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]

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

524

Participants

Timeline

Start Date

August 9, 2018

Primary Completion Date

May 21, 2021

Study Completion Date

July 30, 2026

Conditions
Breast Cancer
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.

Trial Locations (164)

100

National Taiwan University Hospital, Taipei

112

Koo Foundation, Sun Yat-Sen Cancer Center, Taipei

704

National Cheng Kung University Hospital, Tainan City

1000

Institut Jules-Bordet, Brussels

1090

Universitair Ziekenhuis Brussel, Brussels

2485

The Tweed Hospital, Tweed Heads

2650

Universitair Ziekenhuis Antwerpen, Edegem

3000

Peter MacCallum Cancer, Melbourne

Universitaire Ziekenhuizen Leuven, Leuven

3128

Box Hill Hospital, Box Hill

3199

Peninsula and South Eastern Haematology & Oncology Group, Frankston

4102

Princess Alexandra Hospital, Woolloongabba

5000

CHU UCL Namur site de Sainte Elisabeth, Namur

6007

Hospital Infanta Cristina, Badajoz

6008

St John of God Subiaco Hospital, Subiaco

8023

IOB-Institute of Oncology, Barcelona

9000

AZ Sint-Lucas - Campus Sint-Lucas, Ghent

10126

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino

11217

Taipei Veterans General Hospital, Taipei

11733

North Shore Hematology Oncology Associates, PC, East Setauket

13620

Seoul National University Bundang Hospital, Seongnam-si

13915

Hôpital Nord - CHU Marseille, Marseille

14076

Centre François Baclesse, Caen

14642

University of Rochester, Rochester

15006

Complejo Hospitalario Universitario A Coruña, A Coruña

15213

Magee-Womens Hospital of UPMC, Pittsburgh

15706

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela

16132

Istituto Nazionale per la Ricerca sul Cancro di Genova, Genova

20010

Washington Cancer Institute, Washington D.C.

20089

Istituto Clinico Humanitas, Rozzano

20132

Ospedale San Raffaele, Milan

20141

IEO Istituto Europeo di Oncologia, Milan

20900

Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), U.O Oncologia Medica, Monza

21079

Centre Georges François Leclerc, Dijon

22190

CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie, Plérin

23538

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck, Lübeck

23900

Azienda Ospealiera della Provincia di Lecco, Lecco

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII), Bergamo

25030

CHRU Jean Minjoz, Besançon

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

27157

Wake Forest University Baptist Medical Center, Winston-Salem

28007

Hospital General Universitario Gregorio Maranon, Madrid

28033

MD Anderson Cancer Centre, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Hospital Universitario Clinico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

29010

Hospital Clinico Universitario Virgen de la Victoria, Málaga

30318

Piedmont Cancer Institute, PC, Atlanta

33076

Institut Bergonié, Bordeaux

33081

IRCCS Centro di Riferimento Oncologico, Aviano

33705

Florida Cancer Specialists NORTH, St. Petersburg

33916

Florida Cancer Specialists-Broadway, Fort Myers

34298

ICM Val d'Aurelle, Montpellier

35042

CRLCC Eugene Marquis, Rennes

37205

Tennessee Oncology- St Thomas Location, Nashville

37232

Vanderbilt Breast Center at One Hundred Oaks, Nashville

38320

Hospital Universitario de Canarias, San Cristóbal de La Laguna

40138

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna

40207

Norton Cancer Institute, Louisville

40225

Universitaetsklinikum Duesseldorf AoeR, Düsseldorf

40447

China Medical University Hospital, Taichung

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen del Rocio, Seville

41124

A.O.U. Policlinico di Modena, Modena

43100

Azienda Ospedaliero Universitaria di Parma, Parma

43210

The Ohio State University, Columbus

44106

Seidman Cancer Center, Cleveland

44124

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna, Cona

44805

ICO - Site René Gauducheau, Saint-Herblain

45267

University of Cincinnati Medical Center, Cincinnati

45409

Dayton Physicians, LLC, Kettering

46236

Marienhospital Bottrop gGmbH, Bottrop

49055

ICO - Site Paul Papin, Angers

53840

Haematologisch-Onkologische Schwerpunktpraxis, Troisdorf

59300

Centre de cancerologie les Dentellieres, Valenciennes

60153

Loyola University Health System, Maywood

67000

Centre Paul Strauss, Strasbourg

68198

University of Nebraska Medical Center, Omaha

69373

Centre Leon Berard, Lyon

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

72015

Clinique Victor Hugo - Centre Jean Bernard, Le Mans

75005

Institut Curie - site de Paris, Paris

75010

Hôpital Saint-Louis, Paris

75020

Hopital Tenon, Paris

75390

UT Southwestern Medical Center, Dallas

75708

The University of Texas Health Science Center at Tyler, Tyler

77030

Houston Methodist Hospital / Houston Methodist Cancer Center, Houston

MD Anderson Cancer Center, Houston

77090

Millennium Oncology, Houston

80131

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

80637

Rotkreuzklinikum Muenchen gGmbH, Munich

81675

Klinikum rechts der Isar der TU Muenchen, Munich

84918

Institut Sainte Catherine, Avignon

90095

UCLA Hematology Oncology, Los Angeles

90603

Innovative Clinical Research Institute, Whittier

92110

Centre René Huguenin, Saint-Cloud

92123

Sharp Memorial Hospital, San Diego

94115

University of California San Francisco, San Francisco

94160

Hôpital d'Instruction des Armees Begin, Saint-Mandé

94805

Institut Gustave Roussy, Villejuif

98001

MultiCare Health System Institute for Research and Innovation, Auburn

98158

Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte, Messina

100021

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

100730

Beijing Hospital, Beijing

110042

Liaoning Cancer Hospital & Institute, Shenyang

130021

The First Hospital of Jilin University, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

200032

Fudan University Shanghai Cancer Center, Shanghai

300060

Tianjin Medical University Cancer Institute & Hospital, Tianjin

310000

Sir Run Run Shaw Hospital Xiasha Branch, Zhejiang University, School of Medicine, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

510060

Sun Yat-sen University, Cancer Center, Guangzhou

510120

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

610041

West China Hospital, Sichuan University, Chengdu

02215

Dana-Farber Cancer Institute, Boston

40170-110

NOB - Nucleo de Oncologia da Bahia, Salvador

91350-200

Hospital Nossa Senhora da Conceição, Porto Alegre

88301-220

Catarina Pesquisa Clinica, Itajaí

09060-650

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André

01246-000

ICESP - Instituto do Cancer do Estado de São Paulo Octavio Frias de Oliveira, São Paulo

01317-001

Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda., São Paulo

22793-080

Instituto Americas, Rio de Janeiro

01509-900

A. C. Camargo Cancer Center, São Paulo

T2N 4N2

Tom Baker Cancer Centre, Calgary

M4N 3M5

Toronto Sunnybrook Hospital, Toronto

H3T 1M5

St. Mary's Hospital, Montreal

91-54

Universitaetsklinikum Erlangen, Erlangen

00000

The Chinese, Hong Kong

The University of Hong Kong, Shatin

162-8655

Center Hospital of the National Center for Global Health and Medicine, Shinjuku-Ku

464-8681

Aichi Cancer Center Hospital, Aichi

791-0280

NHO Shikoku Cancer Center, Ehime

811-1395

NHO Kyushu Cancer Center, Fukuoka

730-8518

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

003-0804

NHO Hokkaido Cancer Center, Hokkaido

241-8515

Kanagawa Cancer Center, Kanagawa

860-8556

Kumamoto University Hospital, Kumamoto

951-8566

Niigata Cancer Center, Niigata

700-8558

Okayama University Hospital, Okayama

540-0006

NHO Osaka National Hospital, Osaka

541-8567

Osaka International Cancer Institute, Osaka

362-0806

Saitama Cancer Center, Saitama

411-8777

Shizuoka Cancer Center, Shizuoka

104-0045

National Cancer Center Hospital, Tokyo

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

142-8666

Showa University Hospital, Tokyo

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08908

ICO l'Hospitalet - Hospital Duran i Reynals, L'Hospitalet de Llobregat

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

EX2 5DW

Royal Devon and Exeter Hospital (Wonford), Exeter

AB25 2ZB

Aberdeen Royal Infirmary, Aberdeen

EC1M 6BQ

Queen Mary University of London, London

NW1 2PG

University College London Hospitals, London

SE1 9RY

Guy's Hospital, London

W1G 6AD

Sarah Cannon Research Institute UK, London

M20 4BX

The Christie Hospital, Manchester

EH4 2XU

Western General Hospital, Edinburgh

NG5 1PB

Nottingham University Hospitals City Campus, Nottingham

GU2 7XX

Royal Surrey County Hospital, Guildford

Sponsors
All Listed Sponsors
collaborator

Daiichi Sankyo Co., Ltd.

INDUSTRY

collaborator

AstraZeneca

INDUSTRY

lead

Daiichi Sankyo

INDUSTRY