A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

644

Participants

Timeline

Start Date

May 16, 2022

Primary Completion Date

December 3, 2025

Study Completion Date

December 3, 2025

Conditions
Breast Cancer
Interventions
DRUG

Dato-DXd

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

DRUG

Paclitaxel

IV Infusion. Active comparator

DRUG

Nab-paclitaxel

IV infusion. Active comparator

DRUG

Carboplatin

IV infusion. Active comparator

DRUG

Capecitabine

Tablet. Oral route of administration. Active comparator

DRUG

Eribulin mesylate

IV infusion. Active comparator

Trial Locations (227)

300

Research Site, Hsinchu

710

Research Site, Tainan City

1058

Research Site, Buenos Aires

1062

Research Site, Budapest

1070

Research Site, Anderlecht

1101

Research Site, Quezon City

1112

Research Site, Quezon City

1122

Research Site, Budapest

1414

Research Site, CABA

1426

Research Site, CABA

1500

Research Site, San Juan City

1780

Research Site, City of Muntinlupa

2000

Research Site, Rosario

2013

Research Site, Soweto

2196

Research Site, Johannesburg

2610

Research Site, Wilrijk

3526

Research Site, Miskolc

4400

Research Site, Nyíregyháza

5000

Research Site, Namur

Research Site, Iloilo City

6000

Research Site, Cebu

Research Site, Cebu City

6100

Research Site, Bacolod

6760

Research Site, México

7570

Research Site, Cape Town

8035

Research Site, Barcelona

8900

Research Site, Zalaegerszeg

9000

Research Site, Ghent

9100

Research Site, Sint-Niklaas

10002

Research Site, Taipei

10065

Research Site, New York

10210

Research Site, Bangkok

10300

Research Site, Dusit

10330

Research Site, Bangkok

10400

Research Site, Bangkok

11217

Research Site, Taipei

13273

Research Site, Marseille

14080

Research Site, México

15706

Research Site, Santiago de Compostela

16132

Research Site, Genova

18016

Research Site, Granada

20010

Research Site, Washington D.C.

20089

Research Site, Rozzano

20132

Research Site, Milan

20141

Research Site, Milan

21079

Research Site, Dijon

21280

Research Site, Diyarbakır

22908

Research Site, Charlottesville

27103

Research Site, Winston-Salem

28007

Research Site, Madrid

28034

Research Site, Madrid

28046

Research Site, Madrid

28204

Research Site, Charlotte

28222

Research Site, Majadahonda

29010

Research Site, Málaga

30322

Research Site, Atlanta

30625

Research Site, Hanover

33076

Research Site, Bordeaux

33170

Research Site, Miami

33176

Research Site, Miami

34298

Research Site, Montpellier

34662

Research Site, Istanbul

35575

Research Site, Izmir

37000

Research Site, Tours

37203

Research Site, Nashville

38120

Research Site, Memphis

40002

Research Site, Khon Kaen

40207

Research Site, Louisville

40447

Research Site, Taichung

40705

Research Site, Taichung

41013

Research Site, Seville

41124

Research Site, Modena

41404

Research Site, Daegu

42080

Research Site, Konya

44280

Research Site, Guadalajara Jalisco

Research Site, Malatya

44670

Research Site, Guadalajara

44805

Research Site, Saint-Herblain

48149

Research Site, Münster

48201

Research Site, Detroit

49124

Research Site, Georgsmarienhütte

50032

Research Site, Borgo San Lorenzo

50200

Research Site, Chiang Mai

53111

Research Site, Bonn

53792

Research Site, Madison

56068

Research Site, Koblenz Am Rhein

57105

Research Site, Sioux Falls

57126

Research Site, Livorno

60431

Research Site, Frankfurt am Main

62100

Research Site, Macerata

63225

Research Site, Langen

63739

Research Site, Aschaffenburg

65199

Research Site, Wiesbaden

69373

Research Site, Lyon

70403

Research Site, Tainan City

74078

Research Site, Heilbronn

75010

Research Site, Paris

76021

Research Site, Rouen

76104

Research Site, Fort Worth

77030

Research Site, Houston

77339

Research Site, Kingwood

78240

Research Site, San Antonio

80131

Research Site, Napoli

80504

Research Site, Longmont

81377

Research Site, München

81501

Research Site, Grand Junction

87042

Research Site, Limoges

87109

Research Site, Albuquerque

88100

Research Site, Catanzaro

90017

Research Site, Los Angeles

90110

Research Site, Hat Yai

91010

Research Site, Duarte

94143

Research Site, San Francisco

99216

Research Site, Spokane Valley

100021

Research Site, Beijing

100039

Research Site, Beijing

100044

Research Site, Beijing

110042

Research Site, Shenyang

110085

Research Site, New Delhi

119074

Research Site, Singapore

130021

Research Site, Changchun

169610

Research Site, Bukit Merah

200025

Research Site, Shanghai

200032

Research Site, Shanghai

210036

Research Site, Nanjing

230031

Research Site, Hefei

230601

Research Site, Hefei

233004

Research Site, Bengbu

250001

Research Site, Jinan

300060

Research Site, Tianjin

302022

Research Site, Jaipur

308433

Research Site, Singapore

310003

Research Site, Hangzhou

310009

Research Site, Hangzhou

310022

Research Site, Hangzhou

330009

Research Site, Nanchang

391760

Research Site, Vadodara

400016

Research Site, Chongqing

410008

Research Site, Changsha

410013

Research Site, Changsha

422009

Research Site, Nashik

440001

Research Site, Nagpur

450008

Research Site, Zhengzhou

450052

Research Site, Zhengzhou

510060

Research Site, Guangzhou

510100

Research Site, Guangzhou

518029

Research Site, Shenzhen

560004

Research Site, Bangalore

605006

Research Site, Puducherry

610000

Research Site, Chengdu

700160

Research Site, Kolkata

710004

Research Site, Xi'an

710100

Research Site, Xi'an

2501117

Research Site, Jinan

06510

Research Site, New Haven

02903

Research Site, Providence

C1125ABD

Research Site, Buenos Aires

C1430EFA

Research Site, Ciudad Autónoma Buenos Aires

B7600

Research Site, Mar del Plata

71681-603

Research Site, Brasília

80440-220

Research Site, Curitiba

74000-000

Research Site, Goiânia

17210-120

Research Site, Jaú

90619-900

Research Site, Porto Alegre

91350-200

Research Site, Porto Alegre

20560-120

Research Site, Rio de Janeiro

01246-000

Research Site, São Paulo

01321-001

Research Site, São Paulo

01409-001

Research Site, São Paulo

T2N 5G2

Research Site, Calgary

L4M 6M2

Research Site, Barrie

L8V 5C2

Research Site, Hamilton

K1H 8L6

Research Site, Ottawa

M5G 2M9

Research Site, Toronto

J4V 2H1

Research Site, Greenfield Park

H4A 3J1

Research Site, Montreal

G1S 4L8

Research Site, Québec

00137

Research Site, Roma

104-0045

Research Site, Chūōku

960-1295

Research Site, Fukushima

730-8518

Research Site, Hiroshima

259-1193

Research Site, Isehara-shi

892-0833

Research Site, Kagoshima

277-8577

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

466-8560

Research Site, Nagoya

951-8566

Research Site, Niigata

663-8501

Research Site, Nishinomiya-shi

980-8574

Research Site, Sendai

142-8666

Research Site, Shinagawa-ku

162-8655

Research Site, Shinjuku-ku

305-8577

Research Site, Tsukuba

241-8515

Research Site, Yokohama

04980

Research Site, CD Mexico

0 3100

Research Site, Mexico City

15-027

Research Site, Bialystok

85-796

Research Site, Bydgoszcz

93-338

Research Site, Lodz

60-185

Research Site, Skórzewo

02-781

Research Site, Warsaw

53-413

Research Site, Wroclaw

0002

Research Site, Pretoria

0081

Research Site, Pretoria

602-739

Research Site, Busan

03080

Research Site, Seoul

03722

Research Site, Seoul

05505

Research Site, Seoul

06273

Research Site, Seoul

06351

Research Site, Seoul

08028

Research Site, Barcelona

08908

Research Site, L'Hospitalet de Llobregat

00333

Research Site, Taoyuan District

06340

Research Site, Ankara

06520

Research Site, Ankara

BS2 8ED

Research Site, Bristol

CF14 2TL

Research Site, Cardiff

EH4 2XU

Research Site, Edinburgh

EC1A 7BE

Research Site, London

SE1 9RT

Research Site, London

SW17 0QT

Research Site, London

NN1 5BD

Research Site, Northampton

NG5 1PB

Research Site, Nottingham

CV34 5BW

Research Site, Warwick

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Daiichi Sankyo

INDUSTRY

lead

AstraZeneca

INDUSTRY