A Phase III, Multicenter, Open-label, Randomized Study to Compare DB-1303 Versus T-DM1 in Patients With HER2-positive Unresectable/Metastatic Breast Cancer Who Have Been Treated With Trastuzumab and a Taxane (Dynasty-Breast01)
Status: Recruiting
Location: See all (48) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study is designed to compare efficacy and safety of DB-1303/BNT323 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female adults ≥ 18 years at the time of voluntary signing of informed consent.
• Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane
• Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1.
• Presence of at least one measurable lesion according to RECIST v1.1
• Expected survival time ≥ 12 weeks.
• Patients must give informed consent to this study and voluntarily sign written informed consent form prior to the study.
Locations
Other Locations
China
045
RECRUITING
Baoding
001
RECRUITING
Beijing
010
RECRUITING
Beijing
015
RECRUITING
Bengbu
040
RECRUITING
Binzhou
008
RECRUITING
Changchun
030
RECRUITING
Changsha
007
RECRUITING
Chengdu
032
RECRUITING
Dalian
036
RECRUITING
Fuzhou
023
RECRUITING
Guangzhou
024
RECRUITING
Guangzhou
026
RECRUITING
Guangzhou
020
RECRUITING
Haerbin
043
RECRUITING
Haikou
019
RECRUITING
Hangzhou
025
RECRUITING
Hangzhou
042
RECRUITING
Hangzhou
016
RECRUITING
Hefei
029
RECRUITING
Hefei
028
RECRUITING
Huizhou
038
RECRUITING
Jilin
031
RECRUITING
Jinan
047
RECRUITING
Jinan
033
RECRUITING
Kunming
012
RECRUITING
Linyi
018
RECRUITING
Luoyang
014
RECRUITING
Nanchang
004
RECRUITING
Nanjing
027
RECRUITING
Nanjing
017
RECRUITING
Nanning
022
RECRUITING
Nanning
041
RECRUITING
Neijiang
002
RECRUITING
Shanghai
046
RECRUITING
Shanghai
048
RECRUITING
Shijiazhuang
035
RECRUITING
Taiyuan
021
RECRUITING
Tianjin
013
RECRUITING
Ürümqi
009
RECRUITING
Wuhan
011
RECRUITING
Wuhan
003
RECRUITING
Xi’an
037
RECRUITING
Xiamen
044
RECRUITING
Xuzhou
039
RECRUITING
Yantai
034
RECRUITING
Yibin
005
RECRUITING
Zhengzhou
006
RECRUITING
Zhengzhou
Contact Information
Primary
Ren Yue
ren.yue@dualitybiologics.com
+862126018730
Time Frame
Start Date: 2024-01-29
Estimated Completion Date: 2026-02
Participants
Target number of participants: 224
Treatments
Experimental: DB-1303/BNT323
Enrolled patients will receive DB-1303/BNT323 by intravenous (I.V.) infusion
Experimental: T-DM1
Enrolled patients will receive T-DM1 by I.V. infusion
Related Therapeutic Areas
Sponsors
Leads: DualityBio Inc.
Collaborators: BioNTech SE