A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,902

Participants

Timeline

Start Date

November 14, 2023

Primary Completion Date

November 20, 2028

Study Completion Date

September 23, 2032

Conditions
Breast Cancer
Interventions
DRUG

Dato-DXd

Experimental drug IV infusion

DRUG

Durvalumab

Experimental drug IV Infusion

DRUG

Pembrolizumab

IV Infusion Active comparator

DRUG

Doxorubicin

IV infusion Experimental/Active Comparator

DRUG

Epirubicin

IV Infusion Experimental/Active Comparator

DRUG

Cyclophosphamide

IV infusion Experimental/Active Comparator

DRUG

Paclitaxel

IV infusion Experimental/Active Comparator

DRUG

Carboplatin

IV infusion Experimental/Active Comparator

DRUG

Capecitabine

Tablet Oral route of administration Experimental/Active Comparator

DRUG

Olaparib

Tablet Oral route of administration Experimental/Active Comparator

Trial Locations (283)

112

Research Site, Taipei

333

Research Site, Taoyuan District

500

Research Site, Changhua

704

Research Site, Tainan City

1122

Research Site, Budapest

1330

Research Site, Sofia

2020

Research Site, Antwerp

2930

Research Site, Brasschaat

3000

Research Site, Leuven

3002

Research Site, East Melbourne

3010

Research Site, Bern

3526

Research Site, Miskolc

4010

Research Site, Linz

4031

Research Site, Basel

5020

Research Site, Salzburg

6000

Research Site, Kecskemét

6020

Research Site, Innsbruck

6060

Research Site, Charleroi

6800

Research Site, Libramont-Chevigny

6807

Research Site, Feldkirch

7100

Research Site, Szekszárd

8501

Research Site, Frauenfeld

9000

Research Site, Ghent

9700

Research Site, Shumen

10002

Research Site, Taipei

10065

Research Site, New York

10126

Research Site, Torino

10210

Research Site, Bangkok

10300

Research Site, Dusit

10330

Research Site, Bangkok

10408

Research Site, Goyang-si

10449

Research Site, Taipei

10967

Research Site, Berlin

10990

Research Site, George Town

13125

Research Site, Berlin

13273

Research Site, Marseille

13620

Research Site, Seongnam

15212

Research Site, Pittsburgh

15706

Research Site, Santiago de Compostela

18016

Research Site, Granada

19104

Research Site, Philadelphia

20089

Research Site, Rozzano

20132

Research Site, Milan

20246

Research Site, Hamburg

21401

Research Site, Annapolis

22031

Research Site, Fairfax

22601

Research Site, Winchester

23502

Research Site, Norfolk

24014

Research Site, Roanoke

24105

Research Site, Kiel

27103

Research Site, Winston-Salem

27710

Research Site, Durham

28007

Research Site, Madrid

28034

Research Site, Madrid

28204

Research Site, Charlotte

30342

Research Site, Atlanta

30559

Research Site, Hanover

31100

Research Site, Toulouse

32256

Research Site, Jacksonville

33100

Research Site, Udine

33401

Research Site, West Palm Beach

33705

Research Site, St. Petersburg

33901

Research Site, Fort Myers

34298

Research Site, Montpellier

34722

Research Site, Istanbul

35128

Research Site, Padua

36526

Research Site, Daphne

37203

Research Site, Nashville

37404

Research Site, Chattanooga

38039

Research Site, Kayseri

40202

Research Site, Louisville

40447

Research Site, Taichung

41009

Research Site, Seville

41017

Research Site, Edgewood

41076

Research Site, Caen

41124

Research Site, Modena

41404

Research Site, Daegu

45130

Research Site, Essen

45242

Research Site, Blue Ash

48149

Research Site, Münster

49503

Research Site, Grand Rapids

49684

Research Site, Traverse City

50009

Research Site, Zaragoza

50053

Research Site, Empoli

50200

Research Site, Muang

50309

Research Site, Des Moines

50586

Research Site, Kuala Lumpur

51056

Research Site, Reims

54031

Research Site, Xintai

54290

Research Site, Trier

Research Site, Adapazarı

54519

Research Site, Vandœuvre-lès-Nancy

55100

Research Site, Lucca

55131

Research Site, Mainz

55200

Research Site, Samsun

55337

Research Site, Burnsville

55407

Research Site, Minneapolis

59100

Research Site, Kuala Lumpur

60431

Research Site, Frankfurt am Main

62100

Research Site, Macerata

62250

Research Site, Kuala Selangor

63011

Research Site, Clermont-Ferrand

64100

Research Site, Bayonne

65212

Research Site, Columbia

68130

Research Site, Omaha

68167

Research Site, Mannheim

69120

Research Site, Heidelberg

70817

Research Site, Baton Rouge

72401

Research Site, Jonesboro

72758

Research Site, Rogers

73039

Research Site, Tricase

73730

Research Site, Esslingen am Neckar

75010

Research Site, Paris

75028

Research Site, Flower Mound

75231

Research Site, Dallas

75235

Research Site, Dallas

76104

Research Site, Fort Worth

77030

Research Site, Houston

77598

Research Site, Webster

78240

Research Site, San Antonio

78731

Research Site, Austin

79110

Research Site, Freiburg im Breisgau

79902

Research Site, El Paso

80045

Research Site, Aurora

80131

Research Site, Napoli

80504

Research Site, Longmont

80637

Research Site, München

82445

Research Site, Kaohsiung City

84918

Research Site, Avignon

86150

Research Site, Augsburg

86301

Research Site, Prescott

87000

Research Site, Limoges

87505

Research Site, Santa Fe

89075

Research Site, Ulm

90033

Research Site, Los Angeles

90110

Research Site, Songkhla

90505

Research Site, Torrance

91054

Research Site, Erlangen

92805

Research Site, Santa Rosa

93105

Research Site, Santa Barbara

93586

Research Site, Kuching

94805

Research Site, Villejuif

97223

Research Site, Portland

97401

Research Site, Eugene

98405

Research Site, Tacoma

100000

Research Site, Hanoi

100044

Research Site, Beijing

110004

Research Site, Shenyang

110029

Research Site, Delhi

110085

Research Site, Delhi

130021

Research Site, Changchun

150049

Research Site, Harbin

168583

Research Site, Singapore

200025

Research Site, Shanghai

210008

Research Site, Nanjing

233004

Research Site, Bengbu

250117

Research Site, Jinan

300000

Research Site, Tianjin

302004

Research Site, Marg Jaipur

310009

Research Site, Hangzhou

310022

Research Site, Hangzhou

317000

Research Site, Linhai

330009

Research Site, Nanchang

330029

Research Site, Nanchang

391760

Research Site, Vadodara

410008

Research Site, Changsha

422011

Research Site, Nashik

430022

Research Site, Wuhan

440001

Research Site, Nagpur

450008

Research Site, Zhengzhou

460000

Research Site, Vinh

510060

Research Site, Guangzhou

510120

Research Site, Guangzhou

526000

Research Site, Zhaoqing

530021

Research Site, Nanning

560085

Research Site, Bengaluru

610000

Research Site, Chengdu

629000

Research Site, Suining

695011

Research Site, Thiruvananthapuram

700000

Research Site, Ho Chi Minh City

Research Site, Hồ Chí Minh

700016

Research Site, Kolkata

700099

Research Site, Kolkata

710061

Research Site, Xi'an

999077

Research Site, Hong Kong

06606

Research Site, Bridgeport

06510

Research Site, New Haven

02215

Research Site, Boston

08816

Research Site, East Brunswick

08901

Research Site, New Brunswick

75390-8843

Research Site, Dallas

71681-603

Research Site, Brasília

80440-220

Research Site, Curitiba

60336-045

Research Site, Fortaleza

86015-520

Research Site, Londrina

59075-740

Research Site, Natal

90035-000

Research Site, Porto Alegre

90035-903

Research Site, Porto Alegre

14051-140

Research Site, Ribeirão Preto

09060-650

Research Site, Santo André

01246-000

Research Site, São Paulo

12030-200

Research Site, Taubaté

29043-260

Research Site, Vitória

Unknown

Research Site, Sofia

T2N 5G2

Research Site, Calgary

VSZ 4E6

Research Site, Vancouver

L4M 6M2

Research Site, Barrie

N6A 5W9

Research Site, London

L1G 2B9

Research Site, Oshawa

M5G 2M9

Research Site, Toronto

G6V 3Z1

Research Site, Lévis

H1T 2M4

Research Site, Montreal

H2X 0C1

Research Site, Montreal

H4A-3J1

Research Site, Montreal

J7Z 5T3

Research Site, Saint-Jérôme

J1H 5N4

Research Site, Sherbrooke

H3T 1E2

Research Site, Montreal

K1H 8L6

Research Site, Ottawa

050020

Research Site, Shijiazhuang

06100

Research Site, Nice

06847

Research Site, Dessau

01307

Research Site, Dresden

00168

Research Site, Roma

673-8558

Research Site, Akashi-shi

010-8543

Research Site, Akita

113-8431

Research Site, Bunkyō City

260-8717

Research Site, Chiba

104-0045

Research Site, Chūōku

104-8560

Research Site, Chūōku

811-1395

Research Site, Fukuoka

960-1295

Research Site, Fukushima

501-1194

Research Site, Gifu

350-1298

Research Site, Hidaka-shi

573-1191

Research Site, Hirakata-shi

730-0011

Research Site, Hiroshima

734-8551

Research Site, Hiroshima

259-1193

Research Site, Isehara-shi

227-8577

Research Site, Kashiwa

860-8556

Research Site, Kumamoto

830-0011

Research Site, Kurume-shi

606-8507

Research Site, Kyoto

791-0280

Research Site, Matsuyama

460-0001

Research Site, Nagoya

466-8560

Research Site, Nagoya

467-0001

Research Site, Nagoya

951-8566

Research Site, Niigata

700-8558

Research Site, Okayama

541-8567

Research Site, Osaka

003-0804

Research Site, Sapporo

060-8648

Research Site, Sapporo

980-8574

Research Site, Sendai

142-8666

Research Site, Shinagawa-ku

160-0023

Research Site, Shinjuku-ku

162-8655

Research Site, Shinjuku-ku

411-8777

Research Site, Sunto-gun

514-8507

Research Site, Tsu

241-8515

Research Site, Yokohama

15-027

Research Site, Bialystok

85-796

Research Site, Bydgoszcz

81-519

Research Site, Gdynia

31-501

Research Site, Krakow

93-338

Research Site, Lodz

02-781

Research Site, Warsaw

02841

Research Site, Seoul

03080

Research Site, Seoul

03722

Research Site, Seoul

05505

Research Site, Seoul

06273

Research Site, Seoul

06351

Research Site, Seoul

06591

Research Site, Seoul

08036

Research Site, Barcelona

08907

Research Site, Hospitalet deLlobregat

CH-5405

Research Site, Baden

06010

Research Site, Ankara

06340

Research Site, Ankara

06520

Research Site, Ankara

B15 2TG

Research Site, Birmingham

CF14 2TL

Research Site, Cardiff

LA1 4RP

Research Site, Lancaster

EC1A 7BE

Research Site, London

NN1 5BD

Research Site, Northampton

OX3 7LE

Research Site, Oxford

TA1 5DA

Research Site, Taunton

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Daiichi Sankyo

INDUSTRY

lead

AstraZeneca

INDUSTRY