DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

608

Participants

Timeline

Start Date

August 1, 2018

Primary Completion Date

June 30, 2022

Study Completion Date

July 31, 2025

Conditions
Breast Cancer
Interventions
DRUG

Trastuzumab deruxtecan

DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as intravenous (IV) dose

DRUG

Capecitabine

Investigator's choice Standard of Care when combined with trastuzumab or lapatinib

DRUG

Lapatinib

Investigator's choice Standard of Care when combined with capecitabine

DRUG

Trastuzumab

Investigator's choice Standard of Care when combined with capecitabine

Trial Locations (227)

1090

Universitair Ziekenhuis Brussel, Brussels

1200

Cliniques Universitaires Saint-Luc, Brussels

2010

St Vincent's Hospital Sydney, Darlinghurst

2109

Macquarie University Hospital, Sydney

2170

Liverpool Hospital, Liverpool

2485

The Tweed Hospital, Tweed Heads

2614

Calvary North Adelaide Hospital, Bruce

3000

Peter MacCallum Cancer Centre, Melbourne

UZ Leuven, Leuven

3021

Sunshine Hospital, Saint Albans

3084

Austin Health, Heidelberg

3128

Box Hill Hospital, Box Hill

3199

Frankston Hospital, Frankston

Peninsula and South Eastern Haematology & Oncology Group, Frankston

3280

South West Oncology, Warrnambool

3355

Ballarat Oncology & Haematology Service, Wendouree

4102

Princess Alexandra Hospital, Woolloongabba

5000

CHU UCL Namur site de Sainte Elisabeth, Namur

5037

Ashford Cancer Centre Research, Kurralta Park

6008

St John of God Subiaco Hospital, Subiaco

6800

Ankara Yildirim Beyazit Uni. Med. Fac.Ankara City Hospital, Ankara

8003

Hospital del Mar, Barcelona

8500

Az Groeninge, Kortrijk

9000

AZ Maria Middelares, Ghent

10065

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York, New York

10126

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

10408

National Cancer Center, Goyang-si

11407

Hospital de Especialidades de Jerez de la Frontera, Jerez de la Frontera

11525

251 General Air Force Hospital, Athens

11528

"General Hospital of Athens Alexandra", Athens

11733

North Shore Hematology Oncology Associates, PC, East Setauket

13125

Helios-Kliniken Berlin-Buch, Berlin

13620

Seoul National University Bundang Hospital, Seongnam-si

13915

Hôpital Nord - CHU Marseille, Marseille

14076

Centre François Baclesse, Caen

14564

"General Oncology Hospital of Kifissia Agioi Anargyroi", Athens

15006

Complejo Hospitalario Universitario A Coruña, A Coruña

15212

Allegheny General Hospital, Pittsburgh

15213

UPMC Cancer Center, Pittsburgh

16059

Uludag University Medical Faculty, Bursa

16132

Istituto Nazionale per la Ricerca sul Cancro di Genova, Genova

16247

The Catholic University of Korea, St. Vincent's Hospital, Suwon

16499

Ajou University Hospital, Suwon

19104

Abramson Cancer Center, Philadelphia

20010

Washington Cancer Institute, Washington D.C.

20132

Ospedale San Raffaele, Milan

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

IEO Istituto Europeo di Oncologia, Milan

20900

Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), Monza

21079

Centre Georges François Leclerc, Dijon

21201

University of Maryland, Baltimore

22031

Virginia Cancer Specialists, PC, Fairfax

22190

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

22332

Inha University Hospital, Incheon

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

CHU Besançon - Hôpital Jean Minjoz, Besançon

25198

Hospital Universitari Arnau de Vilanova, Lleida

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

28007

Hospital General Universitario Gregorio Marañon, Madrid

28033

MD Anderson Cancer Centre, Madrid

28040

Hospital Universitario Clinico San Carlos, Madrid

28644

Chungbuk National University Hospital, Cheongju-si

29010

Hospital Clinico Universitario Virgen de la Victoria, Málaga

29609

CHU Brest - Hôpital Morvan, Brest

30318

Piedmont Cancer Institute, PC, Atlanta

33081

IRCCS Centro di Riferimento Oncologico, Aviano

33901

Florida Cancer Specialists-Broadway, Fort Myers

34000

Oncobio Servicos de Saude, Nova Lima

34070

Clinique Clementville, Montpellier

34098

Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty, Istanbul

34147

Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital, Istanbul

34214

Medipol University Medical Faculty, Istanbul

34298

Institut Régional du Cancer de Montpellier, Montpellier

Institut Régional du Cancer de Montpellier, Montpellier

34732

Medical Park Goztepe Hospital, Istanbul

34854

Istanbul Medeniyet Uni Goztepe Training & Research Hospital, Istanbul

34890

Kartal Lutfi Kirdar Research and Training Hospital, Istanbul

35042

CRLCC Eugene Marquis, Rennes

35128

IOV - Istituto Oncologico Veneto IRCCS, Padua

35530

Izmir Medicalpark Hospital, Izmir

37024

Ospedale Sacro Cuore Don Calabria, Negrar

37203

SCRI - Tennessee Oncology, Nashville

37370

Hospital Universitario de Salamanca, Salamanca

37404

Tennessee Oncology, PLLC Chattanooga, Chattanooga

38138

The West Clinic, Germantown

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

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen del Rocio, Seville

41124

A.O.U. Policlinico di Modena, Modena

41404

Kyungpook National University Chilgok Hospital, Daegu

42080

Konya Necmettin Erbakan University Meram Faculty of Medicine, Konya

43100

Azienda Ospedaliero Universitaria di Parma, Parma

43235

The Ohio State University, Columbus

44124

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna, Cona

44195

Cleveland Clinic Main Campus, Cleveland

45267

University of Cincinnati Medical Center, Cincinnati

45409

Dayton Physicians, LLC, Kettering

46009

Instituto Valenciano de Oncologia IVO, Valencia

46236

Marienhospital Bottrop gGmbH, Bottrop

46321

Community Hospital, Munster

48149

Universitaetsklinikum Muenster, Müenster

48202

Henry Ford Hospital, Detroit

49100

Rabin Medical Center-Beilinson Campus, Petah Tikva

50009

Hospital Universitario Miguel Servet, Zaragoza

51067

Kliniken Koeln, Cologne

52363

Chaim Sheba Medical Center, Ramat Gan

53840

Haematologisch-Onkologische Schwerpunktpraxis, Troisdorf

54187

Sakarya Traning and Research Hospital, Sakarya

54645

Euromedica General Clinic Thessaloniki, Thessaloniki

55200

Medical Park Samsun Hastanesi, Samsun

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

59020

Centre Oscar Lambret, Lille

59100

Namik Kemal University, Tekirdağ

59300

Centre de cancerologie les Dentellieres, Valenciennes

60153

Loyola University Health System, Maywood

63110

Washington University, St Louis

64109

Centre Hospitalier de la côte Basque, Bayonne

64111

Saint Luke's Cancer Institute, Kansas City

64132

Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC, Kansas City

64804

Cornell-Beshore Cancer Institute, Joplin

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

71110

University General Hospital of Heraklion, Heraklion

72015

Clinique Victor Hugo - Centre Jean Bernard, Le Mans

75005

Institut Curie - site de Paris, Paris

Institut Curie - site de Paris, Paris

75020

Hopital Tenon, Paris

75390

UT Southwestern Medical Center, Dallas

75708

The University of Texas Health Science Center at Tyler, Tyler

76038

Centre Henri Becquerel, Rouen

77030

MD Anderson Cancer Center, Houston

The Methodist Hospital Research Institute, Houston

80131

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

81377

Klinikum der Universitaet Muenchen - Campus Grosshardern, Munich

81675

Klinikum rechts der Isar der TU Muenchen, Munich

84405

Community Cancer Trials of Utah, Ogden

84918

Institut Sainte Catherine, Avignon

85224

Ironwood Cancer Research Centers, Chandler

90095

UCLA Hematology Oncology - Main Site, Los Angeles

90603

Innovative Clinical Research Institute, Whittier

91054

Universitaetsklinikum Erlangen, Erlangen

92110

Centre René Huguenin, Saint-Cloud

92123

Sharp Memorial Hospital, San Diego

92160

Hôpital Privé d'Antony, Antony

93940

Pacific Cancer Care, Monterey

94805

Institut Gustave Roussy, Villejuif

96826

Kapiolani Medical Center for Women and Children/Univ of HI, Honolulu

98158

Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte, Messina

98405

MultiCare Health System Institute for Research and Innovation, Tacoma

3109601

Rambam Health Care Center, Haifa

4428164

Sapir Medical Center, Meir Hospital, Kfar Saba

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

9103102

Shaare Zedek Medical Center, Jerusalem

9112001

Hadassah University Hospital - Ein Kerem, Jerusalem

06510

Smilow Cancer Hospital at Yale New Haven, New Haven

04074

Maine Center for Cancer Medicine, Scarborough

02215

Beth Israel Deaconess Medical Center, Boston

Dana Farber Cancer Institute, Boston

60810-180

Pronutrir, Fortaleza

40170-110

NOB - Núcleo de Oncologia da Bahia, Salvador

41950-640

AMO - Assistência Multidisciplinar em Oncologia, Salvador

90110-270

HGB - Hospital Giovanni Battista - Mãe de Deus Center, Porto Alegre

90430-090

CliniOnco - Tratamento Integrado do Câncer, Porto Alegre

90610-000

Escosteguy Barrios, Carlos Henrique, Porto Alegre

91350-200

Hospital Nossa Senhora da Conceição, Porto Alegre

88301-220

Clínica de Neoplasias Litoral Ltda., Itajaí

09060-650

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

03102-002

IBCC - Instituto Brasileiro de Controle do Câncer, São Paulo

22793-080

COI - Clínicas Oncológicas Integradas, Rio de Janeiro

01308

Sociedade Beneficiente de Senhoras Hospital Sírio Libanês, São Paulo

01509-900

A. C. Camargo Cancer Center, São Paulo

625 00

Fakultni nemocnice Brno, Brno

775 20

Fakultni nemocnice Olomouc, Olomouc

150 06

Fakultni nemocnice v Motole, Prague

180 81

Nemocnice Na Bulovce, Prague

04103

Universitaetsklinikum Leipzig AoeR, Leipzig

960-1295

Fukushima Medical University Hospital, Fukushima

589-8511

Kindai University Hospital, Osakasayama-shi

Kindai University Hospital, Ōsakasayama-shi

104-0045

National Cancer Center Hospital, Chūōku

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

663-8501

Hyōgo College of Medicine Hospital, Hyōgo

216-8511

St. Marianna University School of Medicine Hospital, Kanagawa

241-8515

Kanagawa Cancer Center, Kanagawa

606-8507

Kyoto University Hospital, Kyoto

980-8574

Tohoku University Hospital, Miyagi

464-8681

Aichi Cancer Center Hospital, Nagoya

951-8566

Niigata Cancer Center Hospital, 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

105-8470

Toranomon Hospital, Tokyo

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

160-0023

Tokyo Medical University Hospital, Tokyo

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03772

Severance Hospital, Yonsei University, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

08916

ICO Badalona - Hospital Universitari Germans Trias i Pujol, Badalona

08908

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

06007

Hospital Infanta Cristina, Badajoz

08023

Hospital Quironsalud Barcelona, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

01130

Acibadem Adana Hospital, Adana

01370

Adana Numune Training and Research Hospital, Adana

07058

Akdeniz University Medical Faculty, Antalya

TR1 3LJ

Royal Cornwall Hospital, Truro

EX2 5DW

Royal Devon and Exeter Hospital (Wonford), Exeter

PL6 8BQ

Derriford Hospital, Plymouth

AB25 2ZB

Aberdeen Royal Infirmary, Aberdeen

EC1M 6BQ

Queen Mary University of London, London

NW1 2PG

University College London Hospitals, London

W1G 6AD

Sarah Cannon Research Institute UK, London

EH4 2XU

Western General Hospital, Edinburgh

NG5 1PB

Nottingham University Hospitals City Campus, Nottingham

Sponsors
All Listed Sponsors
collaborator

Daiichi Sankyo Co., Ltd.

INDUSTRY

collaborator

AstraZeneca

INDUSTRY

lead

Daiichi Sankyo

INDUSTRY