Spots Global Cancer Trial Database for DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
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Trial Identification
Brief Title: DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
Official Title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1
Study ID: NCT03523585
Conditions
Study Description
Brief Summary: This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body
Detailed Description: The study is designed to compare DS 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with T-DM1.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ironwood Cancer Research Centers, Chandler, Arizona, United States
UCLA Hematology Oncology - Main Site, Los Angeles, California, United States
Pacific Cancer Care, Monterey, California, United States
Sharp Memorial Hospital, San Diego, California, United States
Innovative Clinical Research Institute, Whittier, California, United States
Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut, United States
Washington Cancer Institute, Washington, District of Columbia, United States
Florida Cancer Specialists-Broadway, Fort Myers, Florida, United States
Piedmont Cancer Institute, PC, Atlanta, Georgia, United States
Kapiolani Medical Center for Women and Children/Univ of HI, Honolulu, Hawaii, United States
Loyola University Health System, Maywood, Illinois, United States
Community Hospital, Munster, Indiana, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Maine Center for Cancer Medicine, Scarborough, Maine, United States
University of Maryland, Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
Cornell-Beshore Cancer Institute, Joplin, Missouri, United States
Saint Luke's Cancer Institute, Kansas City, Missouri, United States
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC, Kansas City, Missouri, United States
Washington University, Saint Louis, Missouri, United States
North Shore Hematology Oncology Associates, PC, East Setauket, New York, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York, New York, New York, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Cleveland Clinic Main Campus, Cleveland, Ohio, United States
The Ohio State University, Columbus, Ohio, United States
Dayton Physicians, LLC, Kettering, Ohio, United States
Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center, Pittsburgh, Pennsylvania, United States
Tennessee Oncology, PLLC Chattanooga, Chattanooga, Tennessee, United States
The West Clinic, Germantown, Tennessee, United States
SCRI - Tennessee Oncology, Nashville, Tennessee, United States
UT Southwestern Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
The Methodist Hospital Research Institute, Houston, Texas, United States
The University of Texas Health Science Center at Tyler, Tyler, Texas, United States
Community Cancer Trials of Utah, Ogden, Utah, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
MultiCare Health System Institute for Research and Innovation, Tacoma, Washington, United States
St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
Liverpool Hospital, Liverpool, New South Wales, Australia
Macquarie University Hospital, Sydney, New South Wales, Australia
The Tweed Hospital, Tweed Heads, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Ashford Cancer Centre Research, Kurralta Park, South Australia, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Frankston Hospital, Frankston, Victoria, Australia
Peninsula and South Eastern Haematology & Oncology Group, Frankston, Victoria, Australia
Austin Health, Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Sunshine Hospital, Saint Albans, Victoria, Australia
South West Oncology, Warrnambool, Victoria, Australia
Ballarat Oncology & Haematology Service, Wendouree, Victoria, Australia
St John of God Subiaco Hospital, Subiaco, Western Australia, Australia
Calvary North Adelaide Hospital, Bruce, , Australia
Universitair Ziekenhuis Brussel, Bruxelles, , Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
AZ Maria Middelares, Gent, , Belgium
Az Groeninge, Kortrijk, , Belgium
UZ Leuven, Leuven, , Belgium
CHU UCL Namur site de Sainte Elisabeth, Namur, , Belgium
NOB - Núcleo de Oncologia da Bahia, Salvador, Bahia, Brazil
AMO - Assistência Multidisciplinar em Oncologia, Salvador, Bahia, Brazil
Pronutrir, Fortaleza, Ceará, Brazil
Oncobio Servicos de Saude, Nova Lima, Minas Gerais, Brazil
HGB - Hospital Giovanni Battista - Mãe de Deus Center, Porto Alegre, Rio Grande Do Sul, Brazil
CliniOnco - Tratamento Integrado do Câncer, Porto Alegre, Rio Grande Do Sul, Brazil
Escosteguy Barrios, Carlos Henrique, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Nossa Senhora da Conceição, Porto Alegre, Rio Grande Do Sul, Brazil
Clínica de Neoplasias Litoral Ltda., Itajaí, Santa Catarina, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André, Sao Paulo, Brazil
IBCC - Instituto Brasileiro de Controle do Câncer, São Paulo, Sao Paulo, Brazil
COI - Clínicas Oncológicas Integradas, Rio De Janeiro, , Brazil
Sociedade Beneficiente de Senhoras Hospital Sírio Libanês, São Paulo, , Brazil
A. C. Camargo Cancer Center, São Paulo, , Brazil
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice v Motole, Prague 5, , Czechia
Nemocnice Na Bulovce, Praha, , Czechia
Hôpital Nord - CHU Marseille, Marseille cedex 20, Bouches-du-Rhône, France
Centre François Baclesse, Caen Cedex 05, Calvados, France
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie, Plérin, Cotes d'Armor, France
Centre Georges François Leclerc, Dijon cedex, Côte-d'Or, France
CHU Besançon - Hôpital Jean Minjoz, Besançon, Doubs, France
CHU Brest - Hôpital Morvan, Brest Cedex, Finistere, France
Hôpital Privé d'Antony, Antony, Hauts De Seine, France
Centre René Huguenin, Saint-Cloud, Hauts De Seine, France
Clinique Clementville, Montpellier, Herault, France
Institut Régional du Cancer de Montpellier, Montpellier, Herault, France
CRLCC Eugene Marquis, Rennes cedex, Ille Et Vilaine, France
Centre Oscar Lambret, Lille cedex, Nord, France
Centre de cancerologie les Dentellieres, Valenciennes, Nord, France
Institut Curie - site de Paris, Paris Cedex 05, Paris, France
Centre Hospitalier de la côte Basque, Bayonne Cedex, Pyrenees Atlantiques, France
Centre Hospitalier Lyon Sud, Pierre Benite cedex, Rhone, France
Clinique Victor Hugo - Centre Jean Bernard, Le Mans Cedex 02, Sarthe, France
Centre Henri Becquerel, Rouen, Seine Maritime, France
Institut Sainte Catherine, Avignon Cedex 9, Vaculuse, France
Institut Gustave Roussy, Villejuif cedex, Val De Marne, France
Institut Régional du Cancer de Montpellier, Montpellier, , France
Institut Curie - site de Paris, Paris, , France
Hopital Tenon, Paris, , France
Klinikum rechts der Isar der TU Muenchen, Muenchen, Bayern, Germany
Marienhospital Bottrop gGmbH, Bottrop, Rheinland Pfalz, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck, Luebeck, Schleswig Holstein, Germany
Helios-Kliniken Berlin-Buch, Berlin, , Germany
Universitaetsklinikum Duesseldorf AoeR, Düsseldorf, , Germany
Universitaetsklinikum Erlangen, Erlangen, , Germany
Kliniken Koeln, Koeln, , Germany
Universitaetsklinikum Leipzig AoeR, Leipzig, , Germany
Klinikum der Universitaet Muenchen - Campus Grosshardern, Munich, , Germany
Universitaetsklinikum Muenster, Müenster, , Germany
Haematologisch-Onkologische Schwerpunktpraxis, Troisdorf, , Germany
251 General Air Force Hospital, Athens, , Greece
General Hospital of Athens "Alexandra", Athens, , Greece
General Oncology Hospital of Kifissia " Agioi Anargyroi", Athens, , Greece
University General Hospital of Heraklion, Heraklion, , Greece
Euromedica General Clinic Thessaloniki, Thessaloníki, , Greece
Rambam Health Care Center, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah University Hospital - Ein Kerem, Jerusalem, , Israel
Sapir Medical Center, Meir Hospital, Kfar Saba, , Israel
Rabin Medical Center-Beilinson Campus, Petah tikva, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), Monza, Milano, Italy
IRCCS Centro di Riferimento Oncologico, Aviano, Pordenone, Italy
Ospedale Sacro Cuore Don Calabria, Negrar, Verona, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII), Bergamo, , Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna, , Italy
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna, Cona, , Italy
Istituto Nazionale per la Ricerca sul Cancro di Genova, Genova, , Italy
Azienda Ospealiera della Provincia di Lecco, Lecco, , Italy
Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte, Messina, , Italy
Ospedale San Raffaele, Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
IEO Istituto Europeo di Oncologia, Milano, , Italy
A.O.U. Policlinico di Modena, Modena, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, , Italy
IOV - Istituto Oncologico Veneto IRCCS, Padova, , Italy
Azienda Ospedaliero Universitaria di Parma, Parma, , Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino, , Italy
Fukushima Medical University Hospital, Fukushima-shi, Fukushima-Ken, Japan
Kindai University Hospital, Osakasayama-shi, Osaka-Fu, Japan
Kindai University Hospital, Ōsakasayama-shi, Osaka-Fu, Japan
National Cancer Center Hospital, Chuo Ku, Tokyo-To, Japan
NHO Shikoku Cancer Center, Ehime, , Japan
NHO Kyushu Cancer Center, Fukuoka, , Japan
Hiroshima City Hiroshima Citizens Hospital, Hiroshima, , Japan
NHO Hokkaido Cancer Center, Hokkaido, , Japan
Hyōgo College of Medicine Hospital, Hyōgo, , Japan
St. Marianna University School of Medicine Hospital, Kanagawa, , Japan
Kanagawa Cancer Center, Kanagawa, , Japan
Kyoto University Hospital, Kyoto, , Japan
Tohoku University Hospital, Miyagi, , Japan
Aichi Cancer Center Hospital, Nagoya, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Okayama University Hospital, Okayama, , Japan
NHO Osaka National Hospital, Osaka, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Saitama Cancer Center, Saitama, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
Toranomon Hospital, Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Tokyo Medical University Hospital, Tokyo, , Japan
Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Inha University Hospital, Incheon, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital, Suwon-si, Gyeonggi-do, Korea, Republic of
Ajou University Hospital, Suwon, Gyeonggi-do, Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
ICO Badalona - Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
ICO l'Hospitalet - Hospital Duran i Reynals, L'Hospitalet De Llobregat, Barcelona, Spain
Hospital de Especialidades de Jerez de la Frontera, Jerez De La Frontera, Cádiz, Spain
Complejo Hospitalario Universitario A Coruña, A Coruña, La Coruña, Spain
Hospital Universitario de Canarias, San Cristobal de la Laguna, Tenerife, Spain
Hospital Infanta Cristina, Badajoz, , Spain
Hospital Quironsalud Barcelona, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Universitari Arnau de Vilanova, Lleida, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
MD Anderson Cancer Centre, Madrid, , Spain
Hospital Universitario Clinico San Carlos, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria, Málaga, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Instituto Valenciano de Oncologia IVO, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Acibadem Adana Hospital, Adana, , Turkey
Adana Numune Training and Research Hospital, Adana, , Turkey
Ankara Yildirim Beyazit Uni. Med. Fac.Ankara City Hospital, Ankara, , Turkey
Akdeniz University Medical Faculty, Antalya, , Turkey
Uludag University Medical Faculty, Bursa, , Turkey
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty, Istanbul, , Turkey
Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital, Istanbul, , Turkey
Medipol University Medical Faculty, Istanbul, , Turkey
Medical Park Goztepe Hospital, Istanbul, , Turkey
Istanbul Medeniyet Uni Goztepe Training & Research Hospital, Istanbul, , Turkey
Kartal Lutfi Kirdar Research and Training Hospital, Istanbul, , Turkey
Izmir Medicalpark Hospital, İzmir, , Turkey
Konya Necmettin Erbakan University Meram Faculty of Medicine, Konya, , Turkey
Sakarya Traning and Research Hospital, Sakarya, , Turkey
Medical Park Samsun Hastanesi, Samsun, , Turkey
Namik Kemal University, Tekirdağ, , Turkey
Royal Cornwall Hospital, Truro, Cornwall, United Kingdom
Royal Devon and Exeter Hospital (Wonford), Exeter, Devon, United Kingdom
Derriford Hospital, Plymouth, Devon, United Kingdom
Aberdeen Royal Infirmary, Aberdeen, Grampian Region, United Kingdom
Queen Mary University of London, London, Greater London, United Kingdom
University College London Hospitals, London, Greater London, United Kingdom
Sarah Cannon Research Institute UK, London, Greater London, United Kingdom
Western General Hospital, Edinburgh, Lothian Region, United Kingdom
Nottingham University Hospitals City Campus, Nottingham, Nottinghamshire, United Kingdom
Contact Details
Name: Global Team Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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