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Brief Title: A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
Official Title: A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Study ID: NCT04546009
Brief Summary: This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Long Beach Memorial Medical Center, Fountain Valley, California, United States
Orange Coast Memorial Medical Center, Fountain Valley, California, United States
Kaiser Permanente - San Leandro Medical Center, San Leandro, California, United States
Stanford Univ Medical Center, Stanford, California, United States
Kaiser Permanente - Vallejo, Vallejo, California, United States
Kaiser Permanente - Walnut Creek, Walnut Creek, California, United States
University of Colorado, Aurora, Colorado, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
Florida Cancer Specialists - Fort Myers (Broadway), Fort Myers, Florida, United States
Memorial Regional Cancer Ctr, Hollywood, Florida, United States
University of Miami; Dept Sylvester Cancer Center, Miami, Florida, United States
SCRI Florida Cancer Specialists North; Research Office North Region., Saint Petersburg, Florida, United States
SCRI Florida Cancer Specialists PAN, Tallahassee, Florida, United States
Kaiser Permanente - Moanalua Medical Center, Honolulu, Hawaii, United States
Mercy Medical Center, Baltimore, Maryland, United States
Maryland Oncology Hematology; Maryland Oncology Hematology, PA, Silver Spring, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
HCA Midwest Division, Kansas City, Missouri, United States
Memorial Sloan Kettering Cancer Center Basking Ridge, Basking Ridge, New Jersey, United States
Astera Cancer Care East Brunswick, East Brunswick, New Jersey, United States
Memorial Sloan Kettering - Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center at Bergen, Montvale, New Jersey, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
MSKCC @ Commack, Commack, New York, United States
Memorial Sloan Kettering Cancer Center at Westchester, Harrison, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center at Nassau, Uniondale, New York, United States
The Cleveland Clinic Foundation, Cleveland, Ohio, United States
Providence Portland Medical Ctr, Portland, Oregon, United States
Roper St. Francis Healthcare, Charleston, South Carolina, United States
West Cancer Center, Germantown, Tennessee, United States
Sarah Cannon Research Institute / Tennessee Oncology, Nashville, Tennessee, United States
Harrington Cancer Center, Amarillo, Texas, United States
Texas Oncology - DFW, Dallas, Texas, United States
Texas Oncology, P.A. - Fort Worth, Fort Worth, Texas, United States
The Center for Cancer and Blood Disorders - Fort Worth, Fort Worth, Texas, United States
Baylor St. Luke's Medical Center, Houston, Texas, United States
Houston Methodist Hospital, Houston, Texas, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Northwest Medical Specialties, Tacoma, Washington, United States
University of Wisconsin, Madison, Wisconsin, United States
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires, , Argentina
Hospital Britanico, Ciudad Autonoma Bs As, , Argentina
Organización medica de Investi, Ciudad Autonoma Buenos Aires, , Argentina
Hospital de Onc Angel Roffo, Ciudad Autonoma Buenos Aires, , Argentina
Instituto de Oncología de Rosario, Rosario, , Argentina
Hospital Provincial del Centenario, Rosario, , Argentina
CEMER Centro Medico de Enfermedades Respiratorias, Vicente López, , Argentina
Calvary Mater Newcastle; Medical Oncology, Waratah, New South Wales, Australia
Mater Hospital Brisbane, South Brisbane, Queensland, Australia
Princess Alexandra Hospital; Division of Cancer Services, Woolloongabba, Queensland, Australia
Flinders Medical Centre; Medical Oncology, Bedford Park, South Australia, Australia
Peter MacCallum Cancer Centre-East Melbourne, Melbourne, Victoria, Australia
Sunshine Hospital, St Albans, Victoria, Australia
Fiona Stanley Hospital - Medical Oncology, Murdoch, Western Australia, Australia
Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU, Salzburg, , Austria
A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie, Steyr, , Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I, Wien, , Austria
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
Jessa Zkh (Campus Virga Jesse), Hasselt, , Belgium
Hospital Sao Rafael - HSR, Salvador, BA, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiania, GO, Brazil
Hospital do Cancer de Pernambuco - HCP, Recife, PE, Brazil
Santa Casa de Misericordia de Porto Alegre, Porto Alegre, RS, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil
Hospital de Base de Sao Jose do Rio Preto, Sao Jose do Rio Preto, SP, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, Sao Paulo, SP, Brazil
Beneficencia Portuguesa de Sao Paulo, São Paulo, SP, Brazil
Tom Baker Cancer Centre-Calgary, Calgary, Alberta, Canada
BC Cancer ? Surrey, Surrey, British Columbia, Canada
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
William Osler Health System Brampton Civic Hospital, Brampton, Ontario, Canada
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Universite de Montreal - Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada
Centre Hospitalier de l?Université de Montréal (CHUM), Montreal, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
McGill University Health Center, Montreal, Quebec, Canada
Hopital du Saint Sacrement, Quebec City, Quebec, Canada
Anyang Tumor Hosptial, Anyang City, , China
Affiliated Hospital of Hebei University; Department of medical oncology, Baoding, , China
Peking University People's Hospital, Beijing, , China
Beijing Cancer Hospital, Beijing, , China
the First Affiliated Hospital of Bengbu Medical College, Bengbu City, , China
The First Hospital of Jilin University, Changchun City, , China
Hunan Cancer Hospital, Changsha CITY, , China
Fujian Medical University Union Hospital, Fuzhou City, , China
Sun Yet-sen University Cancer Center, Guangzhou City, , China
Sun Yat-sen Memorial Hospital, Guangzhou, , China
Sir Run Run Shaw Hospital Zhejiang University, Hangzhou City, , China
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department, Hangzhou City, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Shandong Cancer Hospital, Jinan, , China
The Third Hospital of Nanchang, Nanchang City, , China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University), Nanjing City, , China
Guangxi Cancer Hospital of Guangxi Medical University, Nanning City, , China
Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai City, , China
Cancer Hospital of Shantou University Medical College, Shantou, , China
Shengjing Hospital of China Medical University, ShenYang, , China
Liaoning cancer Hospital & Institute, Shenyang, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, , China
Hubei Cancer Hospital, Wuhan, , China
The First Affiliated Hospital of Xian Jiao Tong University, Xi'an City, , China
Herlev Hospital; Afdeling for Kræftbehandling, Herlev, , Denmark
Sjællands Universitetshospital, Næstved; Onkologisk Afdeling, Naestved, , Denmark
Odense Universitetshospital, Onkologisk Afdeling R, Odense C, , Denmark
ICO Paul Papin; Oncologie Medicale., Angers, , France
Centre Hospitalier de La Cote Basque; Oncologie, Bayonne, , France
CHD DE VENDEE; Unité de Recherche Clinique Onco-Hematologie, La Roche Sur Yon, , France
Institut régional du Cancer Montpellier, Montpellier, , France
Chu La Miletrie; Oncologie Medicale, Poitiers, , France
Institut Jean Godinot; Oncologie Medicale, Reims CEDEX, , France
Centre Eugene Marquis; Service d'oncologie, Rennes, , France
ICL; Hematologie, Saint-Priest en Jarez, , France
Centre Alexis Vautrin; Oncologie Medicale, Vandoeuvre-les-nancy, , France
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters, Berlin, , Germany
Klinikum Chemnitz gGmbH; Frauen- und Kinderklinik, Chemnitz, , Germany
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden, Dresden, , Germany
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde, Essen, , Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH, Georgsmarienhütte, , Germany
Dres.Andreas Ammon und Dirk Meyer, Göttingen, , Germany
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik, Hamburg, , Germany
Facharztzentrum Eppendorf, Studien GbR, Hamburg, , Germany
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie, Hannover, , Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg, Heidelberg, , Germany
Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin, Koblenz, , Germany
Dres. Andreas Köhler und Roswitha Fuchs, Langen, , Germany
St. Elisabeth-Krankenhaus, Senologie/Brustzentrum, Leipzig, , Germany
Universitätsklinikum Mannheim; Frauenklinik, Mannheim, , Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt, München, , Germany
Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg, Ravensburg, , Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie, Trier, , Germany
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis, Troisdorf, , Germany
Universitätsklinik Tübingen; Frauenklinik, Tübingen, , Germany
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine, Athens, , Greece
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine, Athens, , Greece
University Hospital of Larissa;Department of Medical Oncology, Larissa, , Greece
Euromedical General Clinic of Thessaloniki; Oncology Department, Thessaloniki, , Greece
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology, Hong Kong, , Hong Kong
Princess Margaret Hospital; Oncology, Hong Kong, , Hong Kong
Queen Mary Hospital; Dept of Medicine, Hong Kong, , Hong Kong
Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department, Budapest, , Hungary
Budapesti Uzsoki Utcai Kórház; Onkoradiológiai Osztály, Budapest, , Hungary
Davidof Center - Rabin Medical Center, Petah Tiqwa, , Israel
Chaim Sheba Medical Center; Oncology Dept, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Ctr; Oncology, Tel Aviv, , Israel
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola, Emilia-Romagna, Italy
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B, Roma, Lazio, Italy
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina, Brescia, Lombardia, Italy
Istituto Europeo Di Oncologia, Milano, Lombardia, Italy
ASST DI MONZA; Oncologia Medica, Monza, Lombardia, Italy
Fondazione del Piemonte per l?Oncologia (IRCCS), Candiolo, Piemonte, Italy
Humanitas Centro Catanese Di Oncologia; Oncologia Medica, Misterbianco (CT), Sicilia, Italy
Ospedale Civile - Livorno, Livorno, Toscana, Italy
Ospedale Sacro Cuore Don Calabria, Negrar, Veneto, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padova, Veneto, Italy
Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza, Vicenza, Veneto, Italy
Nagoya University Hospital, Aichi, , Japan
Chiba Cancer Center, Chiba, , Japan
National Cancer Center Hospital East, Chiba, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Fukushima Medical University Hospital, Fukushima, , Japan
Hiroshima City Hiroshima Citizens Hospital, Hiroshima, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
National Hospital Organization Hokkaido Cancer Center, Hokkaido, , Japan
Hyogo Cancer Center, Hyogo, , Japan
University of Tsukuba Hospital, Ibaraki, , Japan
Sagara Hospital, Kagoshima, , Japan
St. Marianna University Hospital, Kanagawa, , Japan
Kanagawa Cancer Center, Kanagawa, , Japan
Tokai University Hospital, Kanagawa, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Naha-nishi Clinic, Okinawa, , Japan
National Hospital Organization Osaka National Hospital, Osaka, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Saitama Cancer Center, Saitama, , Japan
National Cancer Center Hospital, Tokyo, , Japan
St. Luke's Internat. Hospital, Breast Surgical Oncology, Tokyo, , Japan
Juntendo University Hospital, Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Showa University Hospital, Tokyo, , Japan
Chungbuk National University Hospital, Cheongju si, , Korea, Republic of
Kyungpook National University Medical Center, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Ulsan University Hosiptal, Ulsan, , Korea, Republic of
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, Jalisco, Mexico
Health Pharma Professional Research, Cdmx, Mexico CITY (federal District), Mexico
Centro Medico Dalinde, Cdmx, Mexico CITY (federal District), Mexico
Filios Alta Medicina, Monterrey, Nuevo LEON, Mexico
Centro de Investigacion Clinica de Oaxaca, Oaxaca de Juárez, Oaxaca, Mexico
Oncologico Potosino, San Luis Potosí, SAN LUIS Potosi, Mexico
Sociedad de Metabolismo y Corazón (SOMECO), Veracruz, , Mexico
Auckland City Hospital; Clinical Oncology, Auckland, , New Zealand
Instituto Nacional de Enfermedades Neoplasicas, Lima, , Peru
Instituto Peruano de Oncología y Radioterapia, Lima, , Peru
Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel, Lima, , Peru
Oncosalud Sac; Oncología, Lima, , Peru
Clinica Ricardo Palma, San Isidro, , Peru
Instituto Regional de Enfermedades Neoplasicas - IREN Norte, Trujillo, , Peru
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii, Gdansk, , Poland
Szpital Morski im. PCK; Poradnia Onkologiczna, Gdynia, , Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr, Warszawa, , Poland
IPO de Coimbra; Servico de Oncologia Medica, Coimbra, , Portugal
Hospital da Luz; Departamento de Oncologia Medica, Lisboa, , Portugal
Centro Hospitalar Lisboa Norte, Lisboa, , Portugal
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
Respublikanskiy Onkologicheskiy Dispanser, Saransk, Mordovija, Russian Federation
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM", Moskva, Moskovskaja Oblast, Russian Federation
Podolsk City Clinical Hospital; Hematology, Podolsk, Moskovskaja Oblast, Russian Federation
Ryazan Regional clinical oncology dispensary, Ryazan, Rjazan, Russian Federation
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology), Saint Petersburg, Sankt Petersburg, Russian Federation
Chelyabinsk region oncology dispensary, Chelyabinsk, , Russian Federation
Multidisciplinary clinic Reaviz, Samara, , Russian Federation
Regional Clinical Oncology Hospital, Yaroslavl, , Russian Federation
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia, Sabadell, Barcelona, Spain
Hospital de Donostia; Servicio de Oncologia Medica, San Sebastian, Guipuzcoa, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia, A Coruña, LA Coruña, Spain
Hospital Quiron de Madrid; Servicio de Oncologia, Pozuelo de Alarcon, Madrid, Spain
Hospital del Mar; Servicio de Oncologia, Barcelona, , Spain
Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica, Barcelona, , Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona, , Spain
Hospital Duran i Reynals; Oncologia, Barcelona, , Spain
Hospital Lucus Augusti; Servicio de Oncologia, Lugo, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia, Madrid, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico San Carlos; Servicio de Oncologia, Madrid, , Spain
HM Sanchinarro ? CIOCC; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Sevilla, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
China Medical University Hospital; Surgery, Taichung, , Taiwan
National Cheng Kung Uni Hospital; Dept of Hematology and Oncology, Tainan, , Taiwan
VETERANS GENERAL HOSPITAL; Department of General Surgery, Taipei, , Taiwan
National Taiwan Uni Hospital; Dept of Oncology, Taipei, , Taiwan
Mackay Memorial Hospital; Dept of Surgery, Taipei, , Taiwan
Chang Gung Memorial Hosipital at Linkou, Taoyuan City, , Taiwan
Chulalongkorn Hospital, Faculty of Medicine; Dept. of Medicine, Bangkok, , Thailand
Rajavithi Hospital; Division of Medical Oncology, Bangkok, , Thailand
Ramathibodi Hospital; Medicine/Oncology, Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hosp; Surgery/Oncology, Chang Mai, , Thailand
Songklanagarind Hospital; Department of Oncology, Songkhla, , Thailand
Adana Baskent University Hospital; Medical Oncology, Adana, , Turkey
Ankara Bilkent City Hospital, Ankara, , Turkey
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne, , Turkey
Medipol University Medical Faculty; Oncology Department, Istanbul, , Turkey
Katip Celebi University Ataturk Training and Research Hospital; Oncology, Izmir, , Turkey
Kocaeli University Faculty of Medicine; Medical oncology, Izmit, , Turkey
Medeniyet University Goztepe Training and Research Hospital., Kadiköy, , Turkey
Antalya Memorial Hastanesi; Onkoloji, Kepez, , Turkey
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department, Malatya, , Turkey
19 Mayis University Medical Faculty; Medical Oncology Department, Samsun, , Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sihhiye/Ankara, , Turkey
Municipal Institution City Clinical Hospital #4 of Dnipro City Council, Dnipropetrovsk, Katerynoslav Governorate, Ukraine
Uzhgorod Central City Clinical Hospital, Uzhhorod, Katerynoslav Governorate, Ukraine
SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU, Kharkiv, Kharkiv Governorate, Ukraine
Ivano-Frankivsk Regional Oncology Center, Ivano-Frankivsk, , Ukraine
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department, Kryvyi Rih, , Ukraine
Sumy Regional Clinical Onc Ctr, Sumy, , Ukraine
Royal Sussex County Hospital, Brighton, , United Kingdom
Leicester Royal Infirmary; Infectious Disease Unit, Leicester, , United Kingdom
University College London Hospital, London, , United Kingdom
Royal Free Hospital, London, , United Kingdom
Guys & St Thomas Hospital; Department of Oncology, London, , United Kingdom
Royal Marsden Hosp NHS Fnd; Breast Unit, London, , United Kingdom
Maidstone Hospital; Kent Oncology Centre, Maidstone, , United Kingdom
Peterborough City Hospital; Oncology Research Department 018, Peterborough, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit, Sutton, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR