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    BIOMARKER:

    HER-2 amplification

    i
    Other names: ERBB2, CD340, HER-2, HER2, NEU, NGL, V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2
    Entrez ID:
    2064
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Related tests:
    17h
    HER2 protein expression and gene status in endometrial serous carcinoma (PubMed, Zhonghua Bing Li Xue Za Zhi)
    Both HER2 IHC positive (3+) and FISH positive occur exclusively in pure USC tumors. HER2 gene amplification can be observed in any HER2 IHC levels.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 expression
    1d
    A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer (clinicaltrials.gov)
    P3, N=246, Active, not recruiting, R-Pharm
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    2d
    Exploring the spectrum of HER2 in non-metastatic triple negative breast cancer: from HER2-Null to HER2-low, including HER2-ultralow status. (PubMed, Virchows Arch)
    Despite some significantly different clinicopathological features, there is no solid evidence to support HER2-ultralow, HER2-low and HER2-null cancers as individual TNBC clinical-molecular entities. Particularly, assigning TNBC samples to the HER2-null, -ultralow and -low categories did not bring any additional prognostic value.
    Journal • BRCA Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • PTEN (Phosphatase and tensin homolog) • CD20 (Membrane Spanning 4-Domains A1) • CD163 (CD163 Molecule)
    |
    PD-L1 expression • HER-2 amplification • HER-2 negative
    2d
    PD-1 blockade elicits a systemic immune response but not in the tumor of TNBC mice. (PubMed, Acta Biochim Biophys Sin (Shanghai))
    In addition, PD-1 blockade does not rescue the hematopoietic damage caused by TNBC, highlighting a limitation in long-term response. Furthermore, PD-1 blockade in tumor-free mice leads to an increase in hematopoietic stem/progenitor cells, suggesting that PD-1 blockade may yield better benefits post-tumor resection.
    Preclinical • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification
    2d
    Molecular Advances in Gastrointestinal Pathology. (PubMed, Semin Diagn Pathol)
    Combining biomarker-driven immunotherapy and targeted approaches such as PD-1 blockade in MSI-H or EBV-positive tumors, HER2-directed therapy, and CLDN18.2 inhibition, has demonstrated a paradigm shift in the clinical management. This review highlights a pathologist-centered perspective on molecularly defined subgroups, actionable biomarkers, and evolving therapeutic paradigms in CRC and GEJ carcinoma, advancing precision oncology.
    Review • Journal • Tumor mutational burden • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • CLDN18 (Claudin 18) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    PD-L1 expression • TMB-H • MSI-H/dMMR • KRAS G12C • HER-2 amplification • PIK3CA mutation • HER-2 expression • KRAS G12
    3d
    Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors (clinicaltrials.gov)
    P1, N=280, Recruiting, SystImmune Inc. | Trial completion date: Aug 2027 --> Apr 2029 | Trial primary completion date: Dec 2025 --> Dec 2028
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 mutation • HER-2 expression
    |
    trastuzumab brengitecan (BL-M07D1)
    4d
    Cytotoxic and immunomodulatory activity of CD151-LEL-based peptides in breast cancer and THP-1 cells. (PubMed, Hum Immunol)
    Furthermore, conditioned media from the treated BC cells induced the proliferation of PMA treated monocyte like THP-1 cells and provoked the secretion of IL-6, while reducing IL-10. These findings suggest that the CD151-LEL-based peptides and their engineered multiepitope construct represent a prospective vaccine candidate for in vivo experimental validation, which can be used as a therapeutic vaccine for breast cancer.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • CCND1 (Cyclin D1) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • IL2 (Interleukin 2) • IL10 (Interleukin 10) • TLR2 (Toll Like Receptor 2) • CD151 (CD151 Molecule)
    |
    HER-2 amplification • HER-2 expression
    5d
    Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors (clinicaltrials.gov)
    P1, N=48, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension
    |
    CCNE1 (Cyclin E1)
    |
    HER-2 amplification • HER-2 expression
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • azenosertib (ZN-c3)
    5d
    A Study of Tucatinib and Trastuzumab in People With Rectal Cancer (clinicaltrials.gov)
    P2, N=37, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • RAS wild-type • HER-2 positive + HER-2 overexpression • HER-2 positive + RAS wild-type
    |
    Herceptin (trastuzumab) • Tukysa (tucatinib)
    5d
    Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLC (clinicaltrials.gov)
    P=N/A, N=60, Not yet recruiting, The First Affiliated Hospital of Guangzhou Medical University
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation
    |
    Perjeta (pertuzumab) • trastuzumab rezetecan (SHR-A1811)
    6d
    Predictors of Response to Neoadjuvant Therapy in HER2-positive Breast Cancer and Pathological Evaluation of HER2 Heterogeneity. (PubMed, Mod Pathol)
    Higher HER2-HQE is associated with increased RCB. Quantifying HER2 heterogeneity via HQE and percentage of HER2 IHC 3+ may help optimize therapeutic strategies in clinical practice.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification • HER-2 expression
    6d
    A single-center, single-arm, exploratory clinical trial investigating the tolerance, safety, and efficacy of xg0201 for her2-positive breast cancer with brain metastases (ChiCTR2500105266)
    P=N/A, N=3, Suspended, The Third Affiliated Hospital of Zhengzhou University; The Third Affiliated Hospital of Zhengzhou University | Recruiting --> Suspended
    Trial suspension
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 positive + HER-2 overexpression