Spots Global Cancer Trial Database for A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
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Trial Identification
Brief Title: A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
Official Title: A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)
Study ID: NCT05132582
Conditions
Study Description
Brief Summary: This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.
Detailed Description: Control arm: Placebo given orally twice daily plus trastuzumab and pertuzumab every 21 days Experimental arm: Tucatinib 300 mg given orally twice daily plus trastuzumab and pertuzumab every 21 days Trastuzumab and pertuzumab will be administered as follows: • Trastuzumab will be given intravenously (IV) at a dose of 6 mg/kg or subcutaneously (SC) at a fixed dose of 600 mg, once every 21 days. AND * Pertuzumab will be given IV at 420 mg every 21 days. OR * Fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given SC, once every 21 days, in lieu of trastuzumab and pertuzumab individually.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Arizona, Phoenix, Arizona, United States
CARTI Cancer Center, Little Rock, Arkansas, United States
UC San Diego / Moores Cancer Center, La Jolla, California, United States
UCLA Department of Medicine - Hematology & Oncology, Santa Monica, California, United States
Lundquist Institute/Harbor-UCLA, Torrance, California, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
AdventHealth Cancer Institute, Orlando, Florida, United States
Orlando Health, Inc. TRIO, Orlando, Florida, United States
Winship Cancer Institute / Emory University School of Medicine, Atlanta, Georgia, United States
Kaiser Permanente Moanalua Medical Center, Honolulu, Hawaii, United States
University of Illinois at Chicago, Chicago, Illinois, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Mercy Medical Center -Weinberg Center, Baltimore, Maryland, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Saint Luke's Cancer Institute LLC, Kansas City, Missouri, United States
Nebraska Cancer Specialists, Grand Island, Nebraska, United States
Oncology Hematology West, P.C., Omaha, Nebraska, United States
Rutgers Cancer Institute of New Jersey, Jersey City, New Jersey, United States
Monmouth Medical Center Southern Campus, Lakewood, New Jersey, United States
Saint Barnabas Medical Center Cancer Center, Livingston, New Jersey, United States
Monmouth Medical Center, Long Branch, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
Robert Wood Johnson University Hospital Somerset, Somerville, New Jersey, United States
Community Medical Center, Toms River, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
Cleveland Clinic, The, Cleveland, Ohio, United States
Zangmeister Cancer Center, Columbus, Ohio, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Willow Grove, Pennsylvania, United States
Charleston Oncology, Charleston, South Carolina, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute, Nashville, Tennessee, United States
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington, Seattle, Washington, United States
Medical College of Wisconsin (Milwaukee), Milwaukee, Wisconsin, United States
Cancer Research South Australia, Adelaide, Other, Australia
Flinders Medical Centre, Bedford Park, Other, Australia
Box Hill Hospital, Box Hill, Other, Australia
Chris O'Brien Lifehouse, Camperdown, Other, Australia
Peninsula and South East Oncology, Frankston, Other, Australia
Austin Health, Heidelberg, Other, Australia
Macquarie University Hospital, Macquarie University, Other, Australia
St John of God Subiaco Hospital, Subiaco, Other, Australia
Westmead Hospital, Sydney, Other, Australia
LKH- Universitat Klinikum Graz, Graz, Other, Austria
Medizinische Universitat Innsbruck, Innsbruck, Other, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern, Linz, Other, Austria
Ordination Priv.-Doz. Dr. M. Hubalek, Schwaz, Other, Austria
AKH - Medizinische Universitat Wien, Vienna, Other, Austria
Institut Jules Bordet, Anderlecht, Other, Belgium
UCL Saint-Luc, Brussels, Other, Belgium
Universitair Ziekenhuis Brussel, Bruxelles-Capitale, Other, Belgium
Clinique Saint Pierre, Ottignies, Other, Belgium
GZA Hospital Sint-Augustinus, Wilrijk, Other, Belgium
Hospital de Cancer de Barretos - Fundacao Pio XII, Barretos, Other, Brazil
Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda., Bela Vista, Other, Brazil
INCAN - Instituto do Cancer - Hospital Pompeia, Caxias do Sul, Other, Brazil
Centro Regional Integrado de Oncologia, Fortaleza, Other, Brazil
Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias, Goiania, Other, Brazil
Fundacao Doutor Amaral Carvalho, Jaú, Other, Brazil
Hospital do Cancer de Londrina, Londrina, Other, Brazil
Liga Norte-Rio-Grandense Contra o Cancer, Natal, Other, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Other, Brazil
Hospital de Clinicas de Porto Alegre, Porto Alegre, Other, Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa, Porto Alegre, Other, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, Other, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo Andre, Other, Brazil
Praxis Pesquisa Medica, Santo Andre, Other, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto, Sao Jose Rio Preto, Other, Brazil
Fundacao Antonio Prudente (AC Camargo Cancer Center), Sao Paulo, Other, Brazil
Sao Camilo Oncologia, Sao Paulo, Other, Brazil
ICESP - Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira, São Paulo, Other, Brazil
University of Alberta / Cross Cancer Institute, Edmonton, Alberta, Canada
BC Cancer Kelowna, Kelowna, British Columbia, Canada
Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto, Toronto, Ontario, Canada
CIUSSS du Saguenay Lac Saint Jean, Chicoutimi, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Centro de Investigacion Clinica Bradford Hill, Santiago, Other, Chile
Pontificia Universidad Catolica De Chile Santiago, Santiago, Other, Chile
Clinica Universidad Catolica del Maule, Talca, Other, Chile
Sociedad de Investigaciones Medicas Limitada, Temuco, Other, Chile
Oncocentro APYS, Viña del Mar, Other, Chile
Affiliated Hospital of Hebei University, Baoding, Other, China
Beijing Hospital, Beijing, Other, China
The First Bethune Hospital of Jilin University, Changchun, Other, China
The Second Xiangya Hospital of Central South University, Changsha, Other, China
Affiliated Hospital of Chengde Medical University, Chengde, Other, China
The First People's Hospital of Foshan, Foshan, Other, China
Fujian Provincial Cancer Hospital, Fuzhou, Other, China
900TH Hospital of Joint Logistics Support Force, Fuzhou, Other, China
Guangdong Provincial People's Hospital, Guangzhou, Other, China
The first Affiliated Hospital of Hainan Medical University, Haikou, Other, China
Zhejiang Cancer Hospital, Hangzhou City, Other, China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Other, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Hangzhou, Other, China
Harbin Medical University Cancer Hospital, Harbin, Other, China
The Second Hospital of Anhui Medical University, Hefei, Other, China
The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Other, China
Jinan Central Hospital, Jinan, Other, China
Linyi Cancer Hospital, Linyi, Other, China
Liuzhou People's Hospital, Liuzhou, Other, China
Meizhou People's Hospital - Guangdong Province, Meizhou, Other, China
The Second Affiliated Hospital of Nanchang University, Nanchang, Other, China
Nanjing Medical University (NMU) - Jiangsu Province Hospital, Nanjing, Other, China
The First Affiliated Hospital of Guangxi Medical University, Nanning, Other, China
Nantong Tumor Hospital, Nantong, Other, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine, Shanghai, Other, China
Fudan University Shanghai Cancer Center, Shanghai, Other, China
The First Hospital of China Medical University, Shenyang, Other, China
Liaoning Cancer Hospital and Institute, Shenyang, Other, China
Tianjin Medical University - Cancer Institute & Hospital, Tianjin, Other, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan City, Other, China
Hubei Cancer Hospital, Wuhan, Other, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Other, China
Shaanxi Provincial People's Hospital, Xi'an, Other, China
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Other, China
The Affiliated Hospital of Xuzhou Medical College, Xuzhou, Other, China
Xuzhou Central Hospital, Xuzhou, Other, China
Yantai Yuhuangding Hospital, Yantai, Other, China
Henan Provincial People's Hospital, Zhengzhou, Other, China
Henan Cancer Hospital, Zhengzhou, Other, China
Nanchang Third Hospital, Nanchang City, , China
Guangxi Medical University Affiliated Tumor Hospital, Nanning, , China
Masaryk Memorial Cancer Institute, Brno, Other, Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, Other, Czechia
Thomayer University Hospital (Fakultní Thomayerova nemocnice), Praha 4-Krc, Other, Czechia
Fakultni nemocnice v Motole, Praha 5, Other, Czechia
Nemocnice Horovice (NH Hospital) a.s., Praha, Other, Czechia
Helsinki University Hospital, Helsinki, Other, Finland
Kuopio University Hospital, Kuopio, Other, Finland
Tampere University Hospital, Tampere, Pirkanmaa, Other, Finland
Vaasa Central Hospital, Vaasa, Other, Finland
Sainte Catherine Institut du Cancer Avignon Provence, Avignon, Other, France
Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz, Besancon Cedex, Other, France
Centre Hospitalier Universitaire Hopital Avicenne, Bobigny, Other, France
Institut Bergonie, Bordeaux, Other, France
Centre de Lutte contre le Cancer - Francois Baclesse, Caen Cedex 5, Other, France
Centre Jean Perrin, Clermont-Ferrand, Other, France
CARIO - Centre Armoricain De Radiothérapie, D'imagerie Médicale Et D'oncologie, Cotes d'Armor, Other, France
Center Georges Francois Leclerc, Dijon, Other, France
Centre de Lutte contre le Cancer (CLCC) - Centre Oscar Lambret, Lille, Other, France
Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren, Limoges Cedex, Other, France
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes, Lyon cedex 08, Other, France
Centre de Cancerologie du Grand Montpellier, Montpellier, Other, France
Institut Regional du Cancer de Montpellier, Montpellier, Other, France
Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne, Nice Cedex 2, Other, France
Hopitaux Civils de Lyon, Pierre Benite, Other, France
Centre Eugene Marquis, Rennes, Other, France
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer, Rouen, Other, France
Institut de Cancerologie de lOuest - Site Rene Gauducheau, Saint Herblain cedex, Other, France
Institut Curie, Saint-Cloude, Other, France
Institut de cancerologie Strasbourg Europe, Strasbourg, Other, France
Institut Curie, Paris, , France
Universitatsklinikum Augsburg, Augsburg, Other, Germany
Charite Universitatsmedizin Berlin, Berlin, Other, Germany
Universitaetsklinikum Dusseldorf, Dusseldorf, Other, Germany
Universitatsklinikum Erlangen, Erlangen, Other, Germany
Universitaetsklinikum Essen, Essen, Other, Germany
Klinikum Esslingen GmbH, Esslingen, Other, Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE), Hamburg, Other, Germany
Medizinische Hochschule Hannover, Hannover, Other, Germany
St. Elisabeth-Krankenhaus Koln-Hohenlind, Koln, Other, Germany
Universitatsklinikum Schleswig-Holstein - Campus Lubeck, Lubeck, Other, Germany
Medical Faculty Mannheim, Heidelberg University, Mannheim, Other, Germany
Klinikum Rechts der Isar der Technischen Universitaet Muenchen, München, Other, Germany
Universitaetsklinikum Muenster, Münster, Other, Germany
Universitatsklinik Tuebingen, Tubingen, Other, Germany
Universitatsklinikum Ulm, Ulm, Other, Germany
Uniklinikum Wurzburg, Wurzburg, Other, Germany
Krankenhaus St. Josef, Regensburg, , Germany
Alexandra General Hospital of Athens, Athens, Other, Greece
University Hospital Attikon, Haidari, Other, Greece
University General Hospital of Heraklion (PAGNI), Heraklion, Other, Greece
University Hospital of Larissa, Larissa, Other, Greece
Hygeia Hospital, Marousi, Other, Greece
IASO, Maroussi, Other, Greece
General Hospital of Thessaloniki Papageorgiou, Nea Efkarpia, Other, Greece
Metropolitan General Hospital, Neo Faliro, Other, Greece
University Hospital of Patras, Patras, Other, Greece
Metaxa Anticancer Hospital of Piraeus, Pireaus, Other, Greece
Euromedica General Clinic, Thessaloniki, Other, Greece
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi, Bologna, Other, Italy
Azienda Ospedaliero-Universitaria di Ferrara, Cona (FE), Other, Italy
Azienda Ospedaliera Universitaria San Martino, Genova, Other, Italy
Azienda Usl Toscana Nord Ovest, Livorno, Other, Italy
Istituto Europeo di Oncologia, Milano, Other, Italy
Humanitas Istituto Clinico Catanese, Misterbianco (CT), Other, Italy
Fondazione IRCCS San Gerardo dei Tintori, Monza, Other, Italy
Azienda Ospedaliera Universitaria (AOU) Federico II, Napoli, Other, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Other, Italy
Ospedale Sacro Cuore Don Calabria, Negrar Di Valpolicella, Other, Italy
Istituto Oncologico Veneto - IRCCS, Padova, Other, Italy
XX.Servizio Sanitario Regionale Emilia-Romagna Azienda Ospedaliero Universitaria di Parma, Parma, Other, Italy
IRCCS ICS Maugeri, Pavia, Other, Italy
Azienda USL 4 Prato - Ospedale Misericordia e Dolce di Prato, Prato, Other, Italy
Istituto Clinico Humanitas-Humanitas Cancer Center, Rozzano (Milano), Other, Italy
A.O.U. - Ospedali Riuniti di Ancona, Torrette (AN), Other, Italy
Azienda Provinciale per i Servizi Sanitari Provincia Autonoma di Trento - Presidio Ospedaliero S. Chiara, Trento, Other, Italy
National Cancer Center Hospital, Chuo-ku, Other, Japan
St. Luke's International Hospital, Chuo-ku, Other, Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka-shi, Other, Japan
Fukushima Medical University Hospital, Fukushima-shi, Other, Japan
University of Tsukuba Hospital, Ibaraki, Other, Japan
Tesshokai Kameda General Hospital, Kamogawa-shi, Other, Japan
Ishikawa Prefectural Central Hospital, Kanazawa-shi, Other, Japan
National Cancer Center Hospital East, Kashiwa-shi, Other, Japan
NHO Shikoku Cancer Center, Matsuyama, Other, Japan
Toranomon Hospital, Minato-ku, Other, Japan
Naha Nishi Clinic, Naha-shi, Other, Japan
Kindai University Hospital, Osakasayama-Shi, Other, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo-shi, Other, Japan
Showa University Hospital, Shinagawa-ku, Other, Japan
Kanagawa Cancer Center, Yokohama, Other, Japan
Dong-A University Hospital, Busan, Other, Korea, Republic of
Chungbuk National University Hospital, Cheongju-si, Other, Korea, Republic of
National Cancer Center, Goyang-si, Other, Korea, Republic of
Gachon University Gil Medical Center, Incheon, Other, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Other, Korea, Republic of
Korea University Anam Hospital, Seoul, Other, Korea, Republic of
Seoul National University Hospital, Seoul, Other, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Other, Korea, Republic of
Asan Medical Center, Seoul, Other, Korea, Republic of
Seoul Saint Mary's Hospital, Seoul, Other, Korea, Republic of
Ewha Womans University Mokdong Hospital, Seoul, Other, Korea, Republic of
St. Vincent's Hospital, The Catholic University of Korea, Suwon-si, Other, Korea, Republic of
Ajou University Hospital, Suwon-si, Other, Korea, Republic of
Severance Hospital, Yonsei University Health System, Wonju-si, Other, Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Netherlands Cancer Institute, Amsterdam, Other, Netherlands
Albert Schweitzer Hospital, Doedrecht, Other, Netherlands
Medisch Centrum Leeuwarden (MCL), Leeuwarden, Other, Netherlands
St. Antonius Hospital, Nieuwegein, Other, Netherlands
VieCuri Medisch Centrum, Venlo, Other, Netherlands
Uniwersyteckie Centrum Kliniczne, Gdansk, Other, Poland
Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO), Gliwice, Other, Poland
Przychodnia Lekarska KOMED Roman Karaszewski, Konin, Other, Poland
Salve Medica, Lodz, Other, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im.M.Kopernika w Lodzi, Lodz, Other, Poland
SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego, Opole, Other, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Warszawa, Other, Poland
Hospital de Braga, Braga, Other, Portugal
Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (IPO, Coimbra), Coimbra, Other, Portugal
Hospital Santa Maria, Lisboa, Other, Portugal
Hospital Cuf Descobertas, Lisboa, Other, Portugal
Champalimaud Clinical Center, Lisbon, Other, Portugal
Centro Hospitalar De Vila Nova De Gaia Espinho, Vila Nova de Gaia, Other, Portugal
Hospital General Universitario Alicante, Alicante, Other, Spain
Hospital Del Mar, Barcelona, Other, Spain
Hospital Universitari Vall d'Hebron, Barcelona, Other, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, Other, Spain
Hospital Universitario de Basurto, Bilbao, Other, Spain
Complejo Hospitalario De Caceres - Hospital General San Pedro De Alcantara, Caceres, Other, Spain
Institut Catala d'Oncologia Girona - ICO Girona, Girona, Other, Spain
Hospital Universitario Virgen de las Nieves, Granada, Other, Spain
Hospital Universitari Arnau de Vilanova, Lleida, Other, Spain
Hospital General Universitario Gregorio Maranon, Madrid, Other, Spain
Hospital Universitario Ramon y Cajal Servicio de Oncologia Medica Oficina de Ensayos Clinicos, Madrid, Other, Spain
Hospital Universitario Virgen de la Victoria, Malaga, Other, Spain
Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Other, Spain
Hospital Universitario Son Espases, Palma de Mallorca, Other, Spain
Hospital Clinico Universitario de Salamanca, Salamanca, Other, Spain
Hospital Universitario de Canarias, San Cristóbal de la Laguna, Other, Spain
Hospital Universitario Virgen del Rocio, Sevilla, Other, Spain
Valencian Institute of Oncology Foundation, Valencia, Other, Spain
Hospital Clinico Universitario de Valencia, Valencia, Other, Spain
Kantonsspital Baden AG, Baden, Other, Switzerland
Kantonsspital Winterthur (KSW), Winterthur, Other, Switzerland
Brust-Zentrum Zurich, Zurich, Other, Switzerland
Changhua Christian Hospital, Changhua, Other, Taiwan
Kaohsiung Medical University Hospital, Kaohsiung, Other, Taiwan
Taipei Medical University Hospital, New Taipei City, Other, Taiwan
China Medical University Hospital, Taichung, Other, Taiwan
National Cheng-Kung University Hospital, Tainan, Other, Taiwan
Chi Mei Hospital Liouying, Tainan, Other, Taiwan
Mackay Memorial Hospital, Taipei City, Other, Taiwan
Taipei Veterans General Hospital, Taipei, Other, Taiwan
Sun Yat-sen University Cancer Center, Taipei, Other, Taiwan
Central Hospital of the Ministry of National Defense, Taipei, Other, Taiwan
Chang Gung Memorial Hospital - Linkou, Taoyuan, Other, Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
The University of Edinburgh, Edinburgh, Other, United Kingdom
University College London Hospitals NHS Foundation Trust, London, Other, United Kingdom
Royal Free London NHS Foundation Trust, London, Other, United Kingdom
The Royal Marsden NHS Foundation Trust (RM), London, Other, United Kingdom
Christie Hospital NHS Foundation Trust, Manchester, Other, United Kingdom
The Royal Marsden NHS Foundation Trust (RM), Sutton, Other, United Kingdom
Contact Details
Name: Medical Monitor
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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