A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
Trial status:Recruiting
Trial ID:
DB-1303-O-3002
NCT ID:
EudraCT ID:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
DualityBio Inc.
Recruiting
Trial Details
The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (immunohistochemistry \[IHC\]2+/in situ hybridization \[ISH\]- and IHC 1+) population.
Medical Condition
Trial Drug
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Phase
Phase 3
Type
Interventional
Estimated Enrolment
532
Estimated Trial Date
Jan 2024 - May 2026
Trial Participant Requirements
Age
18+ years
Sex
Female & Male
Healthy Volunteers
No
Trial Locations
Location
Status
Location
Research Site 1141-0
Tucson, Arizona, United States, 85704
Status
Recruiting
Location
Research Site 1114-0
Fullerton, California, United States, 92835
Status
Recruiting
Location
Research Site 1107-0
Los Angeles, California, United States, 90095
Status
Recruiting
Location
Research Site 1118-0
Orange, California, United States, 92868-3201
Status
Recruiting
Location
Research Site 1143-0
Sacramento, California, United States, 95814
Status
Recruiting
Location
Research Site 1132-0
Santa Barbara, California, United States, 93105
Status
Recruiting