Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

557

Participants

Timeline

Start Date

December 27, 2018

Primary Completion Date

January 11, 2022

Study Completion Date

August 1, 2026

Conditions
Breast Cancer
Interventions
DRUG

Trastuzumab deruxtecan (DS-8201a)

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

DRUG

Capecitabine

Administered according to label, as one option for Physician's Choice (determined before randomization)

DRUG

Eribulin

Administered according to label, as one option for Physician's Choice (determined before randomization)

DRUG

Gemcitabine

Administered according to label, as one option for Physician's Choice (determined before randomization)

DRUG

Paclitaxel

Administered according to label, as one option for Physician's Choice (determined before randomization)

DRUG

Nab-paclitaxel

Administered according to label, as one option for Physician's Choice (determined before randomization)

Trial Locations (208)

100

National Taiwan University Hospital, Taipei

704

National Cheng Kung University Hospital, Tainan City

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1000

Institut Jules Bordet, Brussels

1011

Centre Hospitalier Universitaire Vaudois, Lausanne

1090

AKH - Medizinische Universität Wien (4305), Vienna

Universitair Ziekenhuis Brussel, Brussels

1097

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Budapest

1122

Orszagos Onkologiai Intezet, Budapest

1200

Cliniques Universitaires Saint-Luc, Brussels

3000

UZ Leuven, Leuven

4020

Kepler Universitätsklinikum, Linz

4031

Universitaetsspital Basel, Basel

4032

Debreceni Egyetem, Debrecen

4400

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza

4600

Klinikum Wels-Grieskirchen GmbH, Wels

5000

CHU UCL Namur, Namur

Hirslanden Medical Center, Aarau

5004

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok

5020

LKH - Universitätsklinikum der PMU Salzburg, Salzburg

5700

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Gyula

6020

Medizinische Universität Innsbruck, Innsbruck

6280

Grand Hôpital de Charleroi, Loverval

7000

Kantonsspital Graubuenden, Chur

7500

Centre Hospitalier Wallonie picarde - Site IMC, Tournai

8091

Universitaetsspital Zuerich, Zurich

8401

Kantonsspital Winterthur, Winterthur

9007

Kantonsspital St. Gallen, Sankt Gallen

10016

New York University Medical Center, New York

10065

Memorial Sloan Kettering Hospital, New York

Weill Cornell Medicine Breast Center, New York

10408

National Cancer Center, Goyang-si

11528

"General Hospital of Athens Alexandra", Athens

13009

Institut Paoli Calmettes, Marseille

13100

Ziv Medical Center, Safed

13620

Seoul National University Bundang Hospital, Seongnam-si

14076

Centre François Baclesse, Caen

14564

"General Oncology Hospital of Kifissia Agioi Anargyroi", Athens

15006

Complejo Hospitalario Universitario A Coruña, A Coruña

15125

Athens Medical Center, Athens

15212

Allegheny General Hospital, Pittsburgh

15219

University of Pittsburgh Medical Center Health System, Pittsburgh

16499

Ajou University Hospital, Suwon

17176

Karolinska universitetssjukhuset - Solna, Solna

19713

Christiana Care Health Services, Inc., Newark

20014

Hospital Universitario Donostia, San Sebastián

20032

Fudan University Shanghai Cancer Center, Shanghai

20089

Istituto Clinico Humanitas, Rozzano

20141

IEO Istituto Europeo di Oncologia, Milan

20900

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

22031

Virginia Cancer Specialists, Fairfax

22190

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

22332

Inha University Hospital, Incheon

25100

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili), Brescia

28033

MD Anderson Cancer Centre, Madrid

28034

Hospital Ruber Internacional, Madrid

Hospital Universitario Ramon y Cajal, Madrid

28040

Hospital Universitario Clinico San Carlos, Madrid

29010

Hospital Clinico Universitario Virgen de la Victoria, Málaga

29601

St Francis Hospital, Greenville

29609

CHU Brest - Hôpital Morvan, Brest

30263

Cancer Treatment Centers of America-Georgia, Newnan

32806

Orlando Health, Inc., Orlando

33021

Memorial Healthcare System MRH Cancer Center, Hollywood

33076

Institut Bergonié, Bordeaux

33139

Moffitt Cancer Center -Tampa, Tampa

33426

Sylvester Comprehensive Cancer Center - Deerfield Beach, Boca Raton

33916

Florida Cancer Specialists (South Region), Fort Myers

34070

Clinique Clementville, Montpellier

34298

Institut Régional du Cancer de Montpellier, Montpellier

35042

CRLCC Eugene Marquis, Rennes

37024

Ospedale Sacro Cuore Don Calabria, Negrar

37201

Tennessee Oncology - Skyline Satellite, Nashville

37909

Brig Center for Cancer Care and Survivorship, Knoxville

38120

Baptist Cancer Center, Memphis

38320

Hospital Universitario de Canarias, San Cristóbal de La Laguna

40138

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen del Rocio, Seville

41110

University General Hospital of Larissa, Larissa

41404

Kyungpook National University Chilgok Hospital, Daegu

43012

Centre Hospitalier Emile Roux, Le Puy-en-Velay

44195

The Cleveland Clinic Foundation, Cleveland

44805

ICO - Site René Gauducheau, Saint-Herblain

46009

Instituto Valenciano de Oncologia IVO, Valencia

46014

Hospital General Universitario de Valencia, Valencia

47923

Ospedale degli Infermi, Rimini

48013

Hospital de Basurto, Bilbao

48202

Henry Ford Hospital, Detroit

49055

ICO - Site Paul Papin, Angers

49100

Rabin Medical Center-Beilinson Campus, Petah Tikva

52363

Chaim Sheba Medical Center, Ramat Gan

54622

Bioclinic Thessaloniki, Thessaloniki

54645

Euromedica General Clinic Thessaloniki, Thessaloniki

56429

General Hospital Papageorgiou, Thessaloniki

57001

Interbalkan Hospital of Thessaloniki, Thessaloniki

59322

Centre Hospitalier Valenciennes, Valenciennes

60099

Cancer Treatment Centers of America, Zion

60637

University of Chicago Medical Center, Chicago

64111

Saint Luke's Hospital of Kansas City, Kansas City

67214

Cancer Center of Kansas, Wichita

69120

Universitaetsklinikum Heidelberg, Heidelberg

70115

Touro Infirmary, New Orleans

71110

University General Hospital of Heraklion, Heraklion

72015

Clinique Victor Hugo - Centre Jean Bernard, Le Mans

73039

Azienda Ospedaliera Card. G. Panico, Tricase

75005

Institut Curie - site de Paris, Paris

75020

Hopital Tenon, Paris

75185

Akademiska Sjukhuset, Uppsala

75234

BloomTrials Clinical Research, LLC, Dallas

75475

Hôpital Saint-Louis - Paris, Paris

77030

The Methodist Hospital Research Institute, Houston

University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics, Houston

80131

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

81377

Klinikum der Universitaet Muenchen - Campus Grosshardern, Munich

84918

Institut Sainte Catherine, Avignon

85186

Länssjukhuset Sundsvall-Härnösand, Sundsvall

85224

Ironwood Cancer & Research Centers - Chandler II, Chandler

85234

Banner MD Anderson Cancer Center, Gilbert

85338

Cancer Treatment Centers of America at Western Regional Medical Center, Goodyear

88100

Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario, Catanzaro

90095

UCLA School of Medicine, Los Angeles

90277

Cancer Care Associates Medical Group, Inc. TORI, Redondo Beach

94158

University of California at San Francisco (PARENT), San Francisco

94160

Hôpital d'Instruction des Armees Begin*, Saint-Mandé

94305

Stanford Cancer Institute, Palo Alto

94805

Institut Gustave Roussy, Villejuif

95125

Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico, Catania

97239

Oregon Health & Science University, Portland

100021

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

100853

Chinese PLA General Hospital, Beijing

110042

Liaoning Cancer Hospital & Institute, Shenyang

115478

"FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow

130000

The First Hospital of Jilin University, Changchun

130012

Jilin Cancer Hospital, Changchun

143423

"SBIH of Moscow City Moscow City Oncology Hospital №62 of Moscow Healthcare Departement", Moscow

150054

"SBIH of Yaroslavl Region Regional Clinical Oncological Hospital", Yaroslavl

150081

Harbin Medical University Cancer Hospital, Harbin

200080

Shanghai General Hospital, Shanghai

210008

The Affiliated Drum Tower Hospital of Nanjing University, Nanjing

230001

Anhui Provincial Hospital, Hefei

276001

Linyi Cancer Hospital, Linyi

310016

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

310022

Zhejiang Cancer Hospital, Hangzhou

350025

Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA, Fuzhou

430079

Hubei Cancer Hospital, Wuhan

510120

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

610041

West China Hospital, Sichuan University, Chengdu

750004

General Hospital of Ningxia Medical University, Yinchuan

3109601

Rambam Health Care Center, Haifa

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

7610001

Kaplan Medical Center, Rehovot

9103102

Shaare Zedek Medical Center, Jerusalem

9112001

Hadassah University Hospital - Ein Kerem, Jerusalem

06360

Eastern Connecticut Hematology/Oncology Assoc., Norwich

02215

Dana-Farber Cancer Institute, Boston

07039

Saint Barnabas Medical Center, Livingston

T2N4N2

Tom Baker Cancer Center, Calgary

M4N 3M5

Toronto Sunnybrook Hospital, Toronto

H2W 1S6

McGill University - Dept. Oncology Clinical Research Program, Montreal

00133

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Roma

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

464-8681

Aichi Cancer Center Hospital, Nagoya

277-8577

National Cancer Center Hospital East, Kashiwa-shi

791-0280

NHO Shikoku Cancer Center, Matsuyama

811-1395

NHO Kyushu Cancer Center, Fukuoka

960-1295

Fukushima Medical University Hospital, Fukushima

730-8518

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

003-0804

NHO Hokkaido Cancer Center, Sapporo

663-8501

Hyogo College of Medicine Hospital, Nishinomiya-shi

892-0833

Hakuaikai Sagara Hospital, Kagoshima

259-1193

Tokai University Hospital, Isehara

241-8515

Kanagawa Cancer Center, Yokohama

540-0006

NHO Osaka National Hospital, Osaka

589-8511

Kindai University Hospital, Onohigashi

362-0806

Saitama Cancer Center, Kitaadachi-gun

411-8777

Shizuoka Cancer Center, Sunto-gun

135-8550

Cancer Institute Hospital of JFCR, Kōtoku

105-8470

Toranomon Hospital, Minatoku

142-8666

Showa University Hospital, Shinagawa-Ku

4710-243

Hospital de Braga, Braga

4835-044

Centro Hospitalar do Alto do Ave, EPE, Guimarães

1400-038

Fundação Champalimaud, Lisbon

1649-035

Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisbon

4464-509

Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano), Matosinhos Municipality

4099-001

Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António, Porto

4200-072

Instituto Português de Oncologia do Porto Francisco Gentil, EPE, Porto

4520-211

Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião, Santa Maria da Feira

4434-502

Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E, Vila Nova de Gaia

5000-508

Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE, Vila Real

361-711

Chungbuk National University Hospital, Cheongju-si

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

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

120-752

Severance Hospital, Yonsei University Health System, Seoul

08908

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

08003

Hospital del Mar, Barcelona

08023

Hospital Quironsalud Barcelona, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

TR1 3LJ

Royal Cornwall Hospital, Truro

EC1M 6BQ

Queen Mary University of London, London

NW1 2PG

University College London Hospitals, London

NW3 2QG

Royal Free Hospital, London

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