A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

625

Participants

Timeline

Start Date

November 23, 2023

Primary Completion Date

October 31, 2026

Study Completion Date

April 30, 2029

Conditions
Breast Cancer
Interventions
DRUG

Dato-DXd

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

DRUG

Durvalumab

Provided in 500mg vials. IV infusion. Experimental drug.

DRUG

Paclitaxel

IV infusion. Active comparator.

DRUG

Nab-paclitaxel

IV infusion. Active comparator.

DRUG

Gemcitabine

IV infusion. Active comparator.

DRUG

Carboplatin

IV infusion. Active comparator.

DRUG

Pembrolizumab

IV infusion. Active comparator.

Trial Locations (308)

100

RECRUITING

Research Site, Taipei

300

RECRUITING

Research Site, Hsinchu

333

RECRUITING

Research Site, Taoyuan District

704

RECRUITING

Research Site, Tainan City

1000

RECRUITING

Research Site, Manila

1112

RECRUITING

Research Site, Quezon City

1414

RECRUITING

Research Site, CABA

1425

RECRUITING

Research Site, CABA

1502

RECRUITING

Research Site, San Juan City

1780

RECRUITING

Research Site, City of Muntinlupa

2000

RECRUITING

Research Site, Rosario

2010

RECRUITING

Research Site, Darlinghurst

2013

RECRUITING

Research Site, Johannesburg

2050

RECRUITING

Research Site, Camperdown

2193

RECRUITING

Research Site, Johannesburg

2196

RECRUITING

Research Site, Johannesburg

2298

RECRUITING

Research Site, Waratah

3000

RECRUITING

Research Site, Melbourne

3084

RECRUITING

Research Site, Heidelberg

6000

RECRUITING

Research Site, Cebu City

6009

RECRUITING

Research Site, Nedlands

6100

RECRUITING

Research Site, Bacolod

6200

RECRUITING

Research Site, Ankara

6760

RECRUITING

Research Site, México

7570

RECRUITING

Research Site, Cape Town

7646

RECRUITING

Research Site, Paarl

8035

RECRUITING

Research Site, Barcelona

10065

RECRUITING

Research Site, New York

10210

RECRUITING

Research Site, Bangkok

10300

RECRUITING

Research Site, Dusit

10330

RECRUITING

Research Site, Bangkok

10400

RECRUITING

Research Site, Bangkok

10408

RECRUITING

Research Site, Goyang-si

10449

RECRUITING

Research Site, Taipei

11029

RECRUITING

Research Site, New Delhi

11259

RECRUITING

Research Site, Taipei

12206

WITHDRAWN

Research Site, Albany

13620

RECRUITING

Research Site, Seongnam-si

17403

WITHDRAWN

Research Site, York

18016

RECRUITING

Research Site, Granada

20089

RECRUITING

Research Site, Rozzano

20132

RECRUITING

Research Site, Milan

20141

RECRUITING

Research Site, Milan

20357

WITHDRAWN

Research Site, Hamburg

21044

RECRUITING

Research Site, Columbia

21215

WITHDRAWN

Research Site, Baltimore

22031

RECRUITING

Research Site, Fairfax

22903

RECRUITING

Research Site, Charlottesville

23114

RECRUITING

Research Site, Midlothian

23502

RECRUITING

Research Site, Norfolk

24014

RECRUITING

Research Site, Roanoke

24127

NOT_YET_RECRUITING

Research Site, Bergamo

28007

RECRUITING

Research Site, Madrid

28034

WITHDRAWN

Research Site, Madrid

29090

NOT_YET_RECRUITING

Research Site, Tuxtla Gutiérrez

30318

SUSPENDED

Research Site, Atlanta

30625

WITHDRAWN

Research Site, Hanover

31008

RECRUITING

Research Site, Pamplona

31059

RECRUITING

Research Site, Toulouse

32256

RECRUITING

Research Site, Jacksonville

32909

WITHDRAWN

Research Site, Palm Bay

33176

RECRUITING

Research Site, Miami

33324

RECRUITING

Research Site, Plantation

34295

RECRUITING

Research Site, Küçükçekmece

34298

RECRUITING

Research Site, Montpellier

35000

NOT_YET_RECRUITING

Research Site, Việt Trì

35128

RECRUITING

Research Site, Padua

35575

WITHDRAWN

Research Site, Izmir

36526

RECRUITING

Research Site, Daphne

37203

RECRUITING

Research Site, Nashville

37404

RECRUITING

Research Site, Chattanooga

39008

RECRUITING

Research Site, Santander

39401

WITHDRAWN

Research Site, Hattiesburg

40002

RECRUITING

Research Site, Khon Kaen

40202

WITHDRAWN

Research Site, Louisville

40207

WITHDRAWN

Research Site, Louisville

40447

RECRUITING

Research Site, Taichung

40479

WITHDRAWN

Research Site, Düsseldorf

40503

WITHDRAWN

Research Site, Lexington

41124

WITHDRAWN

Research Site, Modena

41404

RECRUITING

Research Site, Daegu

42123

RECRUITING

Research Site, Reggio Emilia

44195

RECRUITING

Research Site, Cleveland

44638

NOT_YET_RECRUITING

Research Site, Guadalajara

44670

WITHDRAWN

Research Site, Guadalajara

44805

RECRUITING

Research Site, Saint-Herblain

45136

WITHDRAWN

Research Site, Essen

45219

RECRUITING

Research Site, Cincinnati

45245

RECRUITING

Research Site, Cincinnati

47150

WITHDRAWN

Research Site, New Albany

48201

RECRUITING

Research Site, Detroit

49124

WITHDRAWN

Research Site, Georgsmarienhütte

49241

COMPLETED

Research Site, Busan

49503

WITHDRAWN

Research Site, Grand Rapids

50053

RECRUITING

Research Site, Empoli

50200

RECRUITING

Research Site, Chiang Mai

50309

RECRUITING

Research Site, Des Moines

53792

WITHDRAWN

Research Site, Madison

54031

RECRUITING

Research Site, Xintai

54511

RECRUITING

Research Site, Vandœuvre-lès-Nancy

55109

RECRUITING

Research Site, Saint Paul

55200

RECRUITING

Research Site, Samsun

59000

RECRUITING

Research Site, Lille

60126

WITHDRAWN

Research Site, Elmhurst

60540

WITHDRAWN

Research Site, Naperville

60637

RECRUITING

Research Site, Chicago

62526

WITHDRAWN

Research Site, Decatur

63129

RECRUITING

Research Site, St Louis

69120

WITHDRAWN

Research Site, Heidelberg

69373

RECRUITING

Research Site, Lyon

70808

WITHDRAWN

Research Site, Baton Rouge

70809

RECRUITING

Research Site, Baton Rouge

72762

RECRUITING

Research Site, Springdale

74078

WITHDRAWN

Research Site, Heilbronn

75020

RECRUITING

Research Site, Paris

75028

WITHDRAWN

Research Site, Flower Mound

75071

WITHDRAWN

Research Site, McKinney

75230

WITHDRAWN

Research Site, Dallas

75246

RECRUITING

Research Site, Dallas

WITHDRAWN

Research Site, Dallas

76104

WITHDRAWN

Research Site, Fort Worth

77054

WITHDRAWN

Research Site, Houston

77090

WITHDRAWN

Research Site, Houston

77098

WITHDRAWN

Research Site, Houston

77339

WITHDRAWN

Research Site, Kingwood

77479

RECRUITING

Research Site, Sugar Land

79902

RECRUITING

Research Site, El Paso

80012

RECRUITING

Research Site, Aurora

80131

RECRUITING

Research Site, Napoli

80756

RECRUITING

Research Site, Kaohsiung City

87109

RECRUITING

Research Site, Albuquerque

90110

RECRUITING

Research Site, Songkhla

91010

WITHDRAWN

Research Site, Duarte

91204

RECRUITING

Research Site, Glendale

94800

RECRUITING

Research Site, Villejuif

95403

WITHDRAWN

Research Site, Santa Rosa

95817

RECRUITING

Research Site, Sacramento

96819

WITHDRAWN

Research Site, Honolulu

98405

RECRUITING

Research Site, Tacoma

100000

RECRUITING

Research Site, Hanoi

100044

RECRUITING

Research Site, Beijing

100142

RECRUITING

Research Site, Beijing

110004

RECRUITING

Research Site, Shenyang

110075

RECRUITING

Research Site, New Delhi

119228

WITHDRAWN

Research Site, Singapore

130021

RECRUITING

Research Site, Changchun

150081

RECRUITING

Research Site, Harbin

160055

RECRUITING

Research Site, Mohali

169610

RECRUITING

Research Site, Singapore

200025

RECRUITING

Research Site, Shanghai

200080

RECRUITING

Research Site, Shanghai

210009

RECRUITING

Research Site, Nanjing

217562

NOT_YET_RECRUITING

Research Site, Singapore

221009

RECRUITING

Research Site, Xuzhou

230031

RECRUITING

Research Site, Hefei

233004

RECRUITING

Research Site, Bengbu

250021

RECRUITING

Research Site, Jinan

300000

RECRUITING

Research Site, Tianjin

302004

NOT_YET_RECRUITING

Research Site, Jaipur

RECRUITING

Research Site, Marg Jaipur

308433

NOT_YET_RECRUITING

Research Site, Singapore

310016

RECRUITING

Research Site, Hangzhou

310022

RECRUITING

Research Site, Hangzhou

325000

RECRUITING

Research Site, Wenzhou

330009

RECRUITING

Research Site, Nanchang

350014

RECRUITING

Research Site, Fuzhou

361003

RECRUITING

Research Site, Xiamen

391760

RECRUITING

Research Site, Vadodara

395002

RECRUITING

Research Site, Surat

400030

WITHDRAWN

Research Site, Chongqing

410008

RECRUITING

Research Site, Changsha

410013

RECRUITING

Research Site, Changsha

422009

RECRUITING

Research Site, Nashik

430022

RECRUITING

Research Site, Wuhan

430079

RECRUITING

Research Site, Wuhan

440001

RECRUITING

Research Site, Nagpur

450008

RECRUITING

Research Site, Zhengzhou

450052

RECRUITING

Research Site, Zhengzhou

455000

NOT_YET_RECRUITING

Research Site, Anyang

460000

RECRUITING

Research Site, Vinh

510060

RECRUITING

Research Site, Guangzhou

510120

RECRUITING

Research Site, Guangzhou

510700

RECRUITING

Research Site, Guangzhou

524003

NOT_YET_RECRUITING

Research Site, Zhanjiang

530000

NOT_YET_RECRUITING

Research Site, Huế

530021

RECRUITING

Research Site, Nanning

530053

WITHDRAWN

Research Site, Visakhapatnam

550000

NOT_YET_RECRUITING

Research Site, Da Nang

570017

RECRUITING

Research Site, Mysuru

600031

RECRUITING

Research Site, Chennai

605006

RECRUITING

Research Site, Puducherry

610000

RECRUITING

Research Site, Chengdu

610041

RECRUITING

Research Site, Chengdu

673601

WITHDRAWN

Research Site, Calicut

682027

WITHDRAWN

Research Site, Kochi

695011

RECRUITING

Research Site, Thiruvananthapuram

700000

RECRUITING

Research Site, Ho Chi Minh City

RECRUITING

Research Site, Hồ Chí Minh

700160

WITHDRAWN

Research Site, Kolkata

710061

RECRUITING

Research Site, Xi'an

999077

NOT_YET_RECRUITING

Research Site, Hong Kong

2100008

RECRUITING

Research Site, Nanjing

06510

RECRUITING

Research Site, New Haven

02111

WITHDRAWN

Research Site, Boston

01655

WITHDRAWN

Research Site, Worcester

11794-7263

RECRUITING

Research Site, Stony Brook

02903

RECRUITING

Research Site, Providence

C1125ABD

RECRUITING

Research Site, Buenos Aires

C1425

WITHDRAWN

Research Site, CABA

C1015ABO

RECRUITING

Research Site, Ciudad de Buenos Aires

B2900

RECRUITING

Research Site, San Nicolás de los Arroyos

14784-400

RECRUITING

Research Site, Barretos

80730-150

RECRUITING

Research Site, Curitiba

88034-000

RECRUITING

Research Site, Florianópolis

74000-000

RECRUITING

Research Site, Goiânia

88301-220

RECRUITING

Research Site, Itajaí

90035-003

RECRUITING

Research Site, Porto Alegre

52010-075

RECRUITING

Research Site, Recife

01246-000

RECRUITING

Research Site, São Paulo

01317-001

RECRUITING

Research Site, São Paulo

64049-200

RECRUITING

Research Site, Teresina

L4M 6M2

RECRUITING

Research Site, Barrie

L8V 5C2

RECRUITING

Research Site, Hamilton

M5G 2M9

RECRUITING

Research Site, Toronto

J4V 2H1

RECRUITING

Research Site, Greenfield Park

H2X 0A9

RECRUITING

Research Site, Montreal

H4A 3J1

RECRUITING

Research Site, Montreal

G1S 4L8

RECRUITING

Research Site, Québec

S4T 7T1

RECRUITING

Research Site, Regina

S7N 4H4

RECRUITING

Research Site, Saskatoon

Unknown

RECRUITING

Research Site, Shandong

NOT_YET_RECRUITING

Research Site, Hong Kong

RECRUITING

Research Site, Besevler Ankara

04103

WITHDRAWN

Research Site, Leipzig

HKG

NOT_YET_RECRUITING

Research Site, Hong Kong

00000

NOT_YET_RECRUITING

Research Site, Shatin

00168

RECRUITING

Research Site, Roma

673-8558

RECRUITING

Research Site, Akashi-shi

113-8431

RECRUITING

Research Site, Bunkyō City

113-8677

RECRUITING

Research Site, Bunkyō City

260-8717

RECRUITING

Research Site, Chiba

104-0045

RECRUITING

Research Site, Chūōku

811-1395

RECRUITING

Research Site, Fukuoka

960-1295

RECRUITING

Research Site, Fukushima

501-1194

RECRUITING

Research Site, Gifu

350-1298

RECRUITING

Research Site, Hidaka-shi

730-8518

RECRUITING

Research Site, Hiroshima

734-8551

RECRUITING

Research Site, Hiroshima

259-1193

RECRUITING

Research Site, Isehara-shi

296-8602

RECRUITING

Research Site, Kamogawa-shi

277-8577

RECRUITING

Research Site, Kashiwa

362-0806

RECRUITING

Research Site, Kitaadachi-gun

135-8550

RECRUITING

Research Site, Kōtoku

860-8556

RECRUITING

Research Site, Kumamoto

830-0011

RECRUITING

Research Site, Kurume-shi

791-0280

RECRUITING

Research Site, Matsuyama

466-8560

RECRUITING

Research Site, Nagoya

467-8602

RECRUITING

Research Site, Nagoya

951-8566

RECRUITING

Research Site, Niigata

663-8501

RECRUITING

Research Site, Nishinomiya-shi

700-8558

RECRUITING

Research Site, Okayama

541-8567

RECRUITING

Research Site, Osaka

589-8511

RECRUITING

Research Site, Osakasayama-shi

373-8550

RECRUITING

Research Site, Ota-shi

003-0804

RECRUITING

Research Site, Sapporo

980-8574

RECRUITING

Research Site, Sendai

142-8666

RECRUITING

Research Site, Shinagawa-ku

160-0023

RECRUITING

Research Site, Shinjuku-ku

162-8655

RECRUITING

Research Site, Shinjuku-ku

514-8507

RECRUITING

Research Site, Tsu

305-8577

RECRUITING

Research Site, Tsukuba

241-8515

RECRUITING

Research Site, Yokohama

04980

NOT_YET_RECRUITING

Research Site, CD Mexico

0 3100

RECRUITING

Research Site, Mexico City

04700

RECRUITING

Research Site, México

15-027

WITHDRAWN

Research Site, Bialystok

85-796

WITHDRAWN

Research Site, Bydgoszcz

80-952

NOT_YET_RECRUITING

Research Site, Gdansk

81-519

WITHDRAWN

Research Site, Gdynia

62-500

WITHDRAWN

Research Site, Konin

31-115

WITHDRAWN

Research Site, Krakow

59-220

WITHDRAWN

Research Site, Legnica

90-302

NOT_YET_RECRUITING

Research Site, Lodz

20-090

WITHDRAWN

Research Site, Lublin

37-700

WITHDRAWN

Research Site, Przemyśl

02-781

NOT_YET_RECRUITING

Research Site, Warsaw

53-413

WITHDRAWN

Research Site, Wroclaw

0081

RECRUITING

Research Site, Pretoria

02841

RECRUITING

Research Site, Seoul

03080

RECRUITING

Research Site, Seoul

03722

RECRUITING

Research Site, Seoul

05505

RECRUITING

Research Site, Seoul

06273

RECRUITING

Research Site, Seoul

06351

RECRUITING

Research Site, Seoul

06591

RECRUITING

Research Site, Seoul

08028

WITHDRAWN

Research Site, Barcelona

08907

RECRUITING

Research Site, Hospitalet deLlobregat

06520

RECRUITING

Research Site, Ankara

CF14 2TL

RECRUITING

Research Site, Cardiff

SW3 6JJ

RECRUITING

Research Site, Chelsea

Le5 4PW

RECRUITING

Research Site, Leicester

L7 8YA

RECRUITING

Research Site, Liverpool

EC1A 7BE

RECRUITING

Research Site, London

SW17 0QT

WITHDRAWN

Research Site, London

OX3 7LE

RECRUITING

Research Site, Oxford

GU2 7XX

SUSPENDED

Research Site, Surrey

SM2 5PT

RECRUITING

Research Site, Sutton

TA1 5DA

RECRUITING

Research Site, Taunton

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Daiichi Sankyo

INDUSTRY

lead

AstraZeneca

INDUSTRY

NCT06103864 - A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer | Biotech Hunter | Biotech Hunter