^
    Back
    Association details:
    Biomarker:HER-2 positive
    Cancer:HER2 Positive Breast Cancer
    Drug:BNT323 (Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

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

    Excerpt:
    ...3) Was never previously reported as HER2-positive (IHC 3+ or ISH+) as per ASCO/CAP guidelines....
    Trial ID:
    DYNASTY-Breast02
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2023
    Title:

    Safety and efficacy of DB-1303 in patients with advanced/metastatic solid tumors: A multicenter, open-label, first-in-human, phase 1/2a study.

    Published date:
    05/25/2023
    Excerpt:
    Among all the pts, the DCR was 88.5% (46/52); for pts with HER2+ BC and HER2-low BC, the DCRs were 96.2% (25/26) and 84.6% (11/13), respectively....DB-1303 was well tolerated with encouraging preliminary antitumor activity in heavily pretreated pts with advanced/metastatic solid tumors, especially in pts with HER2+ BC and brain metastasis as well as in HER2-low BC….
    DOI:
    10.1200/JCO.2023.41.16_suppl.3023
    Trial ID:
    NCT05150691