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DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]
Sponsor: Daiichi Sankyo
Summary
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
Official title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
524
Start Date
2018-08-09
Completion Date
2026-07-30
Last Updated
2025-10-21
Healthy Volunteers
No
Conditions
Interventions
Trastuzumab deruxtecan (T-DXd)
T-DXd is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously.
Ado-trastuzumab emtansine (T-DM1)
The treatment will be in accordance with the approved label.
Locations (164)
UCLA Hematology Oncology
Los Angeles, California, United States
Sharp Memorial Hospital
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Florida Cancer Specialists-Broadway
Fort Myers, Florida, United States
Florida Cancer Specialists NORTH
St. Petersburg, Florida, United States
Piedmont Cancer Institute, PC
Atlanta, Georgia, United States
Loyola University Health System
Maywood, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
North Shore Hematology Oncology Associates, PC
East Setauket, New York, United States
University of Rochester
Rochester, New York, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Seidman Cancer Center
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Dayton Physicians, LLC
Kettering, Ohio, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Tennessee Oncology- St Thomas Location
Nashville, Tennessee, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist Hospital / Houston Methodist Cancer Center
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Millennium Oncology
Houston, Texas, United States
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States
MultiCare Health System Institute for Research and Innovation
Auburn, Washington, United States
The Tweed Hospital
Tweed Heads, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Peninsula and South Eastern Haematology & Oncology Group
Frankston, Victoria, Australia
Peter MacCallum Cancer
Melbourne, Victoria, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia
Institut Jules-Bordet
Brussels, Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
AZ Sint-Lucas - Campus Sint-Lucas
Ghent, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
CHU UCL Namur site de Sainte Elisabeth
Namur, Belgium
NOB - Nucleo de Oncologia da Bahia
Salvador, Estado de Bahia, Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil
Catarina Pesquisa Clinica
Itajaí, Santa Catarina, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, São Paulo, Brazil
ICESP - Instituto do Cancer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, São Paulo, Brazil
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda.
São Paulo, São Paulo, Brazil
Instituto Americas
Rio de Janeiro, Brazil
A. C. Camargo Cancer Center
São Paulo, Brazil
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Toronto Sunnybrook Hospital
Toronto, Ontario, Canada
St. Mary's Hospital
Montreal, Quebec, Canada
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital Xiasha Branch, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Centre Paul Strauss
Strasbourg, Bas Rhin, France
Hôpital Nord - CHU Marseille
Marseille, Bouches-du-Rhone, France
Centre François Baclesse
Caen, Calvados, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, Cedex 02, Sarthe, France
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
Plérin, Cotes d'Armor, France
Centre Georges François Leclerc
Dijon, Côte-d'Or, France
CHRU Jean Minjoz
Besançon, Doubs, France
Institut Bergonié
Bordeaux, Gironde, France
Centre René Huguenin
Saint-Cloud, Hauts De Seine, France
ICM Val d'Aurelle
Montpellier, Herault, France
CRLCC Eugene Marquis
Rennes, Ille Et Vilaine, France
ICO - Site René Gauducheau
Saint-Herblain, Loire Atlantique, France
ICO - Site Paul Papin
Angers, Maine Et Loire, France
Centre de cancerologie les Dentellieres
Valenciennes, Nord, France
Centre Leon Berard
Lyon, Rhone, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhone, France
Institut Sainte Catherine
Avignon, Vaculuse, France
Hôpital d'Instruction des Armees Begin
Saint-Mandé, Val De Marne, France
Institut Gustave Roussy
Villejuif, Val De Marne, France
Institut Curie - site de Paris
Paris, France
Hôpital Saint-Louis
Paris, France
Hopital Tenon
Paris, France
Universitaetsklinikum Erlangen
Erlangen, Bavaria, Germany
Rotkreuzklinikum Muenchen gGmbH
Munich, Bavaria, Germany
Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, Germany
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf, North Rhine-Westphalia, Germany
Haematologisch-Onkologische Schwerpunktpraxis
Troisdorf, North Rhine-Westphalia, Germany
Marienhospital Bottrop gGmbH
Bottrop, Rhineland-Palatinate, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, Schleswig-Holstein, Germany
The Chinese
Hong Kong, Hong Kong
The University of Hong Kong
Shatin, Hong Kong
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Cona, Ferrara, Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), U.O Oncologia Medica
Monza, Milano, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
IRCCS Centro di Riferimento Oncologico
Aviano, Pordenone, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, 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
Milan, Italy
IEO Istituto Europeo di Oncologia
Milan, Italy
A.O.U. Policlinico di Modena
Modena, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Italy
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo-To, Japan
Aichi Cancer Center Hospital
Aichi, 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
Kanagawa Cancer Center
Kanagawa, Japan
Kumamoto University Hospital
Kumamoto, Japan
Niigata Cancer Center
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
National Cancer Center Hospital
Tokyo, Japan
The Cancer Institute Hospital of JFCR
Tokyo, Japan
Showa University Hospital
Tokyo, Japan
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Universitario Virgen Macarena
Seville, Sevill, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Hospital Infanta Cristina
Badajoz, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
IOB-Institute of Oncology
Barcelona, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
MD Anderson Cancer Centre
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Universitario Clinico San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Koo Foundation, Sun Yat-Sen Cancer Center
Taipei, Taiwan
Royal Devon and Exeter Hospital (Wonford)
Exeter, 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
Guy's Hospital
London, Greater London, United Kingdom
Sarah Cannon Research Institute UK
London, Greater London, United Kingdom
The Christie Hospital
Manchester, Greater Manchester, 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