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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:
    1d
    UCLA B-13: Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer (clinicaltrials.gov)
    P1/2, N=18, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Apr 2027 --> Apr 2028 | Trial primary completion date: Apr 2026 --> Apr 2027 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    HER-2 amplification
    |
    carboplatin • docetaxel • Perjeta (pertuzumab) • Kisqali (ribociclib) • fulvestrant • Tukysa (tucatinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    2d
    CHIMERA: Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer. (clinicaltrials.gov)
    P2, N=42, Recruiting, Gruppo Oncologico del Nord-Ovest
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • CA 19-9 (Cancer antigen 19-9)
    |
    HER-2 overexpression • HER-2 amplification
    |
    Avastin (bevacizumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine
    2d
    OPTIMA-YOUNG: Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests (clinicaltrials.gov)
    P3, N=3380, Not yet recruiting, UNICANCER
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 amplification • HER-2 negative • HER-2 expression
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    4d
    IKS014-01: IKS014 in Advanced Solid Tumors That Express HER2 (clinicaltrials.gov)
    P1, N=165, Recruiting, Iksuda Therapeutics Ltd. | Trial completion date: Sep 2027 --> Dec 2027 | Trial primary completion date: Sep 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 positive • HR positive • HER-2 amplification • HER-2 expression • HER-2 amplification + HR-positive
    |
    caxmotabart entudotin (IKS014)
    4d
    Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy (clinicaltrials.gov)
    P1, N=30, Recruiting, Vanderbilt-Ingram Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 amplification • HER-2 expression
    6d
    Genetic analysis of primary lung interdigitating dendritic cell sarcomas. (PubMed, J Pathol)
    © 2026 The Author(s). The Journal of Pathology published by John Wiley & Sons Ltd on behalf of The Pathological Society of Great Britain and Ireland
    Journal • Tumor mutational burden
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CCNE1 (Cyclin E1) • MTAP (Methylthioadenosine Phosphorylase) • MLH1 (MutL homolog 1) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • MDM4 (The mouse double minute 4) • SMAD2 (SMAD Family Member 2)
    |
    TP53 mutation • HER-2 amplification
    6d
    Determination of the optimal cell count for HER2 status assessment in fluorescence in situ hybridization. (PubMed, Ann Diagn Pathol)
    Stratified analysis revealed that unequivocal cases (Groups 1 + 5, approximately 84% of the cohort) maintained excellent concordance (coefficient of variation <5%) at all tiers, while equivocal cases (Groups 2-4) exhibited persistently higher variability regardless of cell count. These findings validate the 20-cell minimum for routine FISH-based HER2 assessment and demonstrate that enhanced concordance in borderline cases requires adjudicatory workflows beyond additional cell counting.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification • HER-2 negative
    7d
    MEDOPP0776: PHASE?IB/II STUDY TO EVALUATE SAFETY AND PRELIMINARY EFFICACY OF ZANIDATAMAB IN COMBINATION WITH TUCATINIB AND CHEMOTHERAPY (CAPECITABINE OR ERIBULIN MESYLATE) IN HER2-POSITIVE ADVANCED BREAST CANCER (The JAZMINE Study) (2025-524613-89-00)
    P1/2, N=129, Not yet recruiting, Medica Scientia Innovation Research S.L.
    New P1/2 trial
    |
    HER-2 positive • HER-2 amplification
    |
    capecitabine • Halaven (eribulin mesylate) • Tukysa (tucatinib) • dexamethasone • Ziihera (zanidatamab-hrii)
    7d
    The Use of Fam-Trastuzumab Deruxtecan-nxki in Treating ERBB2 Amplified Small Cell Lung Cancer Transformed From Non-Small Cell Lung Cancer: A Case Report. (PubMed, Case Rep Oncol Med)
    We present a case of a 66-year-old female with de novo metastatic NSCLC harboring an EGFR mutation, RET rearrangement, and ERBB2 amplification, who experienced transformation to SCLC while on osimertinib. Subsequently, she exhibited primary refractory disease to both first-line platinum doublet with immunotherapy and second-line lurbinectedin...The patient had minimal side effects and obtained a partial response with a progression-free survival (PFS) of 13.1 months, better than historically poor prognosis seen in transformed SCLC. This case underscores the potential role of human epidermal growth factor receptor 2 (HER-2) directed therapies, such as T-DXd, in transformed SCLC.
    Journal • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • RET (Ret Proto-Oncogene)
    |
    EGFR mutation • HER-2 amplification • RET mutation • RET rearrangement
    |
    Tagrisso (osimertinib) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Zepzelca (lurbinectedin)
    7d
    Comprehensive molecular characterization identifies therapeutic vulnerabilities in ovarian clear cell carcinoma. (PubMed, Genome Med)
    In summary, our study establishes the comprehensive molecular atlas and a targeted therapeutic subtyping framework, revealing therapeutic vulnerabilities and providing novel insights for advancing precision oncology in OCCC management.
    Journal • IO biomarker
    |
    FGFR2 (Fibroblast growth factor receptor 2) • ARID1A (AT-rich interaction domain 1A) • SETD2 (SET Domain Containing 2, Histone Lysine Methyltransferase) • EP300 (E1A binding protein p300) • FOXA2 (Forkhead Box A2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 expression • ARID1A mutation • FGFR2 fusion
    7d
    Integrated DNA and RNA profiling refines prognostic stratification independent of therapeutic actionability in cholangiocarcinoma. (PubMed, BMC Cancer)
    Integrated genomic and transcriptomic profiling refines prognostic stratification in cholangiocarcinoma independent of therapeutic actionability. KRAS-TP53 co-mutation and the Mesenchymal transcriptomic subtype represent independent high-risk markers detectable on routine FFPE tissue. These features complement actionable alterations and may inform patient selection and clinical trial design.
    Journal • MSi-H Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    TP53 mutation • KRAS mutation • MSI-H/dMMR • HER-2 amplification • IDH1 mutation • FGFR2 mutation • FGFR2 fusion
    8d
    DARWIN II: Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity (clinicaltrials.gov)
    P2, N=50, Completed, University College, London | Active, not recruiting --> Completed | Trial completion date: May 2026 --> Nov 2025 | Trial primary completion date: May 2026 --> Nov 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene)
    |
    HER-2 amplification • BRAF V600 • RET fusion • ALK fusion
    |
    Tecentriq (atezolizumab) • Zelboraf (vemurafenib) • carboplatin • Alecensa (alectinib) • Kadcyla (ado-trastuzumab emtansine)