A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)

PHASE3RecruitingINTERVENTIONAL
Enrollment

532

Participants

Timeline

Start Date

January 18, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

July 31, 2028

Conditions
Metastatic Breast Cancer
Interventions
DRUG

DB-1303/BNT323

IV

DRUG

Capecitabine

Oral

DRUG

Paclitaxel

IV

DRUG

Nab-paclitaxel

IV

Trial Locations (253)

0

RECRUITING

Research Site 8502-0, Hong Kong

RECRUITING

Research Site 8505-0, Hong Kong

1082

RECRUITING

Research Site 3603-0, Budapest

1090

RECRUITING

Research Site 3205-0, Jette

1200

RECRUITING

Research Site 3201-0, Brussels

1431

RECRUITING

Research Site 5407-0, Ciudad Autonoma Buenos Aires

2000

RECRUITING

Research Site 5401-0, Rosario

2050

RECRUITING

Research Site 6108-0, Camperdown

2109

RECRUITING

Research Site 6102-0, Sydney

2155

RECRUITING

Research Site 6110-0, Adelaide

2170

RECRUITING

Research Site 6109-0, Liverpool

2747

RECRUITING

Research Site 6116-0, Kingswood

2800

RECRUITING

Research Site 3607-0, Tatabánya

2841

RECRUITING

Research Site 8201-0, Seoul

3000

RECRUITING

Research Site 3203-0, Leuven

3021

RECRUITING

Research Site 6105-0, St Albans

3100

RECRUITING

Research Site 3602-0, Salgótarján

3550

RECRUITING

Research Site 6103-0, Bendigo

3722

RECRUITING

Research Site 8206-0, Seoul

3844

RECRUITING

Research Site 6113-0, Traralgon

4000

RECRUITING

Research Site 3207-0, Liège

4101

RECRUITING

Research Site 6101-0, South Brisbane

4215

RECRUITING

Research Site 6107-0, Southport

4575

RECRUITING

Research Site 6106-0, Birtinya

4814

RECRUITING

Research Site 6104-0, Townsville

5505

RECRUITING

Research Site 8210-0, Seoul

6009

RECRUITING

Research Site 6114-0, Perth

6591

RECRUITING

Research Site 8203-0, Seoul

7600

RECRUITING

Research Site 5413-0, Mar del Plata

8308

RECRUITING

Research Site 8205-0, Seoul

8800

RECRUITING

Research Site 3202-0, Roeselare

8900

RECRUITING

Research Site 3605-0, Zalaegerszeg

9000

RECRUITING

Research Site 3204-0, Ghent

9024

RECRUITING

Research Site 3606-0, Győr

10314

RECRUITING

Research Site 1148-0, Staten Island

10967

RECRUITING

Research Site 4905-0, Berlin

11590

RECRUITING

Research Site 1105-0, Westbury

13125

RECRUITING

Research Site 4906-0, Berlin

13915

RECRUITING

Research Site 3311-0, Marseille

15706

RECRUITING

Research Site 3409-0, Santiago de Compostela

16499

RECRUITING

Research Site 8202-0, Suwon

17019

RECRUITING

Research Site 3303-0, La Rochelle

19008

RECRUITING

Research Site 1134-0, Broomall

19044

RECRUITING

Research Site 1123-0, Horsham

20132

RECRUITING

Research Site 3906-0, Milan

20133

RECRUITING

Research Site 3911-0, Milan

20141

RECRUITING

Research Site 3904-0, Milan

20904

RECRUITING

Research Site 1122-0, Silver Spring

RECRUITING

Research Site 8639-0, Silver Spring

21280

RECRUITING

Research Site 9009-0, Diyarbakır

21565

RECRUITING

Research Site 8209-0, Incheon

22031

RECRUITING

Research Site 1108-0, Fairfax

RECRUITING

Research Site 1131-0, Fairfax

24014

RECRUITING

Research Site 1127-0, Roanoke

24125

RECRUITING

Research Site 3908-0, Bergamo

25000

RECRUITING

Research Site 3312-0, Besançon

25124

RECRUITING

Research Site 3907-0, Brescia

26426

RECRUITING

Research Site 8211-0, Wŏnju

27100

RECRUITING

Research Site 3902-0, Pavia

27599

RECRUITING

Research Site 1144-0, Chapel Hill

28003

RECRUITING

Research Site 3416-0, Madrid

28040

RECRUITING

Research Site 3407-0, Madrid

RECRUITING

Research Site 3414-0, Madrid

28050

RECRUITING

Research Site 3401-0, Madrid

28220

RECRUITING

Research Site 3406-0, Majadahonda

28223

RECRUITING

Research Site 3411-0, Pozuelo de Alarcón

29010

RECRUITING

Research Site 3415-0, Málaga

29016

RECRUITING

Research Site 3418-0, Málaga

30029

RECRUITING

Research Site 3308-0, Nîmes

31008

RECRUITING

Research Site 3405-0, Pamplona

31059

RECRUITING

Research Site 3305-0, Toulouse

31151

RECRUITING

Research Site 8212-0, Cheonan

31405

RECRUITING

Research Site 1110-0, Savannah

32256

RECRUITING

Research Site 1154-0, Jacksonville

32763

RECRUITING

Research Site 1150-0, Orange City

32909

RECRUITING

Research Site 1125-0, Palm Bay

33077

RECRUITING

Research Site 3314-0, Bordeaux

33136

RECRUITING

Research Site 1145-0, Miami

34070

RECRUITING

Research Site 3304-0, Montpellier

34147

RECRUITING

Research Site 9008-0, Istanbul

35575

RECRUITING

Research Site 9010-0, Izmir

37124

RECRUITING

Research Site 3905-0, Verona

37203

RECRUITING

Research Site 1102-0, Nashville

37909

RECRUITING

Research Site 1149-0, Knoxville

40202

RECRUITING

Research Site 1104-0, Louisville

41009

RECRUITING

Research Site 3408-0, Seville

41013

RECRUITING

Research Site 3413-0, Seville

RECRUITING

Research Site 3417-0, Seville

44033

RECRUITING

Research Site 8214-0, Ulsan

44305

RECRUITING

Research Site 1138-0, Akron

44800

RECRUITING

Research Site 3310-0, Saint-Herblain

45220

RECRUITING

Research Site 1160-0, Cincinnati

46010

RECRUITING

Research Site 3412-0, Valencia

46236

RECRUITING

Research Site 4904-0, Bottrop

46804

RECRUITING

Research Site 1152-0, Fort Wayne

49055

RECRUITING

Research Site 3301-0, Angers

49201

RECRUITING

Research Site 8208-0, Busan

50011

RECRUITING

Research Site 8645-0, Shijiazhuang

52621

RECRUITING

Research Site 9709-0, Ramat Gan

55139

RECRUITING

Research Site 9007-0, Samsun

58452

RECRUITING

Research Site 4901-0, Witten

59020

RECRUITING

Research Site 3315-0, Lille

60415

RECRUITING

Research Site 1124-0, Chicago Ridge

60611

RECRUITING

Research Site 1147-0, Chicago

64109

RECRUITING

Research Site 3306-0, Bayonne

64111

RECRUITING

Research Site 1109-0, Kansas City

64239

RECRUITING

Research Site 9701-0, Tel Aviv

65199

RECRUITING

Research Site 4909-0, Wiesbaden

66204

RECRUITING

Research Site 1106-0, Merriam

69495

RECRUITING

Research Site 3318-0, Pierre-Bénite

75010

RECRUITING

Research Site 3316-0, Paris

75020

RECRUITING

Research Site 1116-0, Denison

75246

RECRUITING

Research Site 1101-0, Dallas

76038

RECRUITING

Research Site 3313-0, Rouen

77030

RECRUITING

Research Site 1115-0, Houston

78240

RECRUITING

Research Site 1117-0, San Antonio

80045

RECRUITING

Research Site 1137-0, Aurora

80124

RECRUITING

Research Site 1129-0, Lone Tree

80131

RECRUITING

Research Site 3909-0, Napoli

84124

RECRUITING

Research Site 1130-0, Salt Lake City

84918

RECRUITING

Research Site 3307-0, Avignon

85704

RECRUITING

Research Site 1141-0, Tucson

87000

RECRUITING

Research Site 3309-0, Limoges

87505

RECRUITING

Research Site 1157-0, Santa Fe

88100

RECRUITING

Research Site 3903-0, Catanzaro

90095

RECRUITING

Research Site 1107-0, Los Angeles

91054

RECRUITING

Research Site 4907-0, Erlangen

91120

RECRUITING

Research Site 9707-0, Jerusalem

92835

RECRUITING

Research Site 1114-0, Fullerton

93105

RECRUITING

Research Site 1132-0, Santa Barbara

94010

RECRUITING

Research Site 3302-0, Créteil

95123

RECRUITING

Research Site 3901-0, Catania

95814

RECRUITING

Research Site 1143-0, Sacramento

97223

RECRUITING

Research Site 1126-0, Tigard

100021

RECRUITING

Research Site 8601-0, Beijing

100071

RECRUITING

Research Site 8625-0, Beijing

100142

RECRUITING

Research Site 8653-0, Beijing

110001

RECRUITING

Research Site 8643-0, Shenyang

110042

RECRUITING

Research Site 8642-0, Shenyang

116027

RECRUITING

Research Site 8636-0, Dalian

RECRUITING

Research Site-8636-0, Dalian

130000

RECRUITING

Research Site 8612-0, Changchun

130021

RECRUITING

Research Site 8618-0, Changchun

130041

RECRUITING

Research Site 8644-0, Changchun

150081

RECRUITING

Research Site 8619-0, Harbin

200025

RECRUITING

Research Site 8603-0, Shanghai

200032

RECRUITING

Research Site 8602-0, Shanghai

210029

RECRUITING

Research Site 8607-0, Nanjing

221009

RECRUITING

Research Site 8624-0, Xuzhou

223300

RECRUITING

Research Site 8646-0, Huai'an

230088

RECRUITING

Research Site 8640-0, Hefei

230601

RECRUITING

Research Site 8614-0, Hefei

250117

RECRUITING

Research Site 8634-0, Jinan

264200

RECRUITING

Research Site 8650-0, Weihai

272029

RECRUITING

Research Site 8613-0, Jining

276000

RECRUITING

Research Site 8610-0, Linyi

300453

RECRUITING

Research Site 8617-0, Tianjin

310000

RECRUITING

Research Site 8652-0, Hangzhou

310016

RECRUITING

Research Site 8620-0, Hangzhou

310022

RECRUITING

Research Site 8641-0, Hangzhou

330009

RECRUITING

Research Site 8631-0, Nanchang

350015

RECRUITING

Research Site 8651-0, Fuzhou

361003

RECRUITING

Research Site 8638-0, Xiamen

400030

RECRUITING

Research Site 8627-0, Chongqing

410005

RECRUITING

Research Site 8635-0, Changsha

425000

RECRUITING

Research Site 8654-0, Yongzhou

430022

RECRUITING

Research Site 8637-0, Wuhan

430079

RECRUITING

Research Site 8608-0, Wuhan

RECRUITING

Research Site 8633-0, Xiangyang

450000

RECRUITING

Research Site 8605-0, Zhengzhou

450003

RECRUITING

Research Site 8623-0, Zhengzhou

453100

RECRUITING

Research Site 8648-0, Weihui

455000

RECRUITING

Research Site 8649-0, Anyang

471003

RECRUITING

Research Site 8609-0, Luoyang

510000

RECRUITING

Research Site 8604-0, Guangzhou

510060

RECRUITING

Research Site 8628-0, Guangzhou

516003

RECRUITING

Research Site 8621-0, Huizhou

519000

RECRUITING

Research Site 8622-0, Zhuhai

530021

RECRUITING

Research Site 8615-0, Nanning

610041

RECRUITING

Research Site 8606-0, Chengdu

641000

NOT_YET_RECRUITING

Research Site 8626-0, Neijiang

643000

RECRUITING

Research Site 8647-0, Zigong

650118

RECRUITING

Research Site 8632-0, Kunming

710061

RECRUITING

Research Site 8611-0, Xi’an

730000

RECRUITING

Research Site 8630-0, Lanzhou

830000

RECRUITING

Research Site 8616-0, Ürümqi

3109601

RECRUITING

Research Site 9706-0, Haifa

3436212

RECRUITING

Research Site 9708-0, Haifa

4428164

RECRUITING

Research Site 9703-0, Kfar Saba

4941492

RECRUITING

Research Site 9704-0, Petah Tikva

7610001

RECRUITING

Research Site 9705-0, Rehovot

7747629

RECRUITING

Research Site 9710-0, Ashdod

9103102

RECRUITING

Research Site 9702-0, Jerusalem

92868-3201

RECRUITING

Research Site 1118-0, Orange

07932

RECRUITING

Research Site 1111-0, Florham Park

97401-8122

RECRUITING

Research Site 1133-0, Eugene

B8001HXM

RECRUITING

Research Site 5411-0, Bahía Blanca

C1015ABO

RECRUITING

Research Site 5414-0, CABA

B1902CMJ

RECRUITING

Research Site 5405-0, La Plata

B1878GEG

RECRUITING

Research Site 5408-0, Quilmes

C1426ANZ

RECRUITING

Research Site 5403-0, CABA

R8500ACE

RECRUITING

Research Site 5402-0, Viedma

S2000KZE

RECRUITING

Research Site 5406-0, Rosario

T4000AXL

RECRUITING

Research Site 5404-0, San Miguel de Tucumán

C1280AEB

RECRUITING

Research Site 5409-0, Ciudad Autonoma Buenos Aires

R3E 0V9

RECRUITING

Research Site 1007-0, Winnipeg

L6R 3J7

RECRUITING

Research Site 1003-0, Brampton

M2K 1E1

RECRUITING

Research Site 1001-0, Toronto

H3T 1E2

RECRUITING

Research Site 1004-0, Montreal

H3T 1M5

RECRUITING

Research Site 1005-0, Montreal

H4A 3J1

RECRUITING

Research Site 1006-0, Montreal

J1H5N4

RECRUITING

Research Site 1002-0, Sherbrooke

071000

RECRUITING

Research Site, Baoding

071030

RECRUITING

Research Site 8629-0, Baoding

01307

RECRUITING

Research Site 4903-0, Dresden

00000

RECRUITING

Research Site 8504-0, Hong Kong

0000

RECRUITING

Research Site 8501-0, Hong Kong

RECRUITING

Research Site 8503-0, Hong Kong

Kecskemet

RECRUITING

Research Site 3604-0, Kecskemét

31-501

RECRUITING

Research Site 4804-0, Krakow

90-302

RECRUITING

Research Site 4803-0, Lodz

61-866

RECRUITING

Research Site 4801-0, Poznan

35-021

RECRUITING

Research Site 4802-0, Rzeszów

87-100

RECRUITING

Research Site 4807-0, Torun

04-141

RECRUITING

Research Site 4805-0, Warsaw

53-673

RECRUITING

Research Site 4809-0, Wroclaw

KS009

RECRUITING

Research Site 8204-0, Seongnam-si

03080

RECRUITING

Research Site 8207-0, Seoul

06273

RECRUITING

Research Site 8213-0, Seoul

08190

RECRUITING

Research Site 3403-0, Sant Cugat del Vallès

08003

RECRUITING

Research Site 3410-0, Barcelona

08023

RECRUITING

Research Site 3402-0, Barcelona

08036

RECRUITING

Research Site 3404-0, Barcelona

01230

RECRUITING

Research Site 9001-0, Adana

06010

RECRUITING

Research Site 9002-0, Ankara

06100

RECRUITING

Research Site 9006-0, Ankara

06105

RECRUITING

Research Site 9003-0, Ankara

06800

RECRUITING

Research Site 9004-0, Ankara

TR1 3LJ

RECRUITING

Research Site 4404-0, Truro

EC1A 7BE

RECRUITING

Research Site 4408-0, London

NW1 2PG

RECRUITING

Research Site 4411-0, London

SE1 9RT

RECRUITING

Research Site 4406-0, London

SW36JJ

RECRUITING

Research Site 4416-0, London

W1G 6AD

RECRUITING

Research Site 4409-0, London

M20 4BX

RECRUITING

Research Site 4402-0, Manchester

ME16 9QQ

RECRUITING

Research Site 4415-0, Maidstone

BA1 3NG

RECRUITING

Research Site 4414-0, Bath

CF14 2TL

RECRUITING

Research Site 4410-0, Cardiff

G12 0YN

RECRUITING

Research Site 4405-0, Glasgow

SM2 5PT

RECRUITING

Research Site 4416-A, Sutton

LS9 7TF

RECRUITING

Research Site 4407-0, Leeds

HA6 2RN

RECRUITING

Research Site 4403-0, Middlesex

NG5 1PB

RECRUITING

Research Site 4401-0, Nottingham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BioNTech SE

INDUSTRY

lead

DualityBio Inc.

INDUSTRY

NCT06018337 - A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) | Biotech Hunter | Biotech Hunter