Breast Cancer Clinical Trial

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)

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

902

Study ID:

NCT02425891

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 243 Locations for this study

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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, 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 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)
Saint 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
Saint Louis Missouri, 63110, United States
New Hampshire Hematology Oncology
Manchester New Hampshire, 03103, United States
The Valley Hospital
Ridgewood New Jersey, 07450, United States
Montefiore Medical Center
Bronx New York, 10467, 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
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 , B1884, Argentina
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires , C1125, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja , F5300, 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
Wien , 1090, Austria
Institut Jules Bordet
Anderlecht , 1070, Belgium
Cliniques Universitaires St-Luc
Bruxelles , 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
Santa Casa de Misericordia de Salvador
Salvador BA, 40050, Brazil
Crio - Centro Regional Integrado de Oncologia
Fortaleza CE, 60336, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiania GO, 74605, Brazil
Hospital de Caridade de Ijui; Oncologia
Ijui RS, 98700, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre RS, 90035, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre RS, 90610, Brazil
Centro de Pesquisas Oncologicas - CEPON
Florianopolis SC, 88034, Brazil
Clinica de Neoplasias Litoral
Itajai SC, 88301, Brazil
Hospital Perola Byington
Sao Paulo SP, 01317, Brazil
Hospital Sao Jose
Sao Paulo SP, 01321, Brazil
Tom Baker Cancer Centre-Calgary
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton Alberta, T6G 1, Canada
BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)
Kelowna British Columbia, V1Y 5, Canada
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
Vancouver British Columbia, V5Z 4, Canada
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax Nova Scotia, B3H 2, Canada
Kingston General Hospital
Kingston Ontario, K7L 2, Canada
Lakeridge Health Oshawa; Oncology
Oshawa Ontario, L1G 2, Canada
The Ottawa Hospital Cancer Centre
Ottawa Ontario, K2H 6, Canada
Sunnybrook Odette Cancer Centre
Toronto Ontario, M4N 3, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Hopital du Saint Sacrement
Quebec City Quebec, G1S 4, Canada
Centro de Cancer Pontificie Universidad Catolica de Chile
Santiago , 83300, Chile
Sociedad de Investigaciones Medicas Ltda (SIM)
Temuco , 48104, Chile
Clinica del Country
Bogota , 11001, Colombia
Oncomedica S.A.
Monteria , 23000, 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 0, Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Praha 2 , 128 0, Czechia
Fakultni nemocnice v Motole
Praha 5 , 150 0, 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
Besancon , 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. 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
St. Elisabeth-Krankenhaus; Brustzentrum
Köln , 50935, 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 2, Greece
IASO General Hospital of Athens
Athens , 155 6, Greece
Univ General Hosp Heraklion; Medical Oncology
Heraklion , 711 1, Greece
University Hospital of Patras Medical Oncology
Patras , 265 0, Greece
Euromedical General Clinic of Thessaloniki; Oncology Department
Thessaloniki , 54645, 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
Milano Lombardia, 20141, Italy
Aichi Cancer Center Hospital
Aichi , 464-8, Japan
Fukushima Medical University Hospital
Fukushima , 960-1, Japan
Gunma Prefectural Cancer Center
Gunma , 373-8, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima , 730-8, Japan
Hiroshima University Hospital
Hiroshima , 734-8, Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido , 003-0, Japan
Hyogo Medical University Hospital
Hyogo , 663-8, Japan
Sagara Hospital
Kagoshima , 892-0, Japan
St. Marianna University Hospital
Kanagawa , 216-8, Japan
Tokai University Hospital
Kanagawa , 259-1, Japan
Kumamoto University Hospital
Kumamoto , 860-8, Japan
Kyoto University Hospital
Kyoto , 606-8, Japan
Mie University Hospital
Mie , 514-8, Japan
Tohoku University Hospital
Miyagi , 980-8, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Okayama University Hospital
Okayama , 700-8, Japan
Naha-nishi Clinic
Okinawa , 901-0, Japan
National Hospital Organization Osaka National Hospital
Osaka , 540-0, Japan
Osaka International Cancer Institute
Osaka , 541-8, Japan
Kindai University Hospital
Osaka , 589-8, Japan
Saitama Medical University International Medical Center
Saitama , 350-1, Japan
Saitama Cancer Center
Saitama , 362-0, Japan
Shizuoka Cancer Center
Shizuoka , 411-8, Japan
National Cancer Center Hospital
Tokyo , 104-0, Japan
St. Luke's International Hospital
Tokyo , 104-8, Japan
Komagome Hospital
Tokyo , 113-8, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Daugavpils Regional Hospital
Daugavpils , 5417, Latvia
Riga East Clinical University Hospital Latvian Oncology Centre
Riga , LV-10, Latvia
Centro Medico Dalinde
Cdmx Mexico CITY (federal District), 06760, Mexico
Centro Médico Zambrano Hellion
Monterrey Nuevo LEON, 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 , 0801, Panama
Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
Bydgoszcz , 85-79, Poland
Szpitale Wojewodzkie w Gdyni Sp. z o.o.
Gdynia , 81-51, Poland
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Kraków , 30-68, Poland
Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
Lublin , 20-09, Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
Warszawa , 02-78, Poland
Wojskowy Instytut Medyczny
Warszawa , 04-14, Poland
Oncomed SRL
Timisoara , 30023, Romania
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk Arhangelsk, 16304, Russian Federation
Moscow City Oncology Hospital #62
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Main Military Clinical Hospital named after N.N. Burdenko
Moscow Moskovskaja Oblast, 10522, Russian Federation
Blokhin Cancer Research Center; Combined Treatment
Moskva Moskovskaja Oblast, 11547, Russian Federation
Ivanovo Regional Oncology Dispensary
Ivanovo , 15304, Russian Federation
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan , 42002, Russian Federation
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint-Petersburg , 19775, Russian Federation
National University Hospital
Singapore , 11907, Singapore
National Cancer Centre
Singapore , 16961, Singapore
Institute of Oncology Ljubljana
Ljubljana , 1000, Slovenia
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
Malaga , 29010, Spain
Instituto Valenciano Oncologia; Oncologia Medica
Valencia , 46009, Spain
Sodersjukhuset; Onkologkliniken
Stockholm , 118 8, Sweden
Akademiska sjukhuset, Onkologkliniken
Uppsala , 751 8, Sweden
Universitaetsspital Basel; Onkologie
Basel , 4031, Switzerland
Kantonsspital St.Gallen Brustzentrum/Chirurgie; Brustzentrum
St. Gallen , 9007, Switzerland
Universitätsspital Zürich
Zürich , 8038, Switzerland
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
Kaohsiung , 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
Istanbul University Cerrahpasa Medical Faculty; Radiation Oncology Department
Istanbul , 34098, Turkey
Medipol University MF; Oncology Department
Istanbul , 34214, Turkey
Ege Uni Medical Faculty Hospital; Oncology Dept
Izmir , 35100, Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sihhiye/Ankara , 06230, Turkey
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 , United Kingdom
Western General Hospital; Clinical Oncology
Edinburgh , EH4 2, United Kingdom
St Bartholomew's Hospital
London , EC1M , United Kingdom
Guys ST Thomas Hospital
London , SE1 9, United Kingdom
Royal Marsden Hospital - London
London , SW3 6, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester , M2O 4, United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom
Royal Preston Hosptial
Preston , PR2 9, United Kingdom
Weston Park Hospital
Sheffield , S10 2, United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

902

Study ID:

NCT02425891

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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