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 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
2 other identifiers
interventional
902
37 countries
239
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2015
Longer than P75 for phase_3
239 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2015
CompletedFirst Posted
Study publicly available on registry
April 24, 2015
CompletedStudy Start
First participant enrolled
June 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2020
CompletedResults Posted
Study results publicly available
May 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedJuly 19, 2022
June 1, 2022
4.8 years
April 21, 2015
March 24, 2021
June 28, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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.
Baseline up to approximately 34 months
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.
Baseline up to approximately 34 months
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.
Baseline until death due to any cause (up to approximately 58 months)
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.
Baseline until death due to any cause (up to approximately 58 months)
Secondary Outcomes (11)
Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants
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
Baseline up to approximately 34 months
Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants
Baseline up to approximately 34 months
DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1
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
Baseline up to approximately 58 months
- +6 more secondary outcomes
Study Arms (2)
Atezolizumab Plus Nab-Paclitaxel
EXPERIMENTALParticipants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Placebo Plus Nab-Paclitaxel
PLACEBO COMPARATORParticipants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
Interventions
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 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 administered via IV infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (247)
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
Kaiser Permanente of Northern California
Oakland, California, 94612, United States
Emad Ibrahim, Md, Inc
Redlands, California, 92373, United States
Univ of Calif, San Francisco; Breast Cancer Center
San Francisco, California, 94115, United States
Kaiser Permanente - San Marcos
San Marcos, California, 92069, United States
Cancer Research Collaboration, Inc.
Santa Ana, California, 92705, United States
Stanford Univ School of Med; Oncology
Stanford, California, 94305-5821, United States
Kaiser Permanente Of Colorado
Aurora, Colorado, 80014, United States
Yale Cancer Center; Medical Oncology
New Haven, Connecticut, 06520, United States
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Stamford Hospital; BCC, MOHR
Stamford, Connecticut, 06904, United States
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
Washington D.C., District of Columbia, 20007, United States
Florida Cancer Specialists - SCRI; Pharmacy
Fort Myers, Florida, 33901, United States
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
Jacksonville, Florida, 32256, United States
The Mount Siani Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Florida Cancer Research Institute
Plantation, Florida, 33324, United States
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
St. Petersburg, Florida, 33705, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, 30060, United States
Rush University Medical Center - Chicago
Chicago, Illinois, 60612, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287, United States
Maryland Oncology Hematology
Rochville, Maryland, 20850, United States
Barbara Ann Karmanos Cancer Institute; Oncology
Detroit, Michigan, 48201, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202, United States
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
Kansas City, Missouri, 64132, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
New Hampshire Hematology Oncology
Manchester, New Hampshire, 03103, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
ProHEALTH Care Associates LLP
Lake Success, New York, 11042, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York, New York, 10016, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Onc/Hem Care Clin Trials LLC
Cincinnati, Ohio, 45242, United States
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
Columbus, Ohio, 43219, United States
Kaiser Perm NW - Rheuma
Portland, Oregon, 97227, United States
Providence Cancer Center
Portland, Oregon, 97231, United States
St. Luke's Cancer Care Associates
Bethlehem, Pennsylvania, 18015, United States
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
Greenville Health System (GHS) Cancer Institute
Greenville, South Carolina, 29605, United States
Wellmont Bristol Regional Medical Center
Bristol, Tennessee, 37620, United States
West Clinic
Germantown, Tennessee, 38138, United States
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville, Tennessee, 37203, United States
Vanderbilt
Nashville, Tennessee, 37232, United States
Texas Oncology- El Paso Cancer Treatment Center Gateway
El Paso, Texas, 79915, United States
The Methodist Cancer Center
Houston, Texas, 77030, United States
University of Texas;M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Inova Medical Group
Fairfax, Virginia, 22031, United States
Cancer Care Northwest
Spokane, Washington, 99204, United States
Centro de Oncologia e Investigacion Buenos Aires (COIBA)
Buenos Aires, B1884BBF, Argentina
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, C1125ABD, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300COE, Argentina
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Nepean Cancer Care Centre
Sydney, New South Wales, 2747, Australia
Icon Cancer Foundation
South Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital; Division of Cancer Services
Woolloongabba, Queensland, 4102, Australia
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199, Australia
Peter MacCallum Cancer Centre; Medical Oncology
Melbourne, Victoria, 3000, Australia
Sunshine Hospital
St Albans, Victoria, 3021, Australia
St John of God Hospital; Bendat Cancer Centre
Subiaco, Western Australia, 6008, Australia
Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
Graz, 8036, Austria
Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
Linz, 4010, Austria
A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie
Steyr, 4400, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
Vienna, 1090, Austria
Institut Jules Bordet
Anderlecht, 1070, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
GHdC Site Notre Dame
Charleroi, 6000, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Sint Augustinus Wilrijk
Wilrijk, 2610, Belgium
Clinic of Oncology, University Clinical Center Sarajevo
Sarajevo, 7100, Bosnia and Herzegovina
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336-550, Brazil
Santa Casa de Misericordia de Salvador
Salvador, Estado de Bahia, 40050-410, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiânia, Goiás, 74605-070, Brazil
Hospital de Caridade de Ijui; Oncologia
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Centro de Pesquisas Oncologicas - CEPON
Florianópolis, Santa Catarina, 88034-000, Brazil
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301-220, Brazil
Hospital Perola Byington
São Paulo, São Paulo, 01317-000, Brazil
Hospital Sao Jose
São Paulo, São Paulo, 01321-001, Brazil
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, T6G 1Z2, Canada
BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)
Kelowna, British Columbia, V1Y 5L3, Canada
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax, Nova Scotia, B3H 2Y9, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, L1G 2B9, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K2H 6C2, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Hopital du Saint Sacrement
Québec, Quebec, G1S 4L8, Canada
Centro de Cancer Pontificie Universidad Catolica de Chile
Santiago, 8330074, Chile
Sociedad de Investigaciones Medicas Ltda (SIM)
Temuco, 4810469, Chile
Clinica del Country
Bogotá, 11001, Colombia
Oncomedica S.A.
Montería, 230002, Colombia
Clinica CIMCA
San José, 10103, Costa Rica
ICIMED Instituto de Investigación en Ciencias Médicas
San José, 10108, Costa Rica
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, 779 00, Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Prague, 128 08, Czechia
Fakultni nemocnice v Motole
Prague, 150 06, Czechia
North Estonia Medical Centre Foundation; Oncology Centre
Tallinn, 13419, Estonia
Tartu Uni Hospital; Hematology - Oncology Clinic
Tartu, 51014, Estonia
Tampere University Hospital; Dept of Oncology
Tampere, 33520, Finland
Ico - Paul Papin
Angers, 49000, France
Institut Sainte Catherine
Avignon, 84082, France
Hopital Jean Minjoz
Besançon, 25030, France
HOPITAL MICHALLON - CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE, Service d'oncologie Médicale
Grenoble, 38043, France
Centre Oscar Lambret
Lille, 59020, France
Centre Leon Berard
Lyon, 69008, France
Institut régional du Cancer Montpellier
Montpellier, 34298, France
Clinique Catherine de Sienne
Nantes, 44202, France
Institut Curie
Paris, 75005, France
Hopital La Pitie Salpetriere
Paris, 75013, France
Institut De Cancerologie De L'Ouest; Medical Oncology
Saint-Herblain, 44115, France
Centre Paul Strauss
Strasbourg, 67000, France
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
Berlin, 13581, Germany
St. Elisabeth-Krankenhaus; Brustzentrum
Cologne, 50935, Germany
St. Johannes Hospital; Abt. für Hämatologie und Onkologie
Dortmund, 44137, Germany
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, 01307, Germany
Universitätsklinikum Erlangen; Frauenklinik
Erlangen, 91054, Germany
Uniklinik Essen; Gynäkologie
Essen, 45122, Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
Georgsmarienhütte, 49124, Germany
Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
Halle, 06120, Germany
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
Hamburg, 20246, Germany
Facharztzentrum Eppendorf, Studien GbR
Hamburg, 20249, Germany
Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
Heidelberg, 69120, Germany
Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin
Koblenz, 56068, Germany
Universitätsklinikum Schleswig-Holstein; Campus Lübeck
Lübeck, 23538, Germany
Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde
München, 81675, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, 48153, Germany
MVZ Nordhausen gGmbH, Praxis Dr. Grafe
Nordhausen, 99734, Germany
Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
Recklinghausen, 45659, Germany
Mutterhaus der Borromäerinnen gGmbH, Abteilung Hämatologie-Onkologie
Trier, 54290, Germany
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
Troisdorf, 53840, Germany
Universitätsklinik Tübingen; Frauenklinik & Poliklinik
Tübingen, 72076, Germany
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
Athens, 115 22, Greece
IASO General Hospital of Athens
Athens, 155 62, Greece
Univ General Hosp Heraklion; Medical Oncology
Heraklion, 711 10, Greece
University Hospital of Patras Medical Oncology
Pátrai, 265 04, Greece
Euromedical General Clinic of Thessaloniki; Oncology Department
Thessaloniki, 546450, Greece
Grupo Angeles
Guatemala City, 01015, Guatemala
Queen Mary Hospital; Dept of Medicine
Hong Kong, Hong Kong
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest, 1122, Hungary
Fövárosi Önkormányzat uzsoki utcai Kórház
Budapest, 1145, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6720, Hungary
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
Napoli, Campania, 80131, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
Milan, Lombardy, 20141, Italy
Aichi Cancer Center Hospital
Aichi, 464-8681, Japan
Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
Gunma Prefectural Cancer Center
Gunma, 373-8550, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido, 003-0804, Japan
Hyogo Medical University Hospital
Hyōgo, 663-8501, Japan
Sagara Hospital
Kagoshima, 892-0833, Japan
St. Marianna University Hospital
Kanagawa, 216-8511, Japan
Tokai University Hospital
Kanagawa, 259-1193, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Mie University Hospital
Mie, 514-8507, Japan
Tohoku University Hospital
Miyagi, 980-8574, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Naha-nishi Clinic
Okinawa, 901-0154, Japan
National Hospital Organization Osaka National Hospital
Osaka, 540-0006, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Kindai University Hospital
Osaka, 589-8511, Japan
Saitama Medical University International Medical Center
Saitama, 350-1298, Japan
Saitama Cancer Center
Saitama, 362-0806, Japan
Shizuoka Cancer Center
Shizuoka, 411-8777, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
St. Luke's International Hospital
Tokyo, 104-8560, Japan
Komagome Hospital
Tokyo, 113-8677, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Daugavpils Regional Hospital
Daugavpils, 5417, Latvia
Riga East Clinical University Hospital Latvian Oncology Centre
Riga, LV-1079, Latvia
Centro Medico Dalinde
Mexico City, Mexico CITY (federal District), 06760, Mexico
Centro Médico Zambrano Hellion
Monterrey, Nuevo León, 66278, Mexico
Instituto Estatal de Cancerologia Colima
Colima, 28000, Mexico
Iem-Fucam
D.F., 04980, Mexico
Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
Mexico City, 03100, Mexico
Helse Bergen HF Haukeland universitetssjukehus kreftavdelingen poliklinikk
Bergen, Norway
Sørlandet Sykehus Kristiansand
Kristiansand, 4604, Norway
Stavanger Universitetssykehus, Helse Stavanger HF
Stavanger, 4011, Norway
Centro Oncológico de Panamá
Panama City, 0801, Panama
Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
Bydgoszcz, 85-796, Poland
Szpitale Wojewodzkie w Gdyni Sp. z o.o.
Gdynia, 81-519, Poland
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Krakow, 30-688, Poland
Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
Lublin, 20-090, Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
Warsaw, 02-781, Poland
Wojskowy Instytut Medyczny
Warsaw, 04-141, Poland
Oncomed SRL
Timișoara, 300239, Romania
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, Arhangelsk, 163045, Russia
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, 143423, Russia
Main Military Clinical Hospital named after N.N. Burdenko
Moscow, Moscow Oblast, 105229, Russia
Blokhin Cancer Research Center; Combined Treatment
Moskva, Moscow Oblast, 115478, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, 153040, Russia
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan', 420029, Russia
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint Petersburg, 197758, Russia
National University Hospital
Singapore, 119074, Singapore
National Cancer Centre
Singapore, 169610, Singapore
Institute of Oncology Ljubljana
Ljubljana, 1000, Slovenia
National Cancer Center
Goyang-si, 10408, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, 14004, Spain
Hospital del Mar; Servicio de Oncologia
Barcelona, 08003, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035, Spain
Hospital Duran i Reynals; Oncologia
Barcelona, 08907, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, 29010, Spain
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, 46009, Spain
Sodersjukhuset; Onkologkliniken
Stockholm, 118 83, Sweden
Akademiska sjukhuset, Onkologkliniken
Uppsala, 751 85, Sweden
Universitaetsspital Basel; Onkologie
Basel, 4031, Switzerland
Kantonsspital St.Gallen Brustzentrum/Chirurgie; Brustzentrum
Sankt Gallen, 9007, Switzerland
Universitätsspital Zürich
Zurich, 8038, Switzerland
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
Kaohsiung City, 807, Taiwan
China Medical University Hospital; Surgery
Taichung, 404, Taiwan
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei, 00112, Taiwan
National Taiwan Uni Hospital; General Surgery
Taipei, 100, Taiwan
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok, 10400, Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, 10700, Thailand
Songklanagarind Hospital; Department of Oncology
Songkhla, 90110, Thailand
Cukurova Uni Faculty of Medicine; Medical Oncology
Adana, 01330, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty; Radiation Oncology Department
Istanbul, 34098, Turkey (Türkiye)
Medipol University MF; Oncology Department
Istanbul, 34214, Turkey (Türkiye)
Ege Uni Medical Faculty Hospital; Oncology Dept
Izmir, 35100, Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sihhiye/Ankara, 06230, Turkey (Türkiye)
Chemotherapy SI Dnipropetrovsk MA of MOHU
Dnipropetrovsk, 49102, Ukraine
Kyiv City Clinical Oncological Center
Kyiv, 03115, Ukraine
Treatment and Prevention Institution Volyn Regional Oncology Dispensary
Lutsk, 43018, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Centre
Lviv, 79031, Ukraine
Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
Western General Hospital; Clinical Oncology
Edinburgh, EH4 2XU, United Kingdom
St Bartholomew's Hospital
London, EC1M 6BQ, United Kingdom
Guys ST Thomas Hospital
London, SE1 9RT, United Kingdom
Royal Marsden Hospital - London
London, SW3 6JJ, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester, M2O 4BX, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Royal Preston Hosptial
Preston, PR2 9HT, United Kingdom
Weston Park Hospital
Sheffield, S10 2SJ, United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, SM2 5PT, United Kingdom
Related Publications (5)
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.
PMID: 35695609DERIVEDWang 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.
PMID: 33579739DERIVEDAdams 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.
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PMID: 30345906DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2015
First Posted
April 24, 2015
Study Start
June 23, 2015
Primary Completion
April 14, 2020
Study Completion
August 31, 2021
Last Updated
July 19, 2022
Results First Posted
May 17, 2021
Record last verified: 2022-06