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Brief Title: A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Official Title: A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1 (DESTINY-Breast01)
Study ID: NCT03248492
Brief Summary: Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Alaska Urological Institute dba Alaska Clinical Research Center, Anchorage, Alaska, United States
Arizona Oncology Associates, Tucson, Arizona, United States
The Regents of the University of California, Los Angeles, California, United States
Sharp Clinical Oncology Research, San Diego, California, United States
University of California San Francisco, San Francisco, California, United States
Sansum Clinic, Santa Barbara, California, United States
Innovative Clinical Research Institute, LLC, Whittier, California, United States
Sylvester Comprehensive Cancer Center - Deerfield Beach, Boca Raton, Florida, United States
Specialist Global Research, Hialeah, Florida, United States
Miami Cancer Institute at Baptist Health, Inc., Miami, Florida, United States
Piedmont Cancer Institute, Atlanta, Georgia, United States
Straub Medical Center, Honolulu, Hawaii, United States
University of Hawaii, Honolulu, Hawaii, United States
Norton Healthcare, Louisville, Kentucky, United States
University of Louisville Research Foundation, Louisville, Kentucky, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, 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
Washington University School of Medicine, Saint Louis, Missouri, United States
North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood Specialists, East Setauket, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Aultman Hospital Cancer Center, Canton, Ohio, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center, Pittsburgh, Pennsylvania, United States
St Francis Hospital, Greenville, South Carolina, United States
Accurate Clinical Research, Baytown, Texas, United States
Texas Oncology, P.A., Dallas, Texas, United States
Texas Oncology - Memorial City, Houston, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
The Methodist Hospital Research Institute, Houston, Texas, United States
Texas Oncology, P.A. - Longview, Tyler, Texas, United States
The University of Texas Health Science Center at Tyler, Tyler, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Providence Regional Medical Center - Everett, Everett, Washington, United States
Imeldaziekenhuis, Bonheiden, , Belgium
Grand Hôpital de Charleroi, Charleroi, , Belgium
UZ Leuven, Leuven, , Belgium
CHU Sart Tilman, Liège, , Belgium
AZ Sint-Maarten, Mechelen, , Belgium
University of Calgary, Calgary, Alberta, Canada
Institut Sainte Catherine, Avignon, , France
CHU Besançon - Hôpital Jean Minjoz, Besançon, , France
Centre Georges François Leclerc, Dijon, , France
CHU Bordeaux - Hôpital Saint André, Gironde, , France
CH de la Rochelle - Hopital St Louis, La Rochelle, , France
Clinique Victor Hugo - Centre Jean Bernard, Le Mans, , France
Hôpital Nord - CHU Marseille, Marseille, , France
Institut Régional du Cancer de Montpellier, Montpellier, , France
Centre Catherine de Sienne, Nantes, , France
Hôpital Saint-Louis - Paris, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite, , France
CRLCC Eugene Marquis, Rennes, , France
Hôpital d'Instruction des Armees Begin, Saint-Mandé, , France
Centre Paul Strauss, Strasbourg, , France
Institut Gustave Roussy, Villejuif, , France
Ospedale San Raffaele, Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
IEO Istituto Europeo di Oncologia, Milano, , Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), Monza, , Italy
Ospedale degli Infermi, Rimini, , Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette, , Italy
NHO Shikoku Cancer Center, Matsuyama, Ehime-Ken, Japan
Toranomon Hospital, Minato-Ku, Tokyo-To, Japan
Aichi Cancer Center Hospital, Aichi, , Japan
National Cancer Center Hospital East, Chiba, , Japan
NHO Kyushu Cancer Center, Fukuoka, , Japan
Hakuaikai Sagara Hospital, Kagoshima, , Japan
Kanagawa Cancer Center, Kanagawa, , Japan
Kindai University Hospital, Osaka, , Japan
National Cancer Center Hospital, Tokyo, , Japan
St. Luke's International Hospital, Tokyo, , Japan
Cancer Institute Hospital of JFCR, Tokyo, , Japan
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , 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, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Hospital Infanta Cristina, Badajoz, , Spain
Hospital Universitari Quiron Dexeus, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
ICO l´Hospitalet - Hospital Duran i Reynals, Barcelona, , Spain
Hospital Quiron Barcelona, Barcelona, , Spain
MD Anderson Cancer Centre, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria, Málaga, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Instituto Valenciano de Oncologia IVO, Valencia, , Spain
Derriford Hospital, Plymouth, Devon, United Kingdom
Queen Mary University of London, London, Greater London, United Kingdom
University College London Hospitals, 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
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR