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
Study Identifier:
DB-1303-O-3002
ClinicalTrials.gov Identifier:
NCT06018337
EudraCT Identifier:
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

Medical Condition
  • Breast Cancer
    • Study Drug
  • Drug: DB-1303/BNT323
  • Drug: Capecitabine
  • Drug: Paclitaxel
    • See more
  • Drug: Nab-paclitaxel
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+
    Estimated Trial Date
    Jan 2024 - Dec 2025

    Protocol summary

    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.

    Trial locations

    Location
    Status
    Location
    Research Site
    Tucson, Arizona, United States, 85704
    Status
    Recruiting
    Location
    Research Site
    Fullerton, California, United States, 92835
    Status
    Recruiting
    Location
    Research Site
    Santa Barbara, California, United States, 93105
    Status
    Recruiting
    Location
    Research Site
    Lone Tree, Colorado, United States, 80124
    Status
    Recruiting
    Location
    Research Site
    Palm Bay, Florida, United States, 32909
    Status
    Recruiting
    Location
    Research Site
    Savannah, Georgia, United States, 31405
    Status
    Recruiting