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ACTIVE NOT RECRUITING
NCT03529110
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

Trastuzumab deruxtecan (T-DXd)

T-DXd is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously.

DRUG

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