A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,174

Participants

Timeline

Start Date

November 28, 2022

Primary Completion Date

September 20, 2027

Study Completion Date

January 30, 2030

Conditions
Breast Cancer
Interventions
DRUG

Dato-DXd

Experimental drug. Provided in 100mg vials. IV infusion

DRUG

Durvalumab

Experimental drug. Provided in 50mg vials. IV infusion

DRUG

Capecitabine

Active Comparator. Tablet. Oral route of administration

DRUG

Pembrolizumab

Active Comparator. Provided in 100mg vials. IV infusion

Trial Locations (276)

112

Research Site, Taipei

300

Research Site, Hsinchu

333

Research Site, Taoyuan District

1070

Research Site, Anderlecht

1090

Research Site, Brussels

1200

Research Site, Brussels

2100

Research Site, Copenhagen

2610

Research Site, Wilrijk

2650

Research Site, Edegem

3500

Research Site, Hasselt

4000

Research Site, Liège

4103

Research Site, Leipzig

4700

Research Site, Næstved

5000

Research Site, Namur

Research Site, Odense

6060

Research Site, Charleroi

6400

Research Site, Sønderborg

7100

Research Site, Vejle

7400

Research Site, Herning

8035

Research Site, Barcelona

9000

Research Site, Ghent

9100

Research Site, Sint-Niklaas

10002

Research Site, Taipei

10011

Research Site, New York

10021

Research Site, New York

10029

Research Site, New York

10032

Research Site, New York

10065

Research Site, New York

10408

Research Site, Goyang-si

10449

Research Site, Taipei

11281

Research Site, Stockholm

11528

Research Site, Athens

12462

Research Site, Athens

15213

Research Site, Pittsburgh

16132

Research Site, Genova

17033

Research Site, Hershey

17176

Research Site, Stockholm

19111

Research Site, Philadelphia

19713

Research Site, Newark

20007

Research Site, Washington D.C.

20089

Research Site, Rozzano

20132

Research Site, Milan

20141

Research Site, Milan

20155

Research Site, Gainesville

20357

Research Site, Hamburg

21000

Research Site, Dijon

21044

Research Site, Columbia

21202

Research Site, Baltimore

21401

Research Site, Annapolis

22031

Research Site, Fairfax

23114

Research Site, Midlothian

23502

Research Site, Norfolk

24105

Research Site, Kiel

25123

Research Site, Brescia

26506

Research Site, Morgantown

28040

Research Site, Madrid

28041

Research Site, Madrid

28204

Research Site, Charlotte

29010

Research Site, Málaga

30029

Research Site, Nîmes

30177

Research Site, Hanover

30318

Research Site, Atlanta

30322

Research Site, Atlanta

30607

Research Site, Athens

32308

Research Site, Tallahassee

32701

Research Site, Altamonte Springs

33021

Research Site, Hollywood

33076

Research Site, Bordeaux

33098

Research Site, Paderborn

33140

Research Site, Miami Beach

33401

Research Site, West Palm Beach

34070

Research Site, Montpellier

35000

Research Site, Rennes

35128

Research Site, Padua

37203

Research Site, Nashville

37232

Research Site, Nashville

38120

Research Site, Memphis

38138

Research Site, Germantown

40138

Research Site, Bologna

40202

Research Site, Louisville

40207

Research Site, Louisville

40241

Research Site, Louisville

40447

Research Site, Taichung

40503

Research Site, Lexington

41061

Research Site, Mönchengladbach

41404

Research Site, Daegu

42283

Research Site, Wuppertal

43219

Research Site, Columbus

44106

Research Site, Cleveland

44111

Research Site, Cleveland

44195

Research Site, Cleveland

44710

Research Site, Canton

44805

Research Site, Saint-Herblain

45007

Research Site, Toledo

46010

Research Site, Valencia

47014

Research Site, Meldola

48013

Research Site, Bilbao (Vizcaya)

48201

Research Site, Detroit

49055

Research Site, Angers

49241

Research Site, Busan

50134

Research Site, Florence

53840

Research Site, Troisdorf

54639

Research Site, Thessaloniki

57001

Research Site, Thessaloniki

57124

Research Site, Livorno

60153

Research Site, Maywood

60611

Research Site, Chicago

63110

Research Site, St Louis

63225

Research Site, Langen

65929

Research Site, Frankfurt am Main

66205

Research Site, Westwood

69008

Research Site, Lyon

70121

Research Site, New Orleans

70199

Research Site, Stuttgart

70403

Research Site, Tainan City

71044

Research Site, Yung Kang City

71110

Research Site, Heraklion

71640

Research Site, Ludwigsburg

71913

Research Site, Hot Springs

72076

Research Site, Tübingen

72205

Research Site, Little Rock

72762

Research Site, Springdale

74078

Research Site, Heilbronn

75246

Research Site, Dallas

75248

Research Site, Paris

76022

Research Site, Bedford

76104

Research Site, Fort Worth

76177

Research Site, Fort Worth

76201

Research Site, Denton

77024

Research Site, Houston

77030

Research Site, Houston

78503

Research Site, McAllen

80131

Research Site, Napoli

80220

Research Site, Denver

80337

Research Site, München

85234

Research Site, Gilbert

85711

Research Site, Tucson

85719

Research Site, Tucson

86021

Research Site, Poitiers

87109

Research Site, Albuquerque

90017

Research Site, Los Angeles

90095

Research Site, Los Angeles

90211

Research Site, Beverly Hills

90805

Research Site, Lakewood

91010

Research Site, Duarte

91786

Research Site, Upland

92093

Research Site, La Jolla

92618

Research Site, Irvine

92627

Research Site, Costa Mesa

92660

Research Site, Newport Beach

92663

Research Site, Newport Beach

92708

Research Site, Fountain Valley

92868

Research Site, Orange

93053

Research Site, Regensburg

94589

Research Site, Vallejo

94805

Research Site, Villejuif

95661

Research Site, Roseville

97227

Research Site, Portland

98026

Research Site, Edmonds

98029

Research Site, Issaquah

98104

Research Site, Seattle

98133

Research Site, Seattle

98158

Research Site, Messina

98373

Research Site, Puyallup

99216

Research Site, Spokane Valley

100044

Research Site, Beijing

100142

Research Site, Beijing

110016

Research Site, Qingdao

130021

Research Site, Changchun

150081

Research Site, Harbin

200025

Research Site, Shanghai

200032

Research Site, Shanghai

210008

Research Site, Nanjing

210009

Research Site, Nanjing

230001

Research Site, Hefei

233004

Research Site, Bengbu

250030

Research Site, Jinan

300060

Research Site, Tianjin

310009

Research Site, Hangzhou

310020

Research Site, Hangzhou

330009

Research Site, Nanchang

350011

Research Site, Fuzhou

361003

Research Site, Xiamen

400030

Research Site, Chongqing

410008

Research Site, Changsha

430022

Research Site, Wuhan

430060

Research Site, Wuhan

450052

Research Site, Zhengzhou

510060

Research Site, Guangzhou

510100

Research Site, Guangzhou

510120

Research Site, Guangzhou

510700

Research Site, Guangzhou

518020

Research Site, Shenzhen

530021

Research Site, Nanning

570311

Research Site, Haikou

610000

Research Site, Chengdu

610072

Research Site, Chengdu

710038

Research Site, Xi'an

06510

Research Site, New Haven

02114

Research Site, Boston

08103

Research Site, Camden

02903

Research Site, Providence

71681-603

Research Site, Brasília

90035-000

Research Site, Porto Alegre

52010-075

Research Site, Recife

41253-190

Research Site, Salvador

01321-001

Research Site, São Paulo

01508-010

Research Site, São Paulo

03102-002

Research Site, São Paulo

04532-030

Research Site, São Paulo

29055-450

Research Site, Vitória

V7L 2L7

Research Site, North Vancouver

L4M 6M2

Research Site, Barrie

K7L 2V7

Research Site, Kingston

L9T 6G2

Research Site, Oakville

K1H 8L6

Research Site, Ottawa

M5G 1X5

Research Site, Toronto

M5G 2M9

Research Site, Toronto

H7M 3L9

Research Site, Laval

H2X 0C1

Research Site, Montreal

H3T 1E2

Research Site, Montreal

H4A 3J1

Research Site, Montreal

G1S 4L8

Research Site, Québec

S7N 4H4

Research Site, Saskatoon

050020

Research Site, Shijiazhuang

115 22

Research Site, Athens

00168

Research Site, Roma

673-8558

Research Site, Akashi-shi

260-8717

Research Site, Chiba

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

277-8577

Research Site, Kashiwa

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

700-8558

Research Site, Okayama

541-8567

Research Site, Osaka

373-8550

Research Site, Ota-shi

003-0804

Research Site, Sapporo

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

00918

Research Site, San Juan

463-712

Research Site, Seongnam-si

02841

Research Site, Seoul

03080

Research Site, Seoul

03722

Research Site, Seoul

05505

Research Site, Seoul

06273

Research Site, Seoul

06351

Research Site, Seoul

08028

Research Site, Barcelona

03202

Research Site, Elche(Alicante)

07010

Research Site, Palma de Mallorca

851 86

Research Site, Sundsvall

751 85

Research Site, Uppsala

CB2 0QQ

Research Site, Cambridge

CF14 2TL

Research Site, Cardiff

EH4 2XU

Research Site, Edinburgh

SW3 6JJ

Research Site, Greater London

EC1A 7BE

Research Site, London

SE1 9RT

Research Site, London

BT47 6SB

Research Site, Londonderry

M20 4BX

Research Site, Manchester

NE7 7AF

Research Site, Newcastle upon Tyne

PO6 3LY

Research Site, Portsmouth

SM2 5PT

Research Site, Surrey

TA1 5DA

Research Site, Taunton

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Daiichi Sankyo

INDUSTRY

collaborator

SWOG Clinical Trials Partnerships

UNKNOWN

lead

AstraZeneca

INDUSTRY