.

DRUG

Pegfilgrastim

Pegfilgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.

Trial Locations (68)

104

Mackay Memorial Hospital; Dept of Surgery, Taipei

333

Chang Gung Medical Foundation Linkou Branch, Taoyuan

1200

Cliniques Universitaires St-Luc, Brussels

2610

Sint Augustinus Wilrijk, Wilrijk

3000

UZ Leuven Gasthuisberg, Leuven

3168

Monash Medical Centre, Clayton

5000

Clinique Ste-Elisabeth, Namur

6149

Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit, Bull Creek

10065

Memorial Sloan Kettering Cancer Center, New York

10367

Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare), Berlin

10408

National Cancer Center, Goyang-si

13581

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

20132

Irccs Ospedale San Raffaele, Milan

20357

Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem, Hamburg

20900

Ospedale San Gerardo, Monza

21202

Mercy Medical Center, Baltimore

26133

Medizinisches Versorgungszentrum am Klinikum Oldenburg GmbH, Oldenburg

28041

Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid

30117

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

30559

Diakovere Henriettenstift, Frauenklinik, Hanover

33604

Onkologische Schwerpunktpraxis Bielefeld, Bielefeld

36100

Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza, Vicenza

37203

Tennessee Oncology, Nashville

37204

Vanderbilt Breast Center at One Hundred Oaks, Nashville

37404

Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street, Chattanooga

40235

Luisenkrankenhaus GmbH & Co. KG., Brustzentrum, Düsseldorf

41013

Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Seville

45879

Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum, Gelsenkirchen

48149

Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe, Münster

61231

Hochwaldkrankenhaus, Bad Nauheim

63225

Dres. Andreas Köhler und Roswitha Fuchs, Langen

64132

HCA Midwest Division, Kansas City

76104

The Center for Cancer and Blood Disorders - Fort Worth, Fort Worth

80336

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

94304

Stanford University Medical Center, Palo Alto

99204

Cancer Care Northwest, Spokane

06856

Norwalk Hospital, Norwalk

07652

The Valley Hospital; Valley Medical Group, Paramus

40050-410

Santa Casa de Misericordia de Salvador, Salvador

74605-070

Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiânia

38082-049

CETUS Hospital Dia Oncologia, Uberaba

80530-010

Iop Instituto de Oncologia Do Parana, Curitiba

22290-160

Clinicas Oncologicas Integradas - COI, Rio de Janeiro

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao, Porto Alegre

01317-001

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

H3T 1E2

Jewish General Hospital, Montreal

H4J 1C5

Hopital Sacre-Coeur Research Centre, Montreal

G1S 4L8

Hopital du Saint Sacrement, Québec

04277

St. Elisabeth-Krankenhaus, Senologie/Brustzentrum, Leipzig

464-8681

Aichi Cancer Center Hospital, Aichi

791-0280

National Hospital Organization Shikoku Cancer Center, Ehime

960-1295

Fukushima Medical University Hospital, Fukushima

730-8518

Hiroshima City Hiroshima Citizens Hospital; Breast Surgery, Hiroshima

241-8515

Kanagawa Cancer Center, Kanagawa

259-1193

Tokai University Hospital, Kanagawa

540-0006

National Hospital Organization Osaka National Hospital; Breast Surgery, Osaka

104-8560

St. Luke's Internat. Hospital, Breast Surgical Oncology, Tokyo

135-8550

The Cancer Inst. Hosp. of JFCR; Breast Oncology Center, Tokyo

02-781

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

53-413

Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii; Oddz. Onkologii Klin. i Chemioterapii, Wroc?aw

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

00112

VETERANS GENERAL HOSPITAL; Department of General Surgery, Taipei

LE1 5WW

Leicester Royal Infirmary, Leicester

EC1A 7BE

Barts & London School of Med; Medical Oncology, London

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03197935 - A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer | Biotech Hunter | Biotech Hunter