^
    1d
    Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib (clinicaltrials.gov)
    P2, N=60, Recruiting, University of Texas Southwestern Medical Center | Trial primary completion date: Apr 2026 --> Apr 2027
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR positive
    |
    HercepTest
    |
    Verzenio (abemaciclib) • letrozole
    1d
    STU-2021-0657: CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer (clinicaltrials.gov)
    P1, N=30, Recruiting, University of Texas Southwestern Medical Center | Trial completion date: Apr 2026 --> Apr 2029 | Trial primary completion date: Apr 2026 --> Apr 2028
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative • PD-L1 negative
    |
    PD-L1 IHC 22C3 pharmDx • HercepTest
    |
    pegylated liposomal doxorubicin • CDX-1140 • Mobista (CDX-301)
    2ms
    GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort (clinicaltrials.gov)
    P=N/A, N=350, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HercepTest • PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody
    3ms
    GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort (clinicaltrials.gov)
    P=N/A, N=350, Not yet recruiting, AstraZeneca | Trial completion date: Jan 2026 --> Nov 2026 | Initiation date: Aug 2025 --> Apr 2026 | Trial primary completion date: Jan 2026 --> Nov 2026
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    HercepTest • PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody
    3ms
    DF1001-001: Study of DF1001 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=270, Completed, Dragonfly Therapeutics | Recruiting --> Completed | Trial completion date: Dec 2026 --> Dec 2025 | Trial primary completion date: Oct 2026 --> Dec 2025
    Trial completion • Trial completion date • Trial primary completion date • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 negative • HER-2 mutation • HER-2 positive + HER-2 overexpression
    |
    HercepTest
    |
    Opdivo (nivolumab) • albumin-bound paclitaxel • Trodelvy (sacituzumab govitecan-hziy) • DF1001
    5ms
    Differences of HER2 Status by HercepTest and PATHWAY 4B5 Immunohistochemical Assays in Breast Cancer. (PubMed, Anticancer Res)
    HER2 staining was lower in 4B5 testing than in the HercepTest. Companion diagnosis using 4B5 is required to determine indications for T-DXd, especially for HER2-ultralow evaluations.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HercepTest • PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    7ms
    Interassay Comparison With Digital Image Analysis of Four Routine HER2 Immunohistochemistry Assays in Primary Breast Cancer and Its Metastasis. (PubMed, Lab Invest)
    DG44 identified a significantly higher proportion of HER2-(ultra)low cases and showed the most variability in HER2 status between matched primary tumors and metastases compared to 4B5 and SP3. The choice of HER2 assay can lead to discrepancies in HER2 status assessment, which could directly influence patient eligibility for T-DXd treatment.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    HercepTest • PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    9ms
    Quantification of HER2-low and ultra-low expression in breast cancer specimens by quantitative IHC and artificial intelligence. (PubMed, J Pathol Inform)
    The developed methodologies can be used to stratify HER2 low-expression patient groups, potentially improving the interpretation of IHC assays and maximizing therapeutic benefits. This method can be implemented in histology labs without requiring a specialized workflow.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • TP63 (Tumor protein 63)
    |
    HER-2 expression • HER-2 underexpression
    |
    HercepTest
    9ms
    Molecular insights into HER2/ERBB2 amplification and carcinogenesis in gallbladder cancer associated with pancreaticobiliary maljunction. (PubMed, J Gastroenterol)
    This is the first evaluation of HER2/ERBB2 expression in GBC with PBM based on WES, HercepTest, and FISH. The significant increase in ERBB2 expression, driven by the synergistic interplay between GBC and PBM, underscores a critical molecular interaction that may inform the development of targeted therapeutic strategies.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • TYK2 (Tyrosine Kinase 2)
    |
    HER-2 overexpression • HER-2 amplification
    |
    HercepTest
    11ms
    Study on Different Staining Platforms for HER2 Cytoplasmic Granular Staining Pattern in Pure Apocrine Carcinoma of the Breast. (PubMed, Clin Breast Cancer)
    Pure ACs on the PATHWAY 4B5 platform primarily present HER2 cytoplasmic granular staining in TNAC and HER2 low expression cases. The rate of HER2 cytoplasmic granular staining on HercepTest platform was significantly lower than that of PATHWAY 4B5, and is more suitable for the detection and interpretation of HER2 0 and low expression cases.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    HercepTest • PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody
    11ms
    GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort (clinicaltrials.gov)
    P=N/A, N=350, Not yet recruiting, AstraZeneca
    New trial
    |
    HercepTest • PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody
    12ms
    Filling in the Gaps of Examining Human Epidermal Growth Factor Receptor 2 (HER2)-Low and HER2-Ultralow in Breast Cancer: Clone Choice, Sample Size, and Reevaluating Scores Made on Archived Samples. (PubMed, Arch Pathol Lab Med)
    The discordance of HER2 staining depended on the sample size and antibody clone. Tissue stained with 4B5 (CNB or EB), but not with CNB-HercepTest, correlated with mRNA values.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    HercepTest • PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody • Oncotype DX Breast Recurrence Score®Test