Spots Global Cancer Trial Database for Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
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Trial Identification
Brief Title: Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
Official Title: A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
Study ID: NCT03734029
Conditions
Study Description
Brief Summary: This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: * Cannot be removed by an operation * Has spread to other parts of the body
Detailed Description: This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants. The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ironwood Cancer & Research Centers - Chandler II, Chandler, Arizona, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Cancer Treatment Centers of America at Western Regional Medical Center, Goodyear, Arizona, United States
UCLA School of Medicine, Los Angeles, California, United States
Stanford Cancer Institute, Palo Alto, California, United States
Cancer Care Associates Medical Group, Inc. TORI, Redondo Beach, California, United States
University of California at San Francisco (PARENT), San Francisco, California, United States
Eastern Connecticut Hematology/Oncology Assoc., Norwich, Connecticut, United States
Christiana Care Health Services, Inc., Newark, Delaware, United States
Sylvester Comprehensive Cancer Center - Deerfield Beach, Boca Raton, Florida, United States
Florida Cancer Specialists (South Region), Fort Myers, Florida, United States
Memorial Healthcare System MRH Cancer Center, Hollywood, Florida, United States
Orlando Health, Inc., Orlando, Florida, United States
Moffitt Cancer Center -Tampa, Tampa, Florida, United States
Cancer Treatment Centers of America-Georgia, Newnan, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Cancer Treatment Centers of America, Zion, Illinois, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Touro Infirmary, New Orleans, Louisiana, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States
Saint Barnabas Medical Center, Livingston, New Jersey, United States
New York University Medical Center, New York, New York, United States
Memorial Sloan Kettering Hospital, New York, New York, United States
Weill Cornell Medicine Breast Center, New York, New York, United States
The Cleveland Clinic Foundation, Cleveland, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, United States
St Francis Hospital, Greenville, South Carolina, United States
Brig Center for Cancer Care and Survivorship, Knoxville, Tennessee, United States
Baptist Cancer Center, Memphis, Tennessee, United States
Tennessee Oncology - Skyline Satellite, Nashville, Tennessee, United States
BloomTrials Clinical Research, LLC, Dallas, Texas, United States
The Methodist Hospital Research Institute, Houston, Texas, United States
University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics, Houston, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Medizinische Universität Innsbruck, Innsbruck, , Austria
Kepler Universitätsklinikum, Linz, , Austria
LKH - Universitätsklinikum der PMU Salzburg, Salzburg, , Austria
AKH - Medizinische Universität Wien (4305), Vienna, , Austria
Klinikum Wels-Grieskirchen GmbH, Wels, , Austria
Institut Jules Bordet, Bruxelles, , Belgium
Universitair Ziekenhuis Brussel, Bruxelles, , Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
UZ Leuven, Leuven, , Belgium
Grand Hôpital de Charleroi, Loverval, , Belgium
CHU UCL Namur, Namur, , Belgium
Centre Hospitalier Wallonie picarde - Site IMC, Tournai, , Belgium
Tom Baker Cancer Center, Calgary, Alberta, Canada
Toronto Sunnybrook Hospital, Toronto, Ontario, Canada
McGill University - Dept. Oncology Clinical Research Program, Montréal, Quebec, Canada
Anhui Provincial Hospital, Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Chinese PLA General Hospital, Beijing, Beijing, China
Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA, Fuzhou, Fujian, China
Sun Yat-sen Memorial hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Hubei Cancer Hospital, Wuhan, Hubei, China
The Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu, China
The First Hospital of Jilin University, Chang chun, Jilin, China
Jilin Cancer Hospital, Chang chun, Jilin, China
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China
Linyi Cancer Hospital, Linyi, Shandong, China
Shanghai General Hospital, Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Institut Paoli Calmettes, Marseille cedex 9, Bouches-du-Rhône, France
Centre François Baclesse, Caen, Calvados, France
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie, Plérin, Cotes d'Armor, France
CHU Brest - Hôpital Morvan, Brest Cedex, Finistere, France
Institut Bergonié, Bordeaux cedex, Gironde, France
Clinique Clementville, Montpellier, Herault, France
Institut Régional du Cancer de Montpellier, Montpellier, Herault, France
CRLCC Eugene Marquis, Rennes-cedex, Ille Et Vilaine, France
ICO - Site René Gauducheau, Saint-Herblain, Loire Atlantique, France
Centre Hospitalier Emile Roux, Le Puy-en-Velay, Loiret, France
ICO - Site Paul Papin, Angers Cedex 2, Maine Et Loire, France
Centre Hospitalier Valenciennes, Valenciennes, Nord, France
Hôpital Saint-Louis - Paris, Paris Cedex 10, Paris, France
Clinique Victor Hugo - Centre Jean Bernard, Le Mans Cedex 02, Sarthe, France
Institut Sainte Catherine, Avignon Cedex 9, Vaculuse, France
Hôpital d'Instruction des Armees Begin*, Saint Mande, Val De Marne, France
Institut Gustave Roussy, Villejuif cedex, Val De Marne, France
Institut Curie - site de Paris, Paris, , France
Hopital Tenon, Paris, , France
Universitaetsklinikum Heidelberg, Heidelberg, Baden Wuerttemberg, Germany
Klinikum der Universitaet Muenchen - Campus Grosshardern, Munich, Bayern, Germany
General Hospital of Athens "Alexandra", Athens, , Greece
General Oncology Hospital of Kifissia " Agioi Anargyroi", Athens, , Greece
Athens Medical Center, Athens, , Greece
University General Hospital of Heraklion, Heraklion, , Greece
University General Hospital of Larissa, Larissa, , Greece
Bioclinic Thessaloniki, Thessaloníki, , Greece
Euromedica General Clinic Thessaloniki, Thessaloníki, , Greece
General Hospital Papageorgiou, Thessaloníki, , Greece
Interbalkan Hospital of Thessaloniki, Thessaloníki, , Greece
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Budapest, , Hungary
Orszagos Onkologiai Intezet, Budapest, , Hungary
Debreceni Egyetem, Debrecen, , Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Gyula, , Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Nyiregyhaza, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok, , Hungary
Rambam Health Care Center, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah University Hospital - Ein Kerem, Jerusalem, , Israel
Rabin Medical Center-Beilinson Campus, Petah tikva, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
Kaplan Medical Center, Rechovot, , Israel
Ziv Medical Center, Safed, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliera Card. G. Panico, Tricase, Lecce, Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), Monza, Milano, Italy
Istituto Clinico Humanitas, Rozzano, Milano, Italy
Ospedale Sacro Cuore Don Calabria, Negrar, Verona, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna, , Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili), Brescia, , Italy
Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico, Catania, , Italy
Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario, Catanzaro, , Italy
IEO Istituto Europeo di Oncologia, Milano, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, , Italy
Ospedale degli Infermi, Rimini, , Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, , Italy
Aichi Cancer Center Hospital, Nagoya, Aichi-Ken, Japan
National Cancer Center Hospital East, Kashiwa-shi, Chiba-Ken, Japan
NHO Shikoku Cancer Center, Matsuyama-shi, Ehime-Ken, Japan
NHO Kyushu Cancer Center, Fukuoka-shi, Fukuoka-Ken, Japan
Fukushima Medical University Hospital, Fukushima, Fukushima-Ken, Japan
Hiroshima City Hiroshima Citizens Hospital, Hiroshima-shi, Hiroshima-Ken, Japan
NHO Hokkaido Cancer Center, Sapporo-shi, Hokkaido, Japan
Hyogo College of Medicine Hospital, Nishinomiya-shi, Hyogo-Ken, Japan
Hakuaikai Sagara Hospital, Kagoshima, Kagoshima-Ken, Japan
Tokai University Hospital, Isehara, Kanagawa-Ken, Japan
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
NHO Osaka National Hospital, Osaka-shi, Osaka-Fu, Japan
Kindai University Hospital, Onohigashi, Osakasayama-shi, Japan
Saitama Cancer Center, Kitaadachi-gun, Saitama-Ken, Japan
Shizuoka Cancer Center, Sunto-gun, Shizuoka-Ken, Japan
Cancer Institute Hospital of JFCR, Koto-Ku, Tokyo-To, Japan
Toranomon Hospital, Minato-Ku, Tokyo-To, Japan
Showa University Hospital, Shinagawa-Ku, Tokyo-To, Japan
Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-do, Korea, Republic of
National Cancer Center, Goyang-si, Gyeonggi-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
Ajou University Hospital, Suwon, Gyeonggi-do, Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
Seoul National University Hospital, 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
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Hospital de Braga, Braga, , Portugal
Centro Hospitalar do Alto do Ave, EPE, Guimarães, , Portugal
Fundação Champalimaud, Lisboa, , Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisboa, , Portugal
Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano), Matosinhos, , Portugal
Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António, Porto, , Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE, Porto, , Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião, Santa Maria Da Feira, , Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E, Vila Nova De Gaia, , Portugal
Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE, Vila Real, , Portugal
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow, , Russian Federation
SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement, Moscow, , Russian Federation
SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital", Yaroslavl, , Russian Federation
ICO l'Hospitalet - Hospital Duran i Reynals, L'Hospitalet De Llobregat, Barcelona, Spain
Hospital Universitario Donostia, San Sebastián, Guipuzcoa, Spain
Complejo Hospitalario Universitario A Coruña, A Coruña, La Coruña, Spain
Hospital Universitario de Canarias, San Cristobal de la Laguna, Tenerife, Spain
Hospital de Basurto, Bilbao, Vizcaya, Spain
Hospital del Mar, Barcelona, , Spain
Hospital Quironsalud Barcelona, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
MD Anderson Cancer Centre, Madrid, , Spain
Hospital Ruber Internacional, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario Clinico San Carlos, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria, Málaga, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Instituto Valenciano de Oncologia IVO, Valencia, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Karolinska universitetssjukhuset - Solna, Solna, , Sweden
Länssjukhuset Sundsvall-Härnösand, Sundsvall, , Sweden
Akademiska Sjukhuset, Uppsala, , Sweden
Hirslanden Medical Center, Aarau, , Switzerland
Universitaetsspital Basel, Basel, , Switzerland
Kantonsspital Graubuenden, Chur, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Kantonsspital St. Gallen, Saint Gallen, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
Universitaetsspital Zuerich, Zürich, , Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Royal Cornwall Hospital, Truro, Cornwall, United Kingdom
Queen Mary University of London, London, Greater London, United Kingdom
University College London Hospitals, London, Greater London, United Kingdom
Royal Free Hospital, London, Greater London, United Kingdom
Western General Hospital, Edinburgh, Lothian Region, United Kingdom
Nottingham University Hospitals City Campus, Nottingham, Nottinghamshire, United Kingdom
Royal Surrey County Hospital, Guildford, Surrey, United Kingdom
Contact Details
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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