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)

NCT ID: NCT02425891

Last Updated: 2022-07-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

902 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-23

Study Completion Date

2021-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Triple Negative Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Atezolizumab Plus Nab-Paclitaxel

Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody

Intervention Type DRUG

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-Paclitaxel

Intervention Type DRUG

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.

Placebo Plus Nab-Paclitaxel

Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.

Group Type PLACEBO_COMPARATOR

Nab-Paclitaxel

Intervention Type DRUG

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.

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Tecentriq, MPDL3280A Abraxane®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Highlands Oncology Group

Springdale, Arkansas, United States

Site Status

Kaiser Permanente of Northern California

Oakland, California, United States

Site Status

Emad Ibrahim, Md, Inc

Redlands, California, United States

Site Status

Univ of Calif, San Francisco; Breast Cancer Center

San Francisco, California, United States

Site Status

Kaiser Permanente - San Marcos

San Marcos, California, United States

Site Status

Cancer Research Collaboration, Inc.

Santa Ana, California, United States

Site Status

Stanford Univ School of Med; Oncology

Stanford, California, United States

Site Status

Kaiser Permanente Of Colorado

Aurora, Colorado, United States

Site Status

Yale Cancer Center; Medical Oncology

New Haven, Connecticut, United States

Site Status

Norwalk Hospital

Norwalk, Connecticut, United States

Site Status

Stamford Hospital; BCC, MOHR

Stamford, Connecticut, United States

Site Status

MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)

Washington D.C., District of Columbia, United States

Site Status

Florida Cancer Specialists - SCRI; Pharmacy

Fort Myers, Florida, United States

Site Status

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

Jacksonville, Florida, United States

Site Status

The Mount Siani Comprehensive Cancer Center

Miami Beach, Florida, United States

Site Status

Florida Cancer Research Institute

Plantation, Florida, United States

Site Status

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

St. Petersburg, Florida, United States

Site Status

Northwest Georgia Oncology Centers PC - Marietta

Marietta, Georgia, United States

Site Status

Rush University Medical Center - Chicago

Chicago, Illinois, United States

Site Status

Mercy Medical Center

Baltimore, Maryland, United States

Site Status

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status

Maryland Oncology Hematology

Rochville, Maryland, United States

Site Status

Barbara Ann Karmanos Cancer Institute; Oncology

Detroit, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Jackson Oncology Associates, PLLC

Jackson, Mississippi, United States

Site Status

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

Kansas City, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

New Hampshire Hematology Oncology

Manchester, New Hampshire, United States

Site Status

The Valley Hospital

Ridgewood, New Jersey, United States

Site Status

ProHEALTH Care Associates LLP

Lake Success, New York, United States

Site Status

Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

New York, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Onc/Hem Care Clin Trials LLC

Cincinnati, Ohio, United States

Site Status

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

Columbus, Ohio, United States

Site Status

Kaiser Perm NW - Rheuma

Portland, Oregon, United States

Site Status

Providence Cancer Center

Portland, Oregon, United States

Site Status

St. Luke's Cancer Care Associates

Bethlehem, Pennsylvania, United States

Site Status

Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Greenville Health System (GHS) Cancer Institute

Greenville, South Carolina, United States

Site Status

Wellmont Bristol Regional Medical Center

Bristol, Tennessee, United States

Site Status

West Clinic

Germantown, Tennessee, United States

Site Status

Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

Nashville, Tennessee, United States

Site Status

Vanderbilt

Nashville, Tennessee, United States

Site Status

Texas Oncology- El Paso Cancer Treatment Center Gateway

El Paso, Texas, United States

Site Status

The Methodist Cancer Center

Houston, Texas, United States

Site Status

University of Texas;M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Inova Medical Group

Fairfax, Virginia, United States

Site Status

Cancer Care Northwest

Spokane, Washington, United States

Site Status

Centro de Oncologia e Investigacion Buenos Aires (COIBA)

Buenos Aires, , Argentina

Site Status

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, , Argentina

Site Status

Centro Oncologico Riojano Integral (CORI)

La Rioja, , Argentina

Site Status

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Site Status

Nepean Cancer Care Centre

Sydney, New South Wales, Australia

Site Status

Icon Cancer Foundation

South Brisbane, Queensland, Australia

Site Status

Princess Alexandra Hospital; Division of Cancer Services

Woolloongabba, Queensland, Australia

Site Status

Peninsula and South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

Site Status

Peter MacCallum Cancer Centre; Medical Oncology

Melbourne, Victoria, Australia

Site Status

Sunshine Hospital

St Albans, Victoria, Australia

Site Status

St John of God Hospital; Bendat Cancer Centre

Subiaco, Western Australia, Australia

Site Status

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

Graz, , Austria

Site Status

Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1

Linz, , Austria

Site Status

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

Steyr, , Austria

Site Status

Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

Vienna, , Austria

Site Status

Institut Jules Bordet

Anderlecht, , Belgium

Site Status

Cliniques Universitaires St-Luc

Brussels, , Belgium

Site Status

GHdC Site Notre Dame

Charleroi, , Belgium

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AZ Groeninge

Kortrijk, , Belgium

Site Status

UZ Leuven Gasthuisberg

Leuven, , Belgium

Site Status

Sint Augustinus Wilrijk

Wilrijk, , Belgium

Site Status

Clinic of Oncology, University Clinical Center Sarajevo

Sarajevo, , Bosnia and Herzegovina

Site Status

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Site Status

Santa Casa de Misericordia de Salvador

Salvador, Estado de Bahia, Brazil

Site Status

Hospital Araujo Jorge; Departamento de Ginecologia E Mama

Goiânia, Goiás, Brazil

Site Status

Hospital de Caridade de Ijui; Oncologia

Ijuí, Rio Grande do Sul, Brazil

Site Status

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Centro de Pesquisas Oncologicas - CEPON

Florianópolis, Santa Catarina, Brazil

Site Status

Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, Brazil

Site Status

Hospital Perola Byington

São Paulo, São Paulo, Brazil

Site Status

Hospital Sao Jose

São Paulo, São Paulo, Brazil

Site Status

Tom Baker Cancer Centre-Calgary

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute ; Dept of Medical Oncology

Edmonton, Alberta, Canada

Site Status

BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)

Kelowna, British Columbia, Canada

Site Status

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

Site Status

Queen Elizabeth II Health Sciences Centre; Oncology

Halifax, Nova Scotia, Canada

Site Status

Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Lakeridge Health Oshawa; Oncology

Oshawa, Ontario, Canada

Site Status

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

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Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada

Site Status

Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Hopital du Saint Sacrement

Québec, Quebec, Canada

Site Status

Centro de Cancer Pontificie Universidad Catolica de Chile

Santiago, , Chile

Site Status

Sociedad de Investigaciones Medicas Ltda (SIM)

Temuco, , Chile

Site Status

Clinica del Country

Bogotá, , Colombia

Site Status

Oncomedica S.A.

Montería, , Colombia

Site Status

Clinica CIMCA

San José, , Costa Rica

Site Status

ICIMED Instituto de Investigación en Ciencias Médicas

San José, , Costa Rica

Site Status

Fakultni nemocnice Olomouc; Onkologicka klinika

Olomouc, , Czechia

Site Status

Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

Prague, , Czechia

Site Status

Fakultni nemocnice v Motole

Prague, , Czechia

Site Status

North Estonia Medical Centre Foundation; Oncology Centre

Tallinn, , Estonia

Site Status

Tartu Uni Hospital; Hematology - Oncology Clinic

Tartu, , Estonia

Site Status

Tampere University Hospital; Dept of Oncology

Tampere, , Finland

Site Status

Ico - Paul Papin

Angers, , France

Site Status

Institut Sainte Catherine

Avignon, , France

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Hopital Jean Minjoz

Besançon, , France

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

Grenoble, , France

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Centre Oscar Lambret

Lille, , France

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Centre Leon Berard

Lyon, , France

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Institut régional du Cancer Montpellier

Montpellier, , France

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Clinique Catherine de Sienne

Nantes, , France

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Institut Curie

Paris, , France

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Hopital La Pitie Salpetriere

Paris, , France

Site Status

Institut De Cancerologie De L'Ouest; Medical Oncology

Saint-Herblain, , France

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Centre Paul Strauss

Strasbourg, , France

Site Status

Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters

Berlin, , Germany

Site Status

St. Elisabeth-Krankenhaus; Brustzentrum

Cologne, , Germany

Site Status

St. Johannes Hospital; Abt. für Hämatologie und Onkologie

Dortmund, , Germany

Site Status

Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

Dresden, , Germany

Site Status

Universitätsklinikum Erlangen; Frauenklinik

Erlangen, , Germany

Site Status

Uniklinik Essen; Gynäkologie

Essen, , Germany

Site Status

Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

Georgsmarienhütte, , Germany

Site Status

Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

Halle, , Germany

Site Status

Universitätsklinikum Hamburg-Eppendorf; Frauenklinik

Hamburg, , Germany

Site Status

Facharztzentrum Eppendorf, Studien GbR

Hamburg, , Germany

Site Status

Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

Heidelberg, , Germany

Site Status

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

Koblenz, , Germany

Site Status

Universitätsklinikum Schleswig-Holstein; Campus Lübeck

Lübeck, , Germany

Site Status

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

München, , Germany

Site Status

Gemeinschaftspraxis für Hämatologie und Onkologie

Münster, , Germany

Site Status

MVZ Nordhausen gGmbH, Praxis Dr. Grafe

Nordhausen, , Germany

Site Status

Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

Recklinghausen, , Germany

Site Status

Mutterhaus der Borromäerinnen gGmbH, Abteilung Hämatologie-Onkologie

Trier, , Germany

Site Status

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

Troisdorf, , Germany

Site Status

Universitätsklinik Tübingen; Frauenklinik & Poliklinik

Tübingen, , Germany

Site Status

Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

Athens, , Greece

Site Status

IASO General Hospital of Athens

Athens, , Greece

Site Status

Univ General Hosp Heraklion; Medical Oncology

Heraklion, , Greece

Site Status

University Hospital of Patras Medical Oncology

Pátrai, , Greece

Site Status

Euromedical General Clinic of Thessaloniki; Oncology Department

Thessaloniki, , Greece

Site Status

Grupo Angeles

Guatemala City, , Guatemala

Site Status

Queen Mary Hospital; Dept of Medicine

Hong Kong, , Hong Kong

Site Status

Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

Budapest, , Hungary

Site Status

Fövárosi Önkormányzat uzsoki utcai Kórház

Budapest, , Hungary

Site Status

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, , Hungary

Site Status

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

Napoli, Campania, Italy

Site Status

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

Milan, Lombardy, Italy

Site Status

Aichi Cancer Center Hospital

Aichi, , Japan

Site Status

Fukushima Medical University Hospital

Fukushima, , Japan

Site Status

Gunma Prefectural Cancer Center

Gunma, , Japan

Site Status

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, , Japan

Site Status

Hiroshima University Hospital

Hiroshima, , Japan

Site Status

National Hospital Organization Hokkaido Cancer Center

Hokkaido, , Japan

Site Status

Hyogo Medical University Hospital

Hyōgo, , Japan

Site Status

Sagara Hospital

Kagoshima, , Japan

Site Status

St. Marianna University Hospital

Kanagawa, , Japan

Site Status

Tokai University Hospital

Kanagawa, , Japan

Site Status

Kumamoto University Hospital

Kumamoto, , Japan

Site Status

Kyoto University Hospital

Kyoto, , Japan

Site Status

Mie University Hospital

Mie, , Japan

Site Status

Tohoku University Hospital

Miyagi, , Japan

Site Status

Niigata Cancer Center Hospital

Niigata, , Japan

Site Status

Okayama University Hospital

Okayama, , Japan

Site Status

Naha-nishi Clinic

Okinawa, , Japan

Site Status

National Hospital Organization Osaka National Hospital

Osaka, , Japan

Site Status

Osaka International Cancer Institute

Osaka, , Japan

Site Status

Kindai University Hospital

Osaka, , Japan

Site Status

Saitama Medical University International Medical Center

Saitama, , Japan

Site Status

Saitama Cancer Center

Saitama, , Japan

Site Status

Shizuoka Cancer Center

Shizuoka, , Japan

Site Status

National Cancer Center Hospital

Tokyo, , Japan

Site Status

St. Luke's International Hospital

Tokyo, , Japan

Site Status

Komagome Hospital

Tokyo, , Japan

Site Status

The Cancer Institute Hospital of JFCR

Tokyo, , Japan

Site Status

Daugavpils Regional Hospital

Daugavpils, , Latvia

Site Status

Riga East Clinical University Hospital Latvian Oncology Centre

Riga, , Latvia

Site Status

Centro Medico Dalinde

Mexico City, Mexico CITY (federal District), Mexico

Site Status

Centro Médico Zambrano Hellion

Monterrey, Nuevo León, Mexico

Site Status

Instituto Estatal de Cancerologia Colima

Colima, , Mexico

Site Status

Iem-Fucam

D.F., , Mexico

Site Status

Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

Mexico City, , Mexico

Site Status

Helse Bergen HF Haukeland universitetssjukehus kreftavdelingen poliklinikk

Bergen, , Norway

Site Status

Sørlandet Sykehus Kristiansand

Kristiansand, , Norway

Site Status

Stavanger Universitetssykehus, Helse Stavanger HF

Stavanger, , Norway

Site Status

Centro Oncológico de Panamá

Panama City, , Panama

Site Status

Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii

Bydgoszcz, , Poland

Site Status

Szpitale Wojewodzkie w Gdyni Sp. z o.o.

Gdynia, , Poland

Site Status

Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

Krakow, , Poland

Site Status

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

Lublin, , Poland

Site Status

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

Warsaw, , Poland

Site Status

Wojskowy Instytut Medyczny

Warsaw, , Poland

Site Status

Oncomed SRL

Timișoara, , Romania

Site Status

Arkhangelsk Regional Clinical Oncology Dispensary

Arkhangelsk, Arhangelsk, Russia

Site Status

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast, Russia

Site Status

Main Military Clinical Hospital named after N.N. Burdenko

Moscow, Moscow Oblast, Russia

Site Status

Blokhin Cancer Research Center; Combined Treatment

Moskva, Moscow Oblast, Russia

Site Status

Ivanovo Regional Oncology Dispensary

Ivanovo, , Russia

Site Status

Clinical Oncology Dispensary of Ministry of Health of Tatarstan

Kazan', , Russia

Site Status

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

Saint Petersburg, , Russia

Site Status

National University Hospital

Singapore, , Singapore

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National Cancer Centre

Singapore, , Singapore

Site Status

Institute of Oncology Ljubljana

Ljubljana, , Slovenia

Site Status

National Cancer Center

Goyang-si, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, Cordoba, Spain

Site Status

Hospital del Mar; Servicio de Oncologia

Barcelona, , Spain

Site Status

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, , Spain

Site Status

Hospital Duran i Reynals; Oncologia

Barcelona, , Spain

Site Status

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, , Spain

Site Status

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, , Spain

Site Status

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

Málaga, , Spain

Site Status

Instituto Valenciano Oncologia; Oncologia Medica

Valencia, , Spain

Site Status

Sodersjukhuset; Onkologkliniken

Stockholm, , Sweden

Site Status

Akademiska sjukhuset, Onkologkliniken

Uppsala, , Sweden

Site Status

Universitaetsspital Basel; Onkologie

Basel, , Switzerland

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Kantonsspital St.Gallen Brustzentrum/Chirurgie; Brustzentrum

Sankt Gallen, , Switzerland

Site Status

Universitätsspital Zürich

Zurich, , Switzerland

Site Status

Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital; Surgery

Taichung, , Taiwan

Site Status

VETERANS GENERAL HOSPITAL; Department of General Surgery

Taipei, , Taiwan

Site Status

National Taiwan Uni Hospital; General Surgery

Taipei, , Taiwan

Site Status

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

Bangkok, , Thailand

Site Status

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

Bangkok, , Thailand

Site Status

Songklanagarind Hospital; Department of Oncology

Songkhla, , Thailand

Site Status

Cukurova Uni Faculty of Medicine; Medical Oncology

Adana, , Turkey (Türkiye)

Site Status

Istanbul University Cerrahpasa Medical Faculty; Radiation Oncology Department

Istanbul, , Turkey (Türkiye)

Site Status

Medipol University MF; Oncology Department

Istanbul, , Turkey (Türkiye)

Site Status

Ege Uni Medical Faculty Hospital; Oncology Dept

Izmir, , Turkey (Türkiye)

Site Status

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sihhiye/Ankara, , Turkey (Türkiye)

Site Status

Chemotherapy SI Dnipropetrovsk MA of MOHU

Dnipropetrovsk, , Ukraine

Site Status

Kyiv City Clinical Oncological Center

Kyiv, , Ukraine

Site Status

Treatment and Prevention Institution Volyn Regional Oncology Dispensary

Lutsk, , Ukraine

Site Status

Lviv State Oncology Regional Treatment and Diagnostic Centre

Lviv, , Ukraine

Site Status

Velindre Cancer Centre

Cardiff, , United Kingdom

Site Status

Western General Hospital; Clinical Oncology

Edinburgh, , United Kingdom

Site Status

St Bartholomew's Hospital

London, , United Kingdom

Site Status

Guys ST Thomas Hospital

London, , United Kingdom

Site Status

Royal Marsden Hospital - London

London, , United Kingdom

Site Status

Christie Hospital Nhs Trust; Medical Oncology

Manchester, , United Kingdom

Site Status

Derriford Hospital

Plymouth, , United Kingdom

Site Status

Royal Preston Hosptial

Preston, , United Kingdom

Site Status

Weston Park Hospital

Sheffield, , United Kingdom

Site Status

Royal Marsden Hospital; Dept of Medical Oncology

Sutton, , United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Belgium Bosnia and Herzegovina Brazil Canada Chile Colombia Costa Rica Czechia Estonia Finland France Germany Greece Guatemala Hong Kong Hungary Italy Japan Latvia Mexico Norway Panama Poland Romania Russia Singapore Slovenia South Korea Spain Sweden Switzerland Taiwan Thailand Turkey (Türkiye) Ukraine United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35695609 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33579739 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32178964 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31786121 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30345906 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2014-005490-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WO29522

Identifier Type: -

Identifier Source: org_study_id

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