Clinical trial NCT02425891: A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)
Official title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Triple Negative Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-04-24
Enrollment: 902
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants
timeFrame: Baseline up to approximately 34 months
measure: PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1)
timeFrame: Baseline up to approximately 34 months
measure: Overall Survival (OS) in All Randomized Participants
timeFrame: Baseline until death due to any cause (up to approximately 58 months)
measure: OS in Participants With Detectable PD-L1
timeFrame: Baseline until death due to any cause (up to approximately 58 months)
Secondary outcomes:
measure: Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants
timeFrame: Baseline up to approximately 34 months
measure: Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1
timeFrame: Baseline up to approximately 34 months
measure: Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants
timeFrame: Baseline up to approximately 34 months
measure: DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1
timeFrame: Baseline up to approximately 34 months
measure: 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
timeFrame: Baseline up to approximately 58 months
measure: TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1
timeFrame: Baseline up to approximately 58 months
measure: Percentage of Participants With at Least One Adverse Event
timeFrame: Baseline up to to the data cutoff date: 31 August 2021 (up to approximately 74 months)
measure: Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
timeFrame: Baseline up to approximately 53 months
measure: Maximum Serum Concentration (Cmax) for Atezolizumab
timeFrame: Cycle 1 Day 1 (Cycle = 28 days)
measure: Minimum Serum Concentration (Cmin) for Atezolizumab
timeFrame: Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days)
measure: Plasma Concentrations of Total Paclitaxel
timeFrame: 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)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Oakland
country: United States
facility: Kaiser Permanente of Northern California
state: California
city: Redlands
country: United States
facility: Emad Ibrahim, Md, Inc
state: California
city: San Francisco
country: United States
facility: Univ of Calif, San Francisco; Breast Cancer Center
state: California
city: San Marcos
country: United States
facility: Kaiser Permanente - San Marcos
state: California
city: Santa Ana
country: United States
facility: Cancer Research Collaboration, Inc.
state: California
city: Stanford
country: United States
facility: Stanford Univ School of Med; Oncology
state: California
city: Aurora
country: United States
facility: Kaiser Permanente Of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center; Medical Oncology
state: Connecticut
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Stamford
country: United States
facility: Stamford Hospital; BCC, MOHR
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
state: District of Columbia
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - SCRI; Pharmacy
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
state: Florida
city: Miami Beach
country: United States
facility: The Mount Siani Comprehensive Cancer Center
state: Florida
city: Plantation
country: United States
facility: Florida Cancer Research Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers PC - Marietta
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center - Chicago
state: Illinois
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Rochville
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute; Oncology
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Jackson
country: United States
facility: Jackson Oncology Associates, PLLC
state: Mississippi
city: Kansas City
country: United States
facility: Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Manchester
country: United States
facility: New Hampshire Hematology Oncology
state: New Hampshire
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Lake Success
country: United States
facility: ProHEALTH Care Associates LLP
state: New York
city: New York
country: United States
facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
state: New York
city: Cincinnati
country: United States
facility: Onc/Hem Care Clin Trials LLC
state: Ohio
city: Columbus
country: United States
facility: The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
state: Ohio
city: Portland
country: United States
facility: Kaiser Perm NW - Rheuma
state: Oregon
city: Portland
country: United States
facility: Providence Cancer Center
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Cancer Care Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Womens Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Health System (GHS) Cancer Institute
state: South Carolina
city: Bristol
country: United States
facility: Wellmont Bristol Regional Medical Center
state: Tennessee
city: Germantown
country: United States
facility: West Clinic
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt
state: Tennessee
city: El Paso
country: United States
facility: Texas Oncology- El Paso Cancer Treatment Center Gateway
state: Texas
city: Houston
country: United States
facility: The Methodist Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Texas;M.D. Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Inova Medical Group
state: Virginia
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Buenos Aires
country: Argentina
facility: Centro de Oncologia e Investigacion Buenos Aires (COIBA)
city: Buenos Aires
country: Argentina
facility: Fundación CENIT para la Investigación en Neurociencias
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (CORI)
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Sydney
country: Australia
facility: Nepean Cancer Care Centre
state: New South Wales
city: South Brisbane
country: Australia
facility: Icon Cancer Foundation
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital; Division of Cancer Services
state: Queensland
city: Frankston
country: Australia
facility: Peninsula and South Eastern Haematology and Oncology Group
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre; Medical Oncology
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Subiaco
country: Australia
facility: St John of God Hospital; Bendat Cancer Centre
state: Western Australia
city: Graz
country: Austria
facility: Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
city: Linz
country: Austria
facility: Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
city: Steyr
country: Austria
facility: A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Charleroi
country: Belgium
facility: GHdC Site Notre Dame
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinic of Oncology, University Clinical Center Sarajevo
city: Salvador
country: Brazil
facility: Santa Casa de Misericordia de Salvador
state: BA
city: Fortaleza
country: Brazil
facility: Crio - Centro Regional Integrado de Oncologia
state: CE
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama
state: GO
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui; Oncologia
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Florianopolis
country: Brazil
facility: Centro de Pesquisas Oncologicas - CEPON
state: SC
city: Itajai
country: Brazil
facility: Clinica de Neoplasias Litoral
state: SC
city: Sao Paulo
country: Brazil
facility: Hospital Perola Byington
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Sao Jose
state: SP
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre-Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute ; Dept of Medical Oncology
state: Alberta
city: Kelowna
country: Canada
facility: BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre; Oncology
state: Nova Scotia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa; Oncology
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Quebec City
country: Canada
facility: Hopital du Saint Sacrement
state: Quebec
city: Santiago
country: Chile
facility: Centro de Cancer Pontificie Universidad Catolica de Chile
city: Temuco
country: Chile
facility: Sociedad de Investigaciones Medicas Ltda (SIM)
city: Bogota
country: Colombia
facility: Clinica del Country
city: Monteria
country: Colombia
facility: Oncomedica S.A.
city: San José
country: Costa Rica
facility: Clinica CIMCA
city: San José
country: Costa Rica
facility: ICIMED Instituto de Investigación en Ciencias Médicas
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc; Onkologicka klinika
city: Praha 2
country: Czechia
facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation; Oncology Centre
city: Tartu
country: Estonia
facility: Tartu Uni Hospital; Hematology - Oncology Clinic
city: Tampere
country: Finland
facility: Tampere University Hospital; Dept of Oncology
city: Angers
country: France
facility: Ico - Paul Papin
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Besancon
country: France
facility: Hopital Jean Minjoz
city: Grenoble
country: France
facility: HOPITAL MICHALLON - CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE, Service d'oncologie Médicale
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Montpellier
country: France
facility: Institut régional du Cancer Montpellier
city: Nantes
country: France
facility: Clinique Catherine de Sienne
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hopital La Pitie Salpetriere
city: Saint Herblain
country: France
facility: Institut De Cancerologie De L'Ouest; Medical Oncology
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Berlin
country: Germany
facility: Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
city: Dortmund
country: Germany
facility: St. Johannes Hospital; Abt. für Hämatologie und Onkologie
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen; Frauenklinik
city: Essen
country: Germany
facility: Uniklinik Essen; Gynäkologie
city: Georgsmarienhütte
country: Germany
facility: Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf, Studien GbR
city: Heidelberg
country: Germany
facility: Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
city: Koblenz
country: Germany
facility: Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin
city: Köln
country: Germany
facility: St. Elisabeth-Krankenhaus; Brustzentrum
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein; Campus Lübeck
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde
city: Münster
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
city: Nordhausen
country: Germany
facility: MVZ Nordhausen gGmbH, Praxis Dr. Grafe
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
city: Trier
country: Germany
facility: Mutterhaus der Borromäerinnen gGmbH, Abteilung Hämatologie-Onkologie
city: Troisdorf
country: Germany
facility: Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen; Frauenklinik & Poliklinik
city: Athens
country: Greece
facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
city: Athens
country: Greece
facility: IASO General Hospital of Athens
city: Heraklion
country: Greece
facility: Univ General Hosp Heraklion; Medical Oncology
city: Patras
country: Greece
facility: University Hospital of Patras Medical Oncology
city: Thessaloniki
country: Greece
facility: Euromedical General Clinic of Thessaloniki; Oncology Department
city: Guatemala City
country: Guatemala
facility: Grupo Angeles
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital; Dept of Medicine
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
city: Budapest
country: Hungary
facility: Fövárosi Önkormányzat uzsoki utcai Kórház
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
state: Campania
city: Milano
country: Italy
facility: Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
state: Lombardia
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Gunma
country: Japan
facility: Gunma Prefectural Cancer Center
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hokkaido
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
city: Hyogo
country: Japan
facility: Hyogo Medical University Hospital
city: Kagoshima
country: Japan
facility: Sagara Hospital
city: Kanagawa
country: Japan
facility: St. Marianna University Hospital
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Mie
country: Japan
facility: Mie University Hospital
city: Miyagi
country: Japan
facility: Tohoku University Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Okinawa
country: Japan
facility: Naha-nishi Clinic
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Osaka
country: Japan
facility: Kindai University Hospital
city: Saitama
country: Japan
facility: Saitama Medical University International Medical Center
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: St. Luke's International Hospital
city: Tokyo
country: Japan
facility: Komagome Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital Latvian Oncology Centre
city: Cdmx
country: Mexico
facility: Centro Medico Dalinde
state: Mexico CITY (federal District)
city: Monterrey
country: Mexico
facility: Centro Médico Zambrano Hellion
state: Nuevo LEON
city: Colima
country: Mexico
facility: Instituto Estatal de Cancerologia Colima
city: D.f.
country: Mexico
facility: Iem-Fucam
city: Mexico City
country: Mexico
facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
city: Bergen
country: Norway
facility: Helse Bergen HF Haukeland universitetssjukehus kreftavdelingen poliklinikk
city: Kristiansand
country: Norway
facility: Sørlandet Sykehus Kristiansand
city: Stavanger
country: Norway
facility: Stavanger Universitetssykehus, Helse Stavanger HF
city: Panama
country: Panama
facility: Centro Oncológico de Panamá
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
city: Gdynia
country: Poland
facility: Szpitale Wojewodzkie w Gdyni Sp. z o.o.
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
city: Warszawa
country: Poland
facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
city: Timisoara
country: Romania
facility: Oncomed SRL
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Oncology Dispensary
state: Arhangelsk
city: Moscovskaya Oblast
country: Russian Federation
facility: Moscow City Oncology Hospital #62
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: Main Military Clinical Hospital named after N.N. Burdenko
state: Moskovskaja Oblast
city: Moskva
country: Russian Federation
facility: Blokhin Cancer Research Center; Combined Treatment
state: Moskovskaja Oblast
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Kazan
country: Russian Federation
facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan
city: Saint-Petersburg
country: Russian Federation
facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Oncologia
state: Cordoba
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Duran i Reynals; Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologia; Oncologia Medica
city: Stockholm
country: Sweden
facility: Sodersjukhuset; Onkologkliniken
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset, Onkologkliniken
city: Basel
country: Switzerland
facility: Universitaetsspital Basel; Onkologie
city: St. Gallen
country: Switzerland
facility: Kantonsspital St.Gallen Brustzentrum/Chirurgie; Brustzentrum
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
city: Taichung
country: Taiwan
facility: China Medical University Hospital; Surgery
city: Taipei
country: Taiwan
facility: VETERANS GENERAL HOSPITAL; Department of General Surgery
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital; General Surgery
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
city: Bangkok
country: Thailand
facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital; Department of Oncology
city: Adana
country: Turkey
facility: Cukurova Uni Faculty of Medicine; Medical Oncology
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty; Radiation Oncology Department
city: Istanbul
country: Turkey
facility: Medipol University MF; Oncology Department
city: Izmir
country: Turkey
facility: Ege Uni Medical Faculty Hospital; Oncology Dept
city: Sihhiye/Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept
city: Dnipropetrovsk
country: Ukraine
facility: Chemotherapy SI Dnipropetrovsk MA of MOHU
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncological Center
city: Lutsk
country: Ukraine
facility: Treatment and Prevention Institution Volyn Regional Oncology Dispensary
city: Lviv
country: Ukraine
facility: Lviv State Oncology Regional Treatment and Diagnostic Centre
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: Edinburgh
country: United Kingdom
facility: Western General Hospital; Clinical Oncology
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: Guys ST Thomas Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital - London
city: Manchester
country: United Kingdom
facility: Christie Hospital Nhs Trust; Medical Oncology
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hosptial
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital; Dept of Medical Oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.