A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

732

Participants

Timeline

Start Date

October 18, 2021

Primary Completion Date

July 24, 2024

Study Completion Date

December 31, 2025

Conditions
Breast Cancer
Interventions
DRUG

Dato-DXd

Experimental drug. Provided in 100mg vials. IV infusion.

DRUG

Capecitabine

Tablet. Oral route of administration. Active comparator

DRUG

Gemcitabine

IV Infusion. Active comparator

DRUG

Eribulin

IV Infusion. Active comparator

DRUG

Vinorelbine

IV Infusion. Active comparator

Trial Locations (167)

333

Research Site, Taoyuan District

833

Research Site, Kaohsiung City

1062

Research Site, Budapest

1070

Research Site, Anderlecht

1122

Research Site, Budapest

1414

Research Site, CABA

1900

Research Site, La Plata

2000

Research Site, Rosario

2013

Research Site, Johannesburg

2123

Research Site, Rosario

2196

Research Site, Johannesburg

3000

Research Site, Leuven

4000

Research Site, Liège

4103

Research Site, Leipzig

5000

Research Site, Szolnok

6045

Research Site, Port Elizabeth

6273

Research Site, Seoul

6529

Research Site, George

7100

Research Site, Szekszárd

7600

Research Site, Mar del Plata

8036

Research Site, Barcelona

10050

Research Site, Taipei

10060

Research Site, Candiolo

10065

Research Site, New York

10408

Research Site, Goyang-si

10449

Research Site, Taipei

11217

Research Site, Taipei

15006

Research Site, A Coruña

20132

Research Site, Milan

20141

Research Site, Milan

21005

Research Site, Huelva

22190

Research Site, Plérin

23219

Research Site, Richmond

28034

Research Site, Madrid

28040

Research Site, Madrid

29010

Research Site, Málaga

30322

Research Site, Atlanta

31059

Research Site, Toulouse

32207

Research Site, Jacksonville

33030

Research Site, Bordeaux

34070

Research Site, Montpellier

35128

Research Site, Padua

37203

Research Site, Nashville

40138

Research Site, Bologna

40447

Research Site, Taichung

41013

Research Site, Seville

44119

Research Site, Cleveland

46010

Research Site, Valencia

47014

Research Site, Meldola

48013

Research Site, Bilbao (Vizcaya)

49503

Research Site, Grand Rapids

50139

Research Site, Florence

51430

Research Site, Bezannes

59000

Research Site, Lille

59100

Research Site, Prato

66421

Research Site, Homburg

69008

Research Site, Lyon

69120

Research Site, Heidelberg

70403

Research Site, Tainan City

80131

Research Site, Napoli

80637

Research Site, München

82445

Research Site, Kaohsiung City

88212

Research Site, Ravensburg

90095

Research Site, Los Angeles

91010

Research Site, Duarte

94143

Research Site, San Francisco

94800

Research Site, Villejuif

97239

Research Site, Portland

100044

Research Site, Beijing

100071

Research Site, Beijing

100210

Research Site, Beijing

115478

Research Site, Moscow

122001

Research Site, Gūrgaon

130021

Research Site, Changchun

143423

Research Site, Moscow

150049

Research Site, Harbin

200000

Research Site, Shanghai

233060

Research Site, Bengbu

250001

Research Site, Jinan

250117

Research Site, Jinan

276000

Research Site, Linyi

300060

Research Site, Tianjin

302022

Research Site, Jaipur

310003

Research Site, Hangzhou

310020

Research Site, Hangzhou

310022

Research Site, Hangzhou

330006

Research Site, Nanchang

330009

Research Site, Nanchang

361003

Research Site, Xiamen

395002

Research Site, Surat

410013

Research Site, Changsha

422009

Research Site, Nashik

500084

Research Site, Hyderabad

510060

Research Site, Guangzhou

530017

Research Site, Visakhapatnam

610000

Research Site, Chengdu

700160

Research Site, Kolkata

711103

Research Site, Howrah

1323001

Research Site, São Paulo

90035903

Research Site, Porto Alegre

94305-5826

Research Site, Palo Alto

02114

Research Site, Boston

02215

Research Site, Boston

C1280AEB

Research Site, CABA

88301-220

Research Site, Itajaí

17210-070

Research Site, Jaú

14051-140

Research Site, Ribeirão Preto

20560-120

Research Site, Rio de Janeiro

01236-030

Research Site, São Paulo

01246-000

Research Site, São Paulo

01509-900

Research Site, São Paulo

M2K 1E1

Research Site, North York

M5G 2M9

Research Site, Toronto

H3T 1E2

Research Site, Montreal

H4A 3J1

Research Site, Montreal

G1S 4L8

Research Site, Québec

071000

Research Site, Baoding

00168

Research Site, Roma

104-0045

Research Site, Chūōku

811-1395

Research Site, Fukuoka

960-1295

Research Site, Fukushima

730-8518

Research Site, Hiroshima

259-1193

Research Site, Isehara-shi

892-0833

Research Site, Kagoshima

227-8577

Research Site, Kashiwa

362-0806

Research Site, Kitaadachi-gun

135-8550

Research Site, Kōtoku

606-8507

Research Site, Kyoto

791-0280

Research Site, Matsuyama

464-8681

Research Site, Nagoya

663-8501

Research Site, Nishinomiya-shi

541-8567

Research Site, Osaka

589-8511

Research Site, Osakasayama-shi

003-0804

Research Site, Sapporo

142-8666

Research Site, Shinagawa-ku

162-8655

Research Site, Shinjuku-ku

241-8515

Research Site, Yokohama

1081 HV

Research Site, Amsterdam

3083 AN

Research Site, Rotterdam

5912 BL

Research Site, Venlo

15-027

Research Site, Bialystok

80-952

Research Site, Gdansk

81-519

Research Site, Gdynia

62-500

Research Site, Konin

75-581

Research Site, Koszalin

90-302

Research Site, Lodz

97-200

Research Site, Tomaszów Mazowiecki

02-781

Research Site, Warsaw

0081

Research Site, Pretoria

02841

Research Site, Seoul

03080

Research Site, Seoul

03722

Research Site, Seoul

05505

Research Site, Seoul

06351

Research Site, Seoul

08028

Research Site, Barcelona

08908

Research Site, L'Hospitalet de Llobregat

FY3 8NR

Research Site, Blackpool

BS2 8ED

Research Site, Bristol

CF14 2TL

Research Site, Cardiff

CO4 5JL

Research Site, Colchester

EH4 2XU

Research Site, Edinburgh

EC1A 7BE

Research Site, London

SW3 6JJ

Research Site, London

M20 4BX

Research Site, Manchester

NG5 1PB

Research Site, Nottingham

SM2 5PT

Research Site, Sutton

TR1 3LJ

Research Site, Truro

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Daiichi Sankyo

INDUSTRY

lead

AstraZeneca

INDUSTRY