AzTrials
AzTrials

Triple Negative Breast CancerPhase 3NCT02425891

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)

A Phase 3 study testing Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody and Nab-Paclitaxel in people with Triple Negative Breast Cancer, run by Hoffmann-La Roche at 247 sites in 40 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody and Nab-Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
902 participants
Where
247 sitesin 40 countries
Study dates
23 Jun 2015to 31 Aug 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
  • No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
  • Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)
  • A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with Medical Monitor
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Measurable disease as defined by RECIST v1.1
  • Adequate hematologic and end-organ function

Who cannot join

  • Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
  • Leptomeningeal disease
  • Pregnancy or lactation
  • History of autoimmune disease
  • Prior allogeneic stem cell or solid organ transplantation
  • Positive test for human immunodeficiency virus
  • Active hepatitis B or hepatitis C
  • Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during treatment, or within 5 months following the last dose of atezolizumab/placebo

Trial locations and contacts

247 sites in 40 countries.

247 sites in 40 countries

United States49 sites

  • Kaiser Permanente Of Colorado

    Aurora, Colorado, 80014

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

  • St. Luke's Cancer Care Associates

    Bethlehem, Pennsylvania, 18015

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Wellmont Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • Rush University Medical Center - Chicago

    Chicago, Illinois, 60612

  • Onc/Hem Care Clin Trials LLC

    Cincinnati, Ohio, 45242

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

    Columbus, Ohio, 43219

  • Barbara Ann Karmanos Cancer Institute; Oncology

    Detroit, Michigan, 48201

  • Texas Oncology- El Paso Cancer Treatment Center Gateway

    El Paso, Texas, 79915

  • Inova Medical Group

    Fairfax, Virginia, 22031

  • Florida Cancer Specialists - SCRI; Pharmacy

    Fort Myers, Florida, 33901

  • West Clinic

    Germantown, Tennessee, 38138

  • Greenville Health System (GHS) Cancer Institute

    Greenville, South Carolina, 29605

  • The Methodist Cancer Center

    Houston, Texas, 77030

  • University of Texas;M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Jackson Oncology Associates, PLLC

    Jackson, Mississippi, 39202

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

    Jacksonville, Florida, 32256

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

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

    Kansas City, Missouri, 64132

  • ProHEALTH Care Associates LLP

    Lake Success, New York, 11042

  • New Hampshire Hematology Oncology

    Manchester, New Hampshire, 03103

  • Northwest Georgia Oncology Centers PC - Marietta

    Marietta, Georgia, 30060

  • The Mount Siani Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

    Nashville, Tennessee, 37203

  • Vanderbilt

    Nashville, Tennessee, 37232

  • Yale Cancer Center; Medical Oncology

    New Haven, Connecticut, 06520

  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

    New York, New York, 10016

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Kaiser Permanente of Northern California

    Oakland, California, 94612

  • Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Florida Cancer Research Institute

    Plantation, Florida, 33324

  • Kaiser Perm NW - Rheuma

    Portland, Oregon, 97227

  • Providence Cancer Center

    Portland, Oregon, 97231

  • Emad Ibrahim, Md, Inc

    Redlands, California, 92373

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Maryland Oncology Hematology

    Rochville, Maryland, 20850

  • Univ of Calif, San Francisco; Breast Cancer Center

    San Francisco, California, 94115

  • Kaiser Permanente - San Marcos

    San Marcos, California, 92069

  • Cancer Research Collaboration, Inc.

    Santa Ana, California, 92705

  • Cancer Care Northwest

    Spokane, Washington, 99204

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

  • Washington University School of Medicine

    St Louis, Missouri, 63110

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

    St. Petersburg, Florida, 33705

  • Stamford Hospital; BCC, MOHR

    Stamford, Connecticut, 06904

  • Stanford Univ School of Med; Oncology

    Stanford, California, 94305-5821

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)

    Washington D.C., District of Columbia, 20007

Other trials in United States

Japan27 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Gunma Prefectural Cancer Center

    Gunma, 373-8550

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • National Hospital Organization Hokkaido Cancer Center

    Hokkaido, 003-0804

  • Hyogo Medical University Hospital

    Hyōgo, 663-8501

  • Sagara Hospital

    Kagoshima, 892-0833

  • St. Marianna University Hospital

    Kanagawa, 216-8511

  • Tokai University Hospital

    Kanagawa, 259-1193

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Mie University Hospital

    Mie, 514-8507

  • Tohoku University Hospital

    Miyagi, 980-8574

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Okayama University Hospital

    Okayama, 700-8558

  • Naha-nishi Clinic

    Okinawa, 901-0154

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Kindai University Hospital

    Osaka, 589-8511

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

  • Saitama Cancer Center

    Saitama, 362-0806

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • St. Luke's International Hospital

    Tokyo, 104-8560

  • Komagome Hospital

    Tokyo, 113-8677

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

Other trials in Japan

Germany20 sites

  • Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters

    Berlin, 13581

  • St. Elisabeth-Krankenhaus; Brustzentrum

    Cologne, 50935

  • St. Johannes Hospital; Abt. für Hämatologie und Onkologie

    Dortmund, 44137

  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

    Dresden, 01307

  • Universitätsklinikum Erlangen; Frauenklinik

    Erlangen, 91054

  • Uniklinik Essen; Gynäkologie

    Essen, 45122

  • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

    Georgsmarienhütte, 49124

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

    Halle, 06120

  • Universitätsklinikum Hamburg-Eppendorf; Frauenklinik

    Hamburg, 20246

  • Facharztzentrum Eppendorf, Studien GbR

    Hamburg, 20249

  • Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

    Heidelberg, 69120

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

    Koblenz, 56068

  • Universitätsklinikum Schleswig-Holstein; Campus Lübeck

    Lübeck, 23538

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

    München, 81675

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Münster, 48153

  • MVZ Nordhausen gGmbH, Praxis Dr. Grafe

    Nordhausen, 99734

  • Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

    Recklinghausen, 45659

  • Mutterhaus der Borromäerinnen gGmbH, Abteilung Hämatologie-Onkologie

    Trier, 54290

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

    Troisdorf, 53840

  • Universitätsklinik Tübingen; Frauenklinik & Poliklinik

    Tübingen, 72076

Other trials in Germany

France12 sites

  • Ico - Paul Papin

    Angers, 49000

  • Institut Sainte Catherine

    Avignon, 84082

  • Hopital Jean Minjoz

    Besançon, 25030

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

    Grenoble, 38043

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69008

  • Institut régional du Cancer Montpellier

    Montpellier, 34298

  • Clinique Catherine de Sienne

    Nantes, 44202

  • Institut Curie

    Paris, 75005

  • Hopital La Pitie Salpetriere

    Paris, 75013

  • Institut De Cancerologie De L'Ouest; Medical Oncology

    Saint-Herblain, 44115

  • Centre Paul Strauss

    Strasbourg, 67000

Other trials in France

Canada11 sites

  • Tom Baker Cancer Centre-Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute ; Dept of Medical Oncology

    Edmonton, Alberta, T6G 1Z2

  • Queen Elizabeth II Health Sciences Centre; Oncology

    Halifax, Nova Scotia, B3H 2Y9

  • BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)

    Kelowna, British Columbia, V1Y 5L3

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Lakeridge Health Oshawa; Oncology

    Oshawa, Ontario, L1G 2B9

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K2H 6C2

  • Hopital du Saint Sacrement

    Québec, Quebec, G1S 4L8

  • Sunnybrook Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

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

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Brazil10 sites

  • Centro de Pesquisas Oncologicas - CEPON

    Florianópolis, Santa Catarina, 88034-000

  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336-550

  • Hospital Araujo Jorge; Departamento de Ginecologia E Mama

    Goiânia, Goiás, 74605-070

  • Hospital de Caridade de Ijui; Oncologia

    Ijuí, Rio Grande do Sul, 98700-000

  • Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301-220

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Santa Casa de Misericordia de Salvador

    Salvador, Estado de Bahia, 40050-410

  • Hospital Perola Byington

    São Paulo, São Paulo, 01317-000

  • Hospital Sao Jose

    São Paulo, São Paulo, 01321-001

Other trials in Brazil

United Kingdom10 sites

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • Western General Hospital; Clinical Oncology

    Edinburgh, EH4 2XU

  • St Bartholomew's Hospital

    London, EC1M 6BQ

  • Guys ST Thomas Hospital

    London, SE1 9RT

  • Royal Marsden Hospital - London

    London, SW3 6JJ

  • Christie Hospital Nhs Trust; Medical Oncology

    Manchester, M2O 4BX

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Royal Preston Hosptial

    Preston, PR2 9HT

  • Weston Park Hospital

    Sheffield, S10 2SJ

  • Royal Marsden Hospital; Dept of Medical Oncology

    Sutton, SM2 5PT

Other trials in United Kingdom

Australia8 sites

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Peninsula and South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199

  • Peter MacCallum Cancer Centre; Medical Oncology

    Melbourne, Victoria, 3000

  • Icon Cancer Foundation

    South Brisbane, Queensland, 4101

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • St John of God Hospital; Bendat Cancer Centre

    Subiaco, Western Australia, 6008

  • Nepean Cancer Care Centre

    Sydney, New South Wales, 2747

  • Princess Alexandra Hospital; Division of Cancer Services

    Woolloongabba, Queensland, 4102

Other trials in Australia

Spain8 sites

  • Hospital del Mar; Servicio de Oncologia

    Barcelona, 08003

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

  • Hospital Duran i Reynals; Oncologia

    Barcelona, 08907

  • Hospital Universitario Reina Sofia; Servicio de Oncologia

    Córdoba, Cordoba, 14004

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046

  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

    Málaga, 29010

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009

Other trials in Spain

Russia7 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, Arhangelsk, 163045

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan

    Kazan', 420029

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423

  • Main Military Clinical Hospital named after N.N. Burdenko

    Moscow, Moscow Oblast, 105229

  • Blokhin Cancer Research Center; Combined Treatment

    Moskva, Moscow Oblast, 115478

  • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

    Saint Petersburg, 197758

Other trials in Russia

Belgium6 sites

  • Institut Jules Bordet

    Anderlecht, 1070

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • GHdC Site Notre Dame

    Charleroi, 6000

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • Sint Augustinus Wilrijk

    Wilrijk, 2610

Other trials in Belgium

Poland6 sites

  • Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii

    Bydgoszcz, 85-796

  • Szpitale Wojewodzkie w Gdyni Sp. z o.o.

    Gdynia, 81-519

  • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

    Krakow, 30-688

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

    Lublin, 20-090

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

    Warsaw, 02-781

  • Wojskowy Instytut Medyczny

    Warsaw, 04-141

Other trials in Poland

Greece5 sites

  • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

    Athens, 115 22

  • IASO General Hospital of Athens

    Athens, 155 62

  • Univ General Hosp Heraklion; Medical Oncology

    Heraklion, 711 10

  • University Hospital of Patras Medical Oncology

    Pátrai, 265 04

  • Euromedical General Clinic of Thessaloniki; Oncology Department

    Thessaloniki, 546450

Other trials in Greece

Mexico5 sites

  • Instituto Estatal de Cancerologia Colima

    Colima, 28000

  • Iem-Fucam

    D.F., 04980

  • Centro Medico Dalinde

    Mexico City, Mexico CITY (federal District), 06760

  • Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

    Mexico City, 03100

  • Centro Médico Zambrano Hellion

    Monterrey, Nuevo León, 66278

Other trials in Mexico

South Korea5 sites

  • National Cancer Center

    Goyang-si, 10408

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Turkey (Türkiye)5 sites

  • Cukurova Uni Faculty of Medicine; Medical Oncology

    Adana, 01330

  • Istanbul University Cerrahpasa Medical Faculty; Radiation Oncology Department

    Istanbul, 34098

  • Medipol University MF; Oncology Department

    Istanbul, 34214

  • Ege Uni Medical Faculty Hospital; Oncology Dept

    Izmir, 35100

  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept

    Sihhiye/Ankara, 06230

Other trials in Turkey (Türkiye)

Austria4 sites

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

    Graz, 8036

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

    Linz, 4010

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

    Steyr, 4400

  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

    Vienna, 1090

Other trials in Austria

Taiwan4 sites

  • Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

    Kaohsiung City, 807

  • China Medical University Hospital; Surgery

    Taichung, 404

  • VETERANS GENERAL HOSPITAL; Department of General Surgery

    Taipei, 00112

  • National Taiwan Uni Hospital; General Surgery

    Taipei, 100

Other trials in Taiwan

Ukraine4 sites

  • Chemotherapy SI Dnipropetrovsk MA of MOHU

    Dnipropetrovsk, 49102

  • Kyiv City Clinical Oncological Center

    Kyiv, 03115

  • Treatment and Prevention Institution Volyn Regional Oncology Dispensary

    Lutsk, 43018

  • Lviv State Oncology Regional Treatment and Diagnostic Centre

    Lviv, 79031

Other trials in Ukraine

Argentina3 sites

  • Centro de Oncologia e Investigacion Buenos Aires (COIBA)

    Buenos Aires, B1884BBF

  • Fundación CENIT para la Investigación en Neurociencias

    Buenos Aires, C1125ABD

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

Other trials in Argentina

Czechia3 sites

  • Fakultni nemocnice Olomouc; Onkologicka klinika

    Olomouc, 779 00

  • Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

    Prague, 128 08

  • Fakultni nemocnice v Motole

    Prague, 150 06

Other trials in Czechia

Hungary3 sites

  • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

    Budapest, 1122

  • Fövárosi Önkormányzat uzsoki utcai Kórház

    Budapest, 1145

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6720

Other trials in Hungary

Norway3 sites

  • Helse Bergen HF Haukeland universitetssjukehus kreftavdelingen poliklinikk

    Bergen

  • Sørlandet Sykehus Kristiansand

    Kristiansand, 4604

  • Stavanger Universitetssykehus, Helse Stavanger HF

    Stavanger, 4011

Other trials in Norway

Switzerland3 sites

  • Universitaetsspital Basel; Onkologie

    Basel, 4031

  • Kantonsspital St.Gallen Brustzentrum/Chirurgie; Brustzentrum

    Sankt Gallen, 9007

  • Universitätsspital Zürich

    Zurich, 8038

Other trials in Switzerland

Thailand3 sites

  • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

    Bangkok, 10400

  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

    Bangkok, 10700

  • Songklanagarind Hospital; Department of Oncology

    Songkhla, 90110

Other trials in Thailand

Chile2 sites

  • Centro de Cancer Pontificie Universidad Catolica de Chile

    Santiago, 8330074

  • Sociedad de Investigaciones Medicas Ltda (SIM)

    Temuco, 4810469

Other trials in Chile

Colombia2 sites

  • Clinica del Country

    Bogotá, 11001

  • Oncomedica S.A.

    Montería, 230002

Other trials in Colombia

Costa Rica2 sites

  • Clinica CIMCA

    San José, 10103

  • ICIMED Instituto de Investigación en Ciencias Médicas

    San José, 10108

Other trials in Costa Rica

Estonia2 sites

  • North Estonia Medical Centre Foundation; Oncology Centre

    Tallinn, 13419

  • Tartu Uni Hospital; Hematology - Oncology Clinic

    Tartu, 51014

Other trials in Estonia

Italy2 sites

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

    Milan, Lombardy, 20141

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

    Naples, Campania, 80131

Other trials in Italy

Latvia2 sites

  • Daugavpils Regional Hospital

    Daugavpils, 5417

  • Riga East Clinical University Hospital Latvian Oncology Centre

    Riga, LV-1079

Other trials in Latvia

Singapore2 sites

  • National University Hospital

    Singapore, 119074

  • National Cancer Centre

    Singapore, 169610

Other trials in Singapore

Sweden2 sites

  • Sodersjukhuset; Onkologkliniken

    Stockholm, 118 83

  • Akademiska sjukhuset, Onkologkliniken

    Uppsala, 751 85

Other trials in Sweden

Bosnia and Herzegovina1 site

  • Clinic of Oncology, University Clinical Center Sarajevo

    Sarajevo, 7100

Other trials in Bosnia and Herzegovina

Finland1 site

  • Tampere University Hospital; Dept of Oncology

    Tampere, 33520

Other trials in Finland

Guatemala1 site

  • Grupo Angeles

    Guatemala City, 01015

Other trials in Guatemala

Hong Kong1 site

  • Queen Mary Hospital; Dept of Medicine

    Hong Kong

Other trials in Hong Kong

Panama1 site

  • Centro Oncológico de Panamá

    Panama City, 0801

Other trials in Panama

Romania1 site

  • Oncomed SRL

    Timișoara, 300239

Other trials in Romania

Slovenia1 site

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer

This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.

Being tested
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Nab-Paclitaxel, Placebo
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibodyDrug

    Also called Tecentriq, MPDL3280A

    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.

  • Nab-PaclitaxelDrug

    Also called Abraxane®

    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.

  • PlaceboDrug

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

Study groups in NCT02425891
Study groupRoleWhat they receive
Atezolizumab Plus Nab-PaclitaxelExperimentalParticipants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Receives: Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody; Drug: Nab-Paclitaxel
Placebo Plus Nab-PaclitaxelPlacebo comparatorParticipants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Receives: Drug: Nab-Paclitaxel; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants

    PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.

    Measured: Baseline up to approximately 34 months

  2. PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1)

    PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.

    Measured: Baseline up to approximately 34 months

  3. Overall Survival (OS) in All Randomized Participants

    OS was defined as the time from the date of randomization to the date of death from any cause.

    Measured: Baseline until death due to any cause (up to approximately 58 months)

  4. OS in Participants With Detectable PD-L1

    OS was defined as the time from the date of randomization to the date of death from any cause.

    Measured: Baseline until death due to any cause (up to approximately 58 months)

Secondary outcomes (11)

  1. Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants

    An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.

    Measured: Baseline up to approximately 34 months

  2. Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1

    An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.

    Measured: Baseline up to approximately 34 months

  3. Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants

    DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first.

    Measured: Baseline up to approximately 34 months

  4. DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1

    DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first.

    Measured: Baseline up to approximately 34 months

  5. Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants

    Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participant's GHS/HRQoL scale score showed a >=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of >= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of >= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.

    Measured: Baseline up to approximately 58 months

  6. TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1

    Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participants's GHS/HRQoL scale score showed a >=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of >= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of >= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.

    Measured: Baseline up to approximately 58 months

  7. Percentage of Participants With at Least One Adverse Event

    Percentage of participants with at least one adverse event.

    Measured: Baseline up to to the data cutoff date: 31 August 2021 (up to approximately 74 months)

  8. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab

    Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab

    Measured: Baseline up to approximately 53 months

  9. Maximum Serum Concentration (Cmax) for Atezolizumab

    Maximum serum concentration for atezolizumab.

    Measured: Cycle 1 Day 1 (Cycle = 28 days)

  10. Minimum Serum Concentration (Cmin) for Atezolizumab

    Minimum serum concentration for atezolizumab.

    Measured: Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days)

  11. Plasma Concentrations of Total Paclitaxel

    Plasma Concentrations of Total Paclitaxel

    Measured: Pre-dose (Hour 0) on Cycle 1 Day 1, pre-dose (Hour 0), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after end of nab-paclitaxel infusion (infusion duration = 30 minutes) on Cycle 3 Day 1 (Cycle = 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2015 (estimated)
  2. Study start23 Jun 2015
  3. Primary completion14 Apr 2020
  4. Study completion31 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
902 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02425891
Sponsor's protocol ID
WO29522
Other IDs
2014-005490-37, 2014
Status last verified
Jun 2022
First submitted
21 Apr 2015
Last updated
19 Jul 2022

Publications

  • Li M, Yang B. Prognostic Value of NUSAP1 and Its Correlation with Immune Infiltrates in Human Breast Cancer. Crit Rev Eukaryot Gene Expr. 2022;32(3):45-60. doi: 10.1615/CritRevEukaryotGeneExpr.2021040248.

    PubMed 35695609

  • Wang H, Ma H, Sove RJ, Emens LA, Popel AS. Quantitative systems pharmacology model predictions for efficacy of atezolizumab and nab-paclitaxel in triple-negative breast cancer. J Immunother Cancer. 2021 Feb;9(2):e002100. doi: 10.1136/jitc-2020-002100.

    PubMed 33579739

  • Adams S, Dieras V, Barrios CH, Winer EP, Schneeweiss A, Iwata H, Loi S, Patel S, Henschel V, Chui SY, Rugo HS, Emens LA, Schmid P. Patient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer. Ann Oncol. 2020 May;31(5):582-589. doi: 10.1016/j.annonc.2020.02.003. Epub 2020 Feb 20.

    PubMed 32178964

  • Schmid P, Rugo HS, Adams S, Schneeweiss A, Barrios CH, Iwata H, Dieras V, Henschel V, Molinero L, Chui SY, Maiya V, Husain A, Winer EP, Loi S, Emens LA; IMpassion130 Investigators. Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jan;21(1):44-59. doi: 10.1016/S1470-2045(19)30689-8. Epub 2019 Nov 27.

    PubMed 31786121

  • Schmid P, Adams S, Rugo HS, Schneeweiss A, Barrios CH, Iwata H, Dieras V, Hegg R, Im SA, Shaw Wright G, Henschel V, Molinero L, Chui SY, Funke R, Husain A, Winer EP, Loi S, Emens LA; IMpassion130 Trial Investigators. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2018 Nov 29;379(22):2108-2121. doi: 10.1056/NEJMoa1809615. Epub 2018 Oct 20.

    PubMed 30345906

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody and Nab-Paclitaxel in people with Triple Negative Breast Cancer, run by Hoffmann-La Roche at 247 sites in 40 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 247 sites in United States, Japan, Germany, France, Canada and 35 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants (time frame: Baseline up to approximately 34 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02425891, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in