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)

June 28, 2022 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

902

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1125ABD
        • Fundación Cenit para la Investigación en Neurociencias
      • Buenos Aires, Argentina, B1884BBF
        • Centro de Oncologia e Investigacion Buenos Aires (COIBA)
      • La Rioja, Argentina, F5300COE
        • Centro Oncologico Riojano Integral (Cori)
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Sydney, New South Wales, Australia, 2747
        • Nepean Cancer Care Centre
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Icon Cancer Foundation
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital; Division of Cancer Services
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Peninsula and South Eastern Haematology and Oncology Group
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre; Medical Oncology
      • St Albans, Victoria, Australia, 3021
        • Sunshine Hospital
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • St John of God Hospital; Bendat Cancer Centre
  • Austria
      • Graz, Austria, 8036
        • Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
      • Linz, Austria, 4010
        • Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
      • Steyr, Austria, 4400
        • A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie
      • Wien, Austria, 1090
        • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
  • Belgium
      • Anderlecht, Belgium, 1070
        • Institut Jules Bordet
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • Charleroi, Belgium, 6000
        • GHdC Site Notre Dame
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
      • Wilrijk, Belgium, 2610
        • Sint Augustinus Wilrijk
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 7100
        • Clinic of Oncology, University Clinical Center Sarajevo
  • Brazil
    • BA
      • Salvador, BA, Brazil, 40050-410
        • Santa Casa de Misericordia de Salvador
    • CE
      • Fortaleza, CE, Brazil, 60336-550
        • Crio - Centro Regional Integrado de Oncologia
    • GO
      • Goiania, GO, Brazil, 74605-070
        • Hospital Araujo Jorge; Departamento de Ginecologia E Mama
    • RS
      • Ijui, RS, Brazil, 98700-000
        • Hospital de Caridade de Ijui; Oncologia
      • Porto Alegre, RS, Brazil, 90610-000
        • Hospital Sao Lucas - PUCRS
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital das Clinicas - UFRGS
    • SC
      • Florianopolis, SC, Brazil, 88034-000
        • Centro de Pesquisas Oncologicas - CEPON
      • Itajai, SC, Brazil, 88301-220
        • Clinica de Neoplasias Litoral
    • SP
      • Sao Paulo, SP, Brazil, 01321-001
        • Hospital Sao Jose
      • Sao Paulo, SP, Brazil, 01317-000
        • Hospital Perola Byington
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre-Calgary
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute ; Dept of Medical Oncology
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Sciences Centre; Oncology
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa; Oncology
      • Ottawa, Ontario, Canada, K2H 6C2
        • The Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Odette Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Quebec City, Quebec, Canada, G1S 4L8
        • Hopital du Saint Sacrement
  • Chile
      • Santiago, Chile, 8330074
        • Centro de Cancer Pontificie Universidad Catolica de Chile
      • Temuco, Chile, 4810469
        • Sociedad de Investigaciones Medicas Ltda (SIM)
  • Colombia
      • Bogota, Colombia, 11001
        • Clinica del Country
      • Monteria, Colombia, 230002
        • Oncomedica S.A.
  • Costa Rica
      • San José, Costa Rica, 10103
        • Clinica CIMCA
      • San José, Costa Rica, 10108
        • ICIMED Instituto de Investigación en Ciencias Médicas
  • Czechia
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc; Onkologicka klinika
      • Praha 2, Czechia, 128 08
        • Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
      • Praha 5, Czechia, 150 06
        • Fakultni nemocnice v Motole
  • Estonia
      • Tallinn, Estonia, 13419
        • North Estonia Medical Centre Foundation; Oncology Centre
      • Tartu, Estonia, 51014
        • Tartu Uni Hospital; Hematology - Oncology Clinic
  • Finland
      • Tampere, Finland, 33520
        • Tampere University Hospital; Dept of Oncology
  • France
      • Angers, France, 49000
        • ICO - Paul Papin
      • Avignon, France, 84082
        • Institut Sainte Catherine
      • Besancon, France, 25030
        • Hôpital Jean Minjoz
      • Grenoble, France, 38043
        • HOPITAL MICHALLON - CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE, Service d'oncologie Médicale
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69008
        • Centre Leon Berard
      • Montpellier, France, 34298
        • Institut Régional du Cancer Montpellier
      • Nantes, France, 44202
        • Clinique Catherine de Sienne
      • Paris, France, 75005
        • Institut Curie
      • Paris, France, 75013
        • Hôpital La Pitié Salpêtrière
      • Saint Herblain, France, 44115
        • Institut De Cancerologie De L'Ouest; Medical Oncology
      • Strasbourg, France, 67000
        • Centre Paul Strauss
  • Germany
      • Berlin, Germany, 13581
        • Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
      • Dortmund, Germany, 44137
        • St. Johannes Hospital; Abt. für Hämatologie und Onkologie
      • Dresden, Germany, 01307
        • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen; Frauenklinik
      • Essen, Germany, 45122
        • Uniklinik Essen; Gynäkologie
      • Georgsmarienhütte, Germany, 49124
        • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
      • Halle, Germany, 06120
        • Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
      • Hamburg, Germany, 20249
        • Facharztzentrum Eppendorf, Studien GbR
      • Heidelberg, Germany, 69120
        • Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
      • Koblenz, Germany, 56068
        • Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin
      • Köln, Germany, 50935
        • St. Elisabeth-Krankenhaus; Brustzentrum
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein; Campus Lübeck
      • München, Germany, 81675
        • Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde
      • Münster, Germany, 48153
        • Gemeinschaftspraxis für Hämatologie und Onkologie
      • Nordhausen, Germany, 99734
        • MVZ Nordhausen gGmbH, Praxis Dr. Grafe
      • Recklinghausen, Germany, 45659
        • Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
      • Trier, Germany, 54290
        • Mutterhaus der Borromäerinnen gGmbH, Abteilung Hämatologie-Onkologie
      • Troisdorf, Germany, 53840
        • Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
      • Tübingen, Germany, 72076
        • Universitätsklinik Tübingen; Frauenklinik & Poliklinik
  • Greece
      • Athens, Greece, 115 22
        • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
      • Athens, Greece, 155 62
        • IASO General Hospital of Athens
      • Heraklion, Greece, 711 10
        • Univ General Hosp Heraklion; Medical Oncology
      • Patras, Greece, 265 04
        • University Hospital of Patras Medical Oncology
      • Thessaloniki, Greece, 546450
        • Euromedical General Clinic of Thessaloniki; Oncology Department
  • Guatemala
      • Guatemala City, Guatemala, 01015
        • Grupo Angeles
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital; Dept of Medicine
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
      • Budapest, Hungary, 1145
        • Fövárosi Önkormányzat uzsoki utcai Kórház
      • Szeged, Hungary, 6720
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
    • Lombardia
      • Milano, Lombardia, Italy, 20141
        • Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
  • Japan
      • Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
      • Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital
      • Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
      • Hyogo, Japan, 663-8501
        • Hyogo Medical University Hospital
      • Kagoshima, Japan, 892-0833
        • Sagara Hospital
      • Kanagawa, Japan, 259-1193
        • Tokai University Hospital
      • Kanagawa, Japan, 216-8511
        • St. Marianna University Hospital
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital
      • Mie, Japan, 514-8507
        • Mie University Hospital
      • Miyagi, Japan, 980-8574
        • Tohoku University Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Okinawa, Japan, 901-0154
        • Naha-nishi Clinic
      • Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital
      • Osaka, Japan, 589-8511
        • Kindai University Hospital
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center
      • Saitama, Japan, 362-0806
        • Saitama Cancer Center
      • Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital Of JFCR
      • Tokyo, Japan, 104-8560
        • St. Luke's International Hospital
      • Tokyo, Japan, 113-8677
        • Komagome Hospital
  • Korea, Republic of
      • Goyang-si, Korea, Republic of, 10408
        • National Cancer Center
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
  • Latvia
      • Daugavpils, Latvia, 5417
        • Daugavpils Regional Hospital
      • Riga, Latvia, LV-1079
        • Riga East Clinical University Hospital Latvian Oncology Centre
  • Mexico
      • Colima, Mexico, 28000
        • Instituto Estatal de Cancerologia Colima
      • D.f., Mexico, 04980
        • Iem-Fucam
      • Mexico City, Mexico, 03100
        • Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
    • Mexico CITY (federal District)
      • Cdmx, Mexico CITY (federal District), Mexico, 06760
        • Centro Medico Dalinde
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 66278
        • Centro Medico Zambrano Hellion
  • Norway
      • Bergen, Norway
        • Helse Bergen HF Haukeland universitetssjukehus kreftavdelingen poliklinikk
      • Kristiansand, Norway, 4604
        • Sørlandet Sykehus Kristiansand
      • Stavanger, Norway, 4011
        • Stavanger Universitetssykehus, Helse Stavanger HF
  • Panama
      • Panama, Panama, 0801
        • Centro Oncológico de Panamá
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
      • Gdynia, Poland, 81-519
        • Szpitale Wojewodzkie w Gdyni Sp. z o.o.
      • Kraków, Poland, 30-688
        • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
      • Warszawa, Poland, 02-781
        • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
      • Warszawa, Poland, 04-141
        • Wojskowy Instytut Medyczny
  • Romania
      • Timisoara, Romania, 300239
        • Oncomed SRL
  • Russian Federation
      • Ivanovo, Russian Federation, 153040
        • Ivanovo regional oncology dispensary
      • Kazan, Russian Federation, 420029
        • Clinical Oncology Dispensary of Ministry of Health of Tatarstan
      • Saint-Petersburg, Russian Federation, 197758
        • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
    • Arhangelsk
      • Arkhangelsk, Arhangelsk, Russian Federation, 163045
        • Arkhangelsk Regional Clinical Oncology Dispensary
    • Moskovskaja Oblast
      • Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
        • Moscow City Oncology Hospital #62
      • Moscow, Moskovskaja Oblast, Russian Federation, 105229
        • Main Military Clinical Hospital named after N.N. Burdenko
      • Moskva, Moskovskaja Oblast, Russian Federation, 115478
        • Blokhin Cancer Research Center; Combined Treatment
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 169610
        • National Cancer Centre
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar; Servicio de Oncologia
      • Barcelona, Spain, 08035
        • Hospital Univ Vall d'Hebron; Servicio de Oncologia
      • Barcelona, Spain, 08907
        • Hospital Duran i Reynals; Oncologia
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre; Servicio de Oncologia
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz; Servicio de Oncologia
      • Malaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
      • Valencia, Spain, 46009
        • Instituto Valenciano Oncologia; Oncologia Medica
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Sweden
      • Stockholm, Sweden, 118 83
        • Sodersjukhuset; Onkologkliniken
      • Uppsala, Sweden, 751 85
        • Akademiska sjukhuset, Onkologkliniken
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitaetsspital Basel; Onkologie
      • St. Gallen, Switzerland, 9007
        • Kantonsspital St.Gallen Brustzentrum/Chirurgie; Brustzentrum
      • Zürich, Switzerland, 8038
        • UniversitätsSpital Zürich
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
      • Taichung, Taiwan, 404
        • China Medical University Hospital; Surgery
      • Taipei, Taiwan, 00112
        • VETERANS GENERAL HOSPITAL; Department of General Surgery
      • Taipei, Taiwan, 100
        • National Taiwan Uni Hospital; General Surgery
  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
      • Songkhla, Thailand, 90110
        • Songklanagarind Hospital; Department of Oncology
  • Turkey
      • Adana, Turkey, 01330
        • Cukurova Uni Faculty of Medicine; Medical Oncology
      • Istanbul, Turkey, 34098
        • Istanbul University Cerrahpasa Medical Faculty; Radiation Oncology Department
      • Istanbul, Turkey, 34214
        • Medipol University MF; Oncology Department
      • Izmir, Turkey, 35100
        • Ege Uni Medical Faculty Hospital; Oncology Dept
      • Sihhiye/Ankara, Turkey, 06230
        • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • Chemotherapy SI Dnipropetrovsk MA of MOHU
      • Kyiv, Ukraine, 03115
        • Kyiv City Clinical Oncological Center
      • Lutsk, Ukraine, 43018
        • Treatment and Prevention Institution Volyn Regional Oncology Dispensary
      • Lviv, Ukraine, 79031
        • Lviv State Oncology Regional Treatment and Diagnostic Centre
  • United Kingdom
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre Cancer Centre
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital; Clinical Oncology
      • London, United Kingdom, EC1M 6BQ
        • St Bartholomew's Hospital
      • London, United Kingdom, SE1 9RT
        • Guys St Thomas Hospital
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital - London
      • Manchester, United Kingdom, M2O 4BX
        • Christie Hospital Nhs Trust; Medical Oncology
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hosptial
      • Sheffield, United Kingdom, S10 2SJ
        • Weston Park Hospital
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital; Dept of Medical Oncology
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology Group
    • California
      • Oakland, California, United States, 94612
        • Kaiser Permanente of Northern California
      • Redlands, California, United States, 92373
        • Emad Ibrahim, MD, INC
      • San Francisco, California, United States, 94115
        • Univ of Calif, San Francisco; Breast Cancer Center
      • San Marcos, California, United States, 92069
        • Kaiser Permanente - San Marcos
      • Santa Ana, California, United States, 92705
        • Cancer Research Collaboration, Inc.
      • Stanford, California, United States, 94305-5821
        • Stanford Univ School of Med; Oncology
    • Colorado
      • Aurora, Colorado, United States, 80014
        • Kaiser Permanente of Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Cancer Center; Medical Oncology
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
      • Stamford, Connecticut, United States, 06904
        • Stamford Hospital; BCC, MOHR
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists - SCRI; Pharmacy
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
      • Miami Beach, Florida, United States, 33140
        • The Mount Siani Comprehensive Cancer Center
      • Plantation, Florida, United States, 33324
        • Florida Cancer Research Institute
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers PC - Marietta
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center - Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
      • Rochville, Maryland, United States, 20850
        • Maryland Oncology Hematology
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute; Oncology
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Jackson Oncology Associates, PLLC
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Hampshire
      • Manchester, New Hampshire, United States, 03103
        • New Hampshire Hematology Oncology
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Lake Success, New York, United States, 11042
        • ProHEALTH Care Associates LLP
      • New York, New York, United States, 10016
        • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Onc/Hem Care Clin Trials LLC
      • Columbus, Ohio, United States, 43219
        • The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Perm NW - Rheuma
      • Portland, Oregon, United States, 97231
        • Providence Cancer Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Cancer Care Associates
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Womens Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System (GHS) Cancer Institute
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Wellmont Bristol Regional Medical Center
      • Germantown, Tennessee, United States, 38138
        • West Clinic
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt
    • Texas
      • El Paso, Texas, United States, 79915
        • Texas Oncology- El Paso Cancer Treatment Center Gateway
      • Houston, Texas, United States, 77030
        • The Methodist Cancer Center
      • Houston, Texas, United States, 77030
        • University of Texas;M.D. Anderson Cancer Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Medical Group
    • Washington
      • Spokane, Washington, United States, 99204
        • Cancer Care Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atezolizumab Plus Nab-Paclitaxel
Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
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.
Other Names:
  • Tecentriq, MPDL3280A
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.
Other Names:
  • Abraxane®
Placebo Comparator: Placebo Plus Nab-Paclitaxel
Participants assigned to placebo plus nab-paclitaxel received both agents 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.
Other Names:
  • Abraxane®
Drug: Placebo
Placebo administered via IV infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Baseline up to approximately 34 months
PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1)
Time Frame: Baseline up to approximately 34 months
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.
Baseline up to approximately 34 months
Overall Survival (OS) in All Randomized Participants
Time Frame: Baseline until death due to any cause (up to approximately 58 months)
OS was defined as the time from the date of randomization to the date of death from any cause.
Baseline until death due to any cause (up to approximately 58 months)
OS in Participants With Detectable PD-L1
Time Frame: Baseline until death due to any cause (up to approximately 58 months)
OS was defined as the time from the date of randomization to the date of death from any cause.
Baseline until death due to any cause (up to approximately 58 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants
Time Frame: Baseline up to approximately 34 months
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.
Baseline up to approximately 34 months
Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1
Time Frame: Baseline up to approximately 34 months
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.
Baseline up to approximately 34 months
Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants
Time Frame: Baseline up to approximately 34 months
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.
Baseline up to approximately 34 months
DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1
Time Frame: Baseline up to approximately 34 months
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.
Baseline up to approximately 34 months
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
Time Frame: Baseline up to approximately 58 months
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.
Baseline up to approximately 58 months
TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1
Time Frame: Baseline up to approximately 58 months
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.
Baseline up to approximately 58 months
Percentage of Participants With at Least One Adverse Event
Time Frame: Baseline up to to the data cutoff date: 31 August 2021 (up to approximately 74 months)
Percentage of participants with at least one adverse event.
Baseline up to to the data cutoff date: 31 August 2021 (up to approximately 74 months)
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Time Frame: Baseline up to approximately 53 months
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Baseline up to approximately 53 months
Maximum Serum Concentration (Cmax) for Atezolizumab
Time Frame: Cycle 1 Day 1 (Cycle = 28 days)
Maximum serum concentration for atezolizumab.
Cycle 1 Day 1 (Cycle = 28 days)
Minimum Serum Concentration (Cmin) for Atezolizumab
Time Frame: Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days)
Minimum serum concentration for atezolizumab.
Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days)
Plasma Concentrations of Total Paclitaxel
Time Frame: 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)
Plasma Concentrations of Total Paclitaxel
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2015

Primary Completion (Actual)

April 14, 2020

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WO29522
  • 2014-005490-37 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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