A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)

PHASE3CompletedINTERVENTIONAL
Enrollment

902

Participants

Timeline

Start Date

June 23, 2015

Primary Completion Date

April 14, 2020

Study Completion Date

August 31, 2021

Conditions
Triple Negative Breast Cancer
Interventions
DRUG

Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody

Atezolizumab at a fixed dose of 840 milligrams via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

DRUG

Nab-Paclitaxel

Nab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle. Nab-Paclitaxel was administered for a target of at least 6 cycles, with no maximum in the absence of disease progression or unacceptable toxicity.

DRUG

Placebo

Placebo administered via IV infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

Trial Locations (247)

100

National Taiwan Uni Hospital; General Surgery, Taipei

404

China Medical University Hospital; Surgery, Taichung

807

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

1000

Institute of Oncology Ljubljana, Ljubljana

1070

Institut Jules Bordet, Anderlecht

1090

Medizinische Universität Wien; Univ.Klinik für Innere Medizin I, Vienna

1122

Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly, Budapest

1145

Fövárosi Önkormányzat uzsoki utcai Kórház, Budapest

1200

Cliniques Universitaires St-Luc, Brussels

2050

Chris O'Brien Lifehouse, Camperdown

2610

Sint Augustinus Wilrijk, Wilrijk

2747

Nepean Cancer Care Centre, Sydney

3000

Peter MacCallum Cancer Centre; Medical Oncology, Melbourne

UZ Leuven Gasthuisberg, Leuven

3021

Sunshine Hospital, St Albans

3199

Peninsula and South Eastern Haematology and Oncology Group, Frankston

4010

Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1, Linz

4011

Stavanger Universitetssykehus, Helse Stavanger HF, Stavanger

4031

Universitaetsspital Basel; Onkologie, Basel

4101

Icon Cancer Foundation, South Brisbane

4102

Princess Alexandra Hospital; Division of Cancer Services, Woolloongabba

4400

A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie, Steyr

4604

Sørlandet Sykehus Kristiansand, Kristiansand

5417

Daugavpils Regional Hospital, Daugavpils

6000

GHdC Site Notre Dame, Charleroi

6008

St John of God Hospital; Bendat Cancer Centre, Subiaco

6720

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged

7100

Clinic of Oncology, University Clinical Center Sarajevo, Sarajevo

8036

Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I, Graz

8038

Universitätsspital Zürich, Zurich

8500

AZ Groeninge, Kortrijk

9007

Kantonsspital St.Gallen Brustzentrum/Chirurgie; Brustzentrum, Sankt Gallen

10016

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

10103

Clinica CIMCA, San José

10108

ICIMED Instituto de Investigación en Ciencias Médicas, San José

10400

Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc, Bangkok

10408

National Cancer Center, Goyang-si

10467

Montefiore Medical Center, The Bronx

10700

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok

11001

Clinica del Country, Bogotá

11042

ProHEALTH Care Associates LLP, Lake Success

13419

North Estonia Medical Centre Foundation; Oncology Centre, Tallinn

13581

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

14004

Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba

15213

Magee Womens Hospital, Pittsburgh

18015

St. Luke's Cancer Care Associates, Bethlehem

20007

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

20141

Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica, Milan

20246

Universitätsklinikum Hamburg-Eppendorf; Frauenklinik, Hamburg

20249

Facharztzentrum Eppendorf, Studien GbR, Hamburg

20850

Maryland Oncology Hematology, Rochville

21202

Mercy Medical Center, Baltimore

21287

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

22031

Inova Medical Group, Fairfax

23538

Universitätsklinikum Schleswig-Holstein; Campus Lübeck, Lübeck

25030

Hopital Jean Minjoz, Besançon

28000

Instituto Estatal de Cancerologia Colima, Colima

28041

Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid

28046

Hospital Universitario La Paz; Servicio de Oncologia, Madrid

29010

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Málaga

29605

Greenville Health System (GHS) Cancer Institute, Greenville

30060

Northwest Georgia Oncology Centers PC - Marietta, Marietta

32256

Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy), Jacksonville

33140

The Mount Siani Comprehensive Cancer Center, Miami Beach

33324

Florida Cancer Research Institute, Plantation

33520

Tampere University Hospital; Dept of Oncology, Tampere

33705

Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building), St. Petersburg

33901

Florida Cancer Specialists - SCRI; Pharmacy, Fort Myers

34098

Istanbul University Cerrahpasa Medical Faculty; Radiation Oncology Department, Istanbul

34214

Medipol University MF; Oncology Department, Istanbul

34298

Institut régional du Cancer Montpellier, Montpellier

35100

Ege Uni Medical Faculty Hospital; Oncology Dept, Izmir

35249

University of Alabama at Birmingham, Birmingham

37203

Sarah Cannon Cancer Center - Tennessee Oncology, Pllc, Nashville

37232

Vanderbilt, Nashville

37620

Wellmont Bristol Regional Medical Center, Bristol

38043

HOPITAL MICHALLON - CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE, Service d'oncologie Médicale, Grenoble

38138

West Clinic, Germantown

39202

Jackson Oncology Associates, PLLC, Jackson

43018

Treatment and Prevention Institution Volyn Regional Oncology Dispensary, Lutsk

43219

The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc., Columbus

44115

Institut De Cancerologie De L'Ouest; Medical Oncology, Saint-Herblain

44137

St. Johannes Hospital; Abt. für Hämatologie und Onkologie, Dortmund

44202

Clinique Catherine de Sienne, Nantes

45122

Uniklinik Essen; Gynäkologie, Essen

45242

Onc/Hem Care Clin Trials LLC, Cincinnati

45659

Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie, Recklinghausen

46009

Instituto Valenciano Oncologia; Oncologia Medica, Valencia

48153

Gemeinschaftspraxis für Hämatologie und Onkologie, Münster

48201

Barbara Ann Karmanos Cancer Institute; Oncology, Detroit

49000

Ico - Paul Papin, Angers

49007

West Michigan Cancer Center, Kalamazoo

49102

Chemotherapy SI Dnipropetrovsk MA of MOHU, Dnipropetrovsk

49124

Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH, Georgsmarienhütte

50935

St. Elisabeth-Krankenhaus; Brustzentrum, Cologne

51014

Tartu Uni Hospital; Hematology - Oncology Clinic, Tartu

53840

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

54290

Mutterhaus der Borromäerinnen gGmbH, Abteilung Hämatologie-Onkologie, Trier

56068

Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin, Koblenz

59020

Centre Oscar Lambret, Lille

60612

Rush University Medical Center - Chicago, Chicago

63110

Washington University School of Medicine, St Louis

64132

Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC, Kansas City

66278

Centro Médico Zambrano Hellion, Monterrey

67000

Centre Paul Strauss, Strasbourg

69008

Centre Leon Berard, Lyon

69120

Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen, Heidelberg

72076

Universitätsklinik Tübingen; Frauenklinik & Poliklinik, Tübingen

72762

Highlands Oncology Group, Springdale

75005

Institut Curie, Paris

75013

Hopital La Pitie Salpetriere, Paris

77030

The Methodist Cancer Center, Houston

University of Texas;M.D. Anderson Cancer Center, Houston

79031

Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv

79915

Texas Oncology- El Paso Cancer Treatment Center Gateway, El Paso

80014

Kaiser Permanente Of Colorado, Aurora

80131

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

81675

Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde, München

84082

Institut Sainte Catherine, Avignon

90110

Songklanagarind Hospital; Department of Oncology, Songkhla

91054

Universitätsklinikum Erlangen; Frauenklinik, Erlangen

92069

Kaiser Permanente - San Marcos, San Marcos

92373

Emad Ibrahim, Md, Inc, Redlands

92705

Cancer Research Collaboration, Inc., Santa Ana

94115

Univ of Calif, San Francisco; Breast Cancer Center, San Francisco

94612

Kaiser Permanente of Northern California, Oakland

97227

Kaiser Perm NW - Rheuma, Portland

97231

Providence Cancer Center, Portland

99204

Cancer Care Northwest, Spokane

99734

MVZ Nordhausen gGmbH, Praxis Dr. Grafe, Nordhausen

105229

Main Military Clinical Hospital named after N.N. Burdenko, Moscow

115478

Blokhin Cancer Research Center; Combined Treatment, Moskva

119074

National University Hospital, Singapore

143423

Moscow City Oncology Hospital #62, Moscovskaya Oblast

153040

Ivanovo Regional Oncology Dispensary, Ivanovo

163045

Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk

169610

National Cancer Centre, Singapore

197758

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

230002

Oncomedica S.A., Montería

300239

Oncomed SRL, Timișoara

420029

Clinical Oncology Dispensary of Ministry of Health of Tatarstan, Kazan'

546450

Euromedical General Clinic of Thessaloniki; Oncology Department, Thessaloniki

4810469

Sociedad de Investigaciones Medicas Ltda (SIM), Temuco

8330074

Centro de Cancer Pontificie Universidad Catolica de Chile, Santiago

94305-5821

Stanford Univ School of Med; Oncology, Stanford

06520

Yale Cancer Center; Medical Oncology, New Haven

06856

Norwalk Hospital, Norwalk

06904

Stamford Hospital; BCC, MOHR, Stamford

03103

New Hampshire Hematology Oncology, Manchester

07450

The Valley Hospital, Ridgewood

B1884BBF

Centro de Oncologia e Investigacion Buenos Aires (COIBA), Buenos Aires

C1125ABD

Fundación CENIT para la Investigación en Neurociencias, Buenos Aires

F5300COE

Centro Oncologico Riojano Integral (CORI), La Rioja

60336-550

Crio - Centro Regional Integrado de Oncologia, Fortaleza

40050-410

Santa Casa de Misericordia de Salvador, Salvador

74605-070

Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiânia

98700-000

Hospital de Caridade de Ijui; Oncologia, Ijuí

90035-903

Hospital das Clinicas - UFRGS, Porto Alegre

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

88034-000

Centro de Pesquisas Oncologicas - CEPON, Florianópolis

88301-220

Clinica de Neoplasias Litoral, Itajaí

01317-000

Hospital Perola Byington, São Paulo

01321-001

Hospital Sao Jose, São Paulo

T2N 4N2

Tom Baker Cancer Centre-Calgary, Calgary

T6G 1Z2

Cross Cancer Institute ; Dept of Medical Oncology, Edmonton

V1Y 5L3

BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre), Kelowna

V5Z 4E6

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre, Vancouver

B3H 2Y9

Queen Elizabeth II Health Sciences Centre; Oncology, Halifax

K7L 2V7

Kingston General Hospital, Kingston

L1G 2B9

Lakeridge Health Oshawa; Oncology, Oshawa

K2H 6C2

The Ottawa Hospital Cancer Centre, Ottawa

M4N 3M5

Sunnybrook Odette Cancer Centre, Toronto

H3T 1E2

Jewish General Hospital, Montreal

G1S 4L8

Hopital du Saint Sacrement, Québec

779 00

Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc

128 08

Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika, Prague

150 06

Fakultni nemocnice v Motole, Prague

01307

"Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden", Dresden

06120

Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie, Halle

115 22

Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine, Athens

155 62

IASO General Hospital of Athens, Athens

711 10

Univ General Hosp Heraklion; Medical Oncology, Heraklion

265 04

University Hospital of Patras Medical Oncology, Pátrai

01015

Grupo Angeles, Guatemala City

Unknown

Queen Mary Hospital; Dept of Medicine, Hong Kong

Helse Bergen HF Haukeland universitetssjukehus kreftavdelingen poliklinikk, Bergen

464-8681

Aichi Cancer Center Hospital, Aichi

960-1295

Fukushima Medical University Hospital, Fukushima

373-8550

Gunma Prefectural Cancer Center, Gunma

730-8518

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

734-8551

Hiroshima University Hospital, Hiroshima

003-0804

National Hospital Organization Hokkaido Cancer Center, Hokkaido

663-8501

Hyogo Medical University Hospital, Hyōgo

892-0833

Sagara Hospital, Kagoshima

216-8511

St. Marianna University Hospital, Kanagawa

259-1193

Tokai University Hospital, Kanagawa

860-8556

Kumamoto University Hospital, Kumamoto

606-8507

Kyoto University Hospital, Kyoto

514-8507

Mie University Hospital, Mie

980-8574

Tohoku University Hospital, Miyagi

951-8566

Niigata Cancer Center Hospital, Niigata

700-8558

Okayama University Hospital, Okayama

901-0154

Naha-nishi Clinic, Okinawa

540-0006

National Hospital Organization Osaka National Hospital, Osaka

541-8567

Osaka International Cancer Institute, Osaka

589-8511

Kindai University Hospital, Osaka

350-1298

Saitama Medical University International Medical Center, Saitama

362-0806

Saitama Cancer Center, Saitama

411-8777

Shizuoka Cancer Center, Shizuoka

104-0045

National Cancer Center Hospital, Tokyo

104-8560

St. Luke's International Hospital, Tokyo

113-8677

Komagome Hospital, Tokyo

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

LV-1079

Riga East Clinical University Hospital Latvian Oncology Centre, Riga

06760

Centro Medico Dalinde, Mexico City

04980

Iem-Fucam, D.F.

03100

Consultorio de Medicina Especializada; Dentro de Condominio San Francisco, Mexico City

0801

Centro Oncológico de Panamá, Panama City

85-796

Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii, Bydgoszcz

81-519

Szpitale Wojewodzkie w Gdyni Sp. z o.o., Gdynia

30-688

Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii, Krakow

20-090

Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii, Lublin

02-781

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

04-141

Wojskowy Instytut Medyczny, Warsaw

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08003

Hospital del Mar; Servicio de Oncologia, Barcelona

08035

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

08907

Hospital Duran i Reynals; Oncologia, Barcelona

118 83

Sodersjukhuset; Onkologkliniken, Stockholm

751 85

Akademiska sjukhuset, Onkologkliniken, Uppsala

00112

VETERANS GENERAL HOSPITAL; Department of General Surgery, Taipei

01330

Cukurova Uni Faculty of Medicine; Medical Oncology, Adana

06230

Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sihhiye/Ankara

03115

Kyiv City Clinical Oncological Center, Kyiv

CF14 2TL

Velindre Cancer Centre, Cardiff

EH4 2XU

Western General Hospital; Clinical Oncology, Edinburgh

EC1M 6BQ

St Bartholomew's Hospital, London

SE1 9RT

Guys ST Thomas Hospital, London

SW3 6JJ

Royal Marsden Hospital - London, London

M2O 4BX

Christie Hospital Nhs Trust; Medical Oncology, Manchester

PL6 8DH

Derriford Hospital, Plymouth

PR2 9HT

Royal Preston Hosptial, Preston

S10 2SJ

Weston Park Hospital, Sheffield

SM2 5PT

Royal Marsden Hospital; Dept of Medical Oncology, Sutton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02425891 - A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130) | Biotech Hunter | Biotech Hunter