A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)

PHASE2TerminatedINTERVENTIONAL
Enrollment

253

Participants

Timeline

Start Date

August 25, 2017

Primary Completion Date

March 21, 2019

Study Completion Date

May 6, 2024

Conditions
Breast Cancer
Interventions
DRUG

DS-8201a

DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as low, medium and high intravenous (IV) doses for Part 1 of the trial. The dose for Part 2 will be determined based on results from Part 1.

Trial Locations (99)

2800

AZ Sint-Maarten, Mechelen

2820

Imeldaziekenhuis, Bonheiden

3000

UZ Leuven, Leuven

4000

CHU Sart Tilman, Liège

6000

Grand Hôpital de Charleroi, Charleroi

6080

Hospital Infanta Cristina, Badajoz

8023

Hospital Quiron Barcelona, Barcelona

10065

Memorial Sloan Kettering Cancer Center, New York

10408

National Cancer Center, Goyang-si

11733

North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood Specialists, East Setauket

13620

Seoul National University Bundang Hospital, Seongnam-si

13915

Hôpital Nord - CHU Marseille, Marseille

15212

Allegheny General Hospital, Pittsburgh

15232

UPMC Cancer Center, Pittsburgh

17019

CH de la Rochelle - Hopital St Louis, La Rochelle

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

22031

Virginia Cancer Specialists, PC, Fairfax

25030

CHU Besançon - Hôpital Jean Minjoz, Besançon

28033

MD Anderson Cancer Centre, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28046

Hospital Universitario La Paz, Madrid

29010

Hospital Clinico Universitario Virgen de la Victoria, Málaga

29601

St Francis Hospital, Greenville

30318

Piedmont Cancer Institute, Atlanta

33012

Specialist Global Research, Hialeah

33075

CHU Bordeaux - Hôpital Saint André, Gironde

33176

Miami Cancer Institute at Baptist Health, Inc., Miami

33426

Sylvester Comprehensive Cancer Center - Deerfield Beach, Boca Raton

34298

Institut Régional du Cancer de Montpellier, Montpellier

35042

CRLCC Eugene Marquis, Rennes

40202

Norton Healthcare, Louisville

University of Louisville Research Foundation, Louisville

41009

Hospital Universitario Virgen Macarena, Seville

41404

Kyungpook National University Chilgok Hospital, Daegu

44202

Centre Catherine de Sienne, Nantes

44710

Aultman Hospital Cancer Center, Canton

45267

University of Cincinnati Medical Center, Cincinnati

46009

Instituto Valenciano de Oncologia IVO, Valencia

47923

Ospedale degli Infermi, Rimini

48202

Henry Ford Hospital, Detroit

60020

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette

63110

Washington University School of Medicine, St Louis

67000

Centre Paul Strauss, Strasbourg

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70120

Ochsner Clinic Foundation, New Orleans

72015

Clinique Victor Hugo - Centre Jean Bernard, Le Mans

75246

Texas Oncology, P.A., Dallas

75475

Hôpital Saint-Louis - Paris, Paris

75702

Texas Oncology, P.A. - Longview, Tyler

75708

The University of Texas Health Science Center at Tyler, Tyler

77024

Texas Oncology - Memorial City, Houston

77030

MD Anderson Cancer Center, Houston

The Methodist Hospital Research Institute, Houston

77521

Accurate Clinical Research, Baytown

84918

Institut Sainte Catherine, Avignon

85704

Arizona Oncology Associates, Tucson

90095

The Regents of the University of California, Los Angeles

90603

Innovative Clinical Research Institute, LLC, Whittier

92123

Sharp Clinical Oncology Research, San Diego

93105

Sansum Clinic, Santa Barbara

94115

University of California San Francisco, San Francisco

94160

Hôpital d'Instruction des Armees Begin, Saint-Mandé

94805

Institut Gustave Roussy, Villejuif

96813

Straub Medical Center, Honolulu

University of Hawaii, Honolulu

98201

Providence Regional Medical Center - Everett, Everett

99508

Alaska Urological Institute dba Alaska Clinical Research Center, Anchorage

02215

Beth Israel Deaconess Medical Center, Boston

Dana Farber Cancer Institute, Boston

T2N 4N2

University of Calgary, Calgary

791-0280

NHO Shikoku Cancer Center, Matsuyama

105-8470

Toranomon Hospital, Minatoku

464-8681

Aichi Cancer Center Hospital, Aichi

277-8577

National Cancer Center Hospital East, Chiba

811-1395

NHO Kyushu Cancer Center, Fukuoka

892-0833

Hakuaikai Sagara Hospital, Kagoshima

241-0815

Kanagawa Cancer Center, Kanagawa

589-8511

Kindai University Hospital, Osaka

104-0045

National Cancer Center Hospital, Tokyo

104-8560

St. Luke's International Hospital, Tokyo

135-8550

Cancer Institute Hospital of JFCR, Tokyo

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08028

Hospital Universitari Quiron Dexeus, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08908

ICO l´Hospitalet - Hospital Duran i Reynals, Barcelona

PL6 8BQ

Derriford Hospital, Plymouth

EC1M 6BQ

Queen Mary University of London, London

NW1 2PG

University College London Hospitals, 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

AstraZeneca

INDUSTRY

collaborator

Daiichi Sankyo Co., Ltd.

INDUSTRY

lead

Daiichi Sankyo

INDUSTRY