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    BIOMARKER:

    HER-2 mutation

    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:
    19h
    Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors (clinicaltrials.gov)
    P1, N=160, Recruiting, SystImmune Inc. | N=120 --> 160
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • CLDN18 (Claudin 18) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    PD-L1 expression • KRAS mutation • MSI-H/dMMR • HER-2 overexpression • BRAF mutation • HER-2 mutation • IDH1 mutation • CLDN18.2 expression • FGFR2 mutation • FGFR2 fusion • IDH mutation + NTRK fusion • NTRK fusion
    4d
    Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan (clinicaltrials.gov)
    P1, N=694, Recruiting, AbbVie | N=512 --> 694 | Trial primary completion date: Jul 2026 --> Jul 2027
    Enrollment change • Trial primary completion date • Adverse events • First-in-human
    |
    PD-1 (Programmed cell death 1)
    |
    BRAF V600E • BRAF V600 • HER-2 mutation
    |
    Avastin (bevacizumab) • budigalimab (ABBV-181) • telisotuzumab adizutecan (ABBV-400)
    4d
    ERBB2 activating mutations and co-occurring genomic alterations contribute to disease heterogeneity in patients with ERBB2-mutant lung cancer. (PubMed, J Thorac Oncol)
    NSCLCs harboring ECD-ERBB2 mutations are associated with a unique clinico-genomic phenotype and improved outcomes with first-line chemoimmunotherapy. These findings have implications for optimizing treatment strategies in this disease.
    Journal • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1) • SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • RBM10 (RNA Binding Motif Protein 10)
    |
    KRAS mutation • EGFR mutation • PIK3CA mutation • HER-2 mutation • STK11 mutation • KEAP1 mutation
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Hernexeos (zongertinib) • Hyrnuo (sevabertinib)
    5d
    Molecular heterogeneity of endometrial cancer in the real-world: Biomarker patterns by tumor stage, histology, and molecular subtype. (PubMed, Gynecol Oncol)
    The results of this real-world study demonstrate that endometrial cancer is a complex disease, characterized by substantial molecular heterogeneity and varying biomarker distributions across histology, stages, and molecular subtypes. This real-world study supports the integration of comprehensive molecular profiling into routine practice to refine prognostic stratification and guide biomarker-driven therapies.
    Journal • Real-world evidence • Tumor mutational burden • MSi-H Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • PTEN (Phosphatase and tensin homolog) • ARID1A (AT-rich interaction domain 1A)
    |
    TP53 mutation • TMB-H • MSI-H/dMMR • HER-2 amplification • PIK3CA mutation • HER-2 mutation • PTEN mutation • ARID1A mutation
    5d
    Final results of the INFINITY precision oncology registry: non-standard targeted treatments in patients with advanced cancers in routine care. (PubMed, ESMO Real World Data Digit Oncol)
    In a tumor-agnostic approach, biomarker-informed NSTT was associated with clinical benefit in 31.7% of the patients, with checkpoint inhibitors being the most common treatment. The INFINITY project demonstrates the feasibility of a large-scale precision oncology project in a community oncology setting and thus supports the implementation of precision oncology into routine clinical practice in Germany.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • HER-2 mutation • HER-2 expression
    6d
    Denosumab is associated with longer real-world progression-free survival in BRCA1/2-mutated HR+ /HER2 - breast cancer patients with bone metastases receiving CDK4/6 inhibitors: A multicenter Italian study. (PubMed, Eur J Cancer)
    In this real-world cohort, denosumab use was associated with longer rwPFS in germline BRCA1/2-mutated HR+/HER2- mBC with bone metastases.
    Clinical • Journal • Real-world evidence • BRCA Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    HER-2 positive • BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 negative • HER-2 mutation • BRCA wild-type • HR positive + HER-2 negative • BRCA mutation • HER-2 negative + HR positive + BRCA mutation
    |
    Prolia (denosumab)
    7d
    SOHO-02: A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2) (clinicaltrials.gov)
    P3, N=444, Recruiting, Bayer | N=177 --> 444
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • Hyrnuo (sevabertinib)
    7d
    Biophysical characterization of recurrent ErbB2 missense mutations reveals alterations in receptor organization and membrane dynamics. (PubMed, J Mol Biol)
    The faster mobility of mutation-activated ErbB2 contrasted with the EGF-induced slowing down of its lateral diffusion. In summary, single amino acid substitutions across ErbB2 domains may modulate receptor dynamics, organization, and responsiveness.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation • EGFR expression
    11d
    Overcoming Trastuzumab-Pertuzumab Resistance and Optimizing Sequential Anti-HER2 Therapy in HER2-Positive Metastatic Breast Cancer. (PubMed, Cancers (Basel))
    Trastuzumab deruxtecan demonstrates substantial antitumor activity through potent cytotoxic effects and a bystander effect, supporting its efficacy in tumors with intratumoral heterogeneity or downstream pathway activation. In contrast, tucatinib-based regimens represent an important option for patients with brain metastases and tumors expressing p95HER2. The ongoing development of novel antibody-drug conjugates and bispecific antibodies is expected to further advance personalized sequential therapy targeting composite resistance mechanisms.
    Review • Journal
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    HER-2 positive • HER-2 mutation • HER-2 expression
    |
    Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Tukysa (tucatinib)
    11d
    Molecular and Microenvironmental Mechanisms of Malignant Transformation in Benign Salivary Gland Tumors: Implications for Oral Squamous Cell Carcinoma. (PubMed, Diagnostics (Basel))
    Benign salivary gland tumors represent a valuable model for studying malignant transformation in head and neck oncology. Interpreting shared molecular and microenvironmental pathways may facilitate the identification of novel biomarkers and support the development of personalized diagnostic and therapeutic approaches for OSCC.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • HMGA2 (High mobility group AT-hook 2) • ENG (Endoglin) • PLAG1 (PLAG1 Zinc Finger)
    |
    TP53 mutation • HER-2 overexpression • HER-2 mutation
    11d
    Real-world Analysis of Treatment Patterns, Clinical Outcomes, and Molecular Profiling in Advanced Biliary Tract Cancer. (PubMed, Anticancer Res)
    The integration of NGS and the subsequent use of matched targeted therapy significantly improved survival outcomes in selected patients with advanced BTC, highlighting the importance of precision medicine strategies.
    Clinical data • Retrospective data • Journal • Real-world evidence • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • ARID1A (AT-rich interaction domain 1A)
    |
    TP53 mutation • KRAS mutation • MSI-H/dMMR • HER-2 amplification • HER-2 mutation • IDH1 mutation • ARID1A mutation • FGFR2 mutation • FGFR2 fusion
    11d
    Magnesium Supplementation in Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2/3, N=230, Not yet recruiting, Swiss Cancer Institute | Initiation date: Dec 2025 --> Jul 2026
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • CD4 (CD4 Molecule)
    |
    BRAF V600E • HER-2 amplification • BRAF V600 • HER-2 mutation • RET mutation • RET rearrangement