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    BIOMARKER:

    HER-2 expression

    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
    A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ (clinicaltrials.gov)
    P1, N=43, Recruiting, Mayo Clinic | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    1d
    Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06) (clinicaltrials.gov)
    P1/2, N=210, Recruiting, Merck Sharp & Dohme LLC | Trial primary completion date: Dec 2026 --> May 2028
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    HER-2 expression
    |
    Keytruda (pembrolizumab) • paclitaxel • Cyramza (ramucirumab) • patritumab deruxtecan (U3-1402) • Jiataile (sacituzumab tirumotecan)
    1d
    A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) (clinicaltrials.gov)
    P3, N=541, Active, not recruiting, DualityBio Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • mTOR (Mechanistic target of rapamycin kinase)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    capecitabine • albumin-bound paclitaxel • trastuzumab pamirtecan (BNT323)
    2d
    TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor (CAR) T Cells for the Treatment of Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=27, Not yet recruiting, Baylor College of Medicine | Trial completion date: Sep 2034 --> Jan 2044 | Trial primary completion date: Sep 2028 --> Jan 2029
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    2d
    ESR-21-21447: Trastuzumab Deruxtecan (T-DXd): Tailoring Treatment and Companion Diagnostics (CDx) by Liquid Biopsy. DIAMOND STUDY (2024-518017-26-00)
    P1/2, N=22, Active, not recruiting, Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting --> Active, not recruiting
    Enrollment closed • Liquid biopsy • Companion diagnostic
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    3d
    Trastuzumab Rezetecan in Human Epidermal Growth Factor Receptor 2-Expressing Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: A Multicenter, Open-Label, Phase I Trial. (PubMed, J Clin Oncol)
    Trastuzumab rezetecan showed tolerable safety and preliminary efficacy in HER2-expressing advanced GC/GEJ and CRC.
    P1 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811)
    3d
    HER2-Specific Synthetic Antigen Receptor (SAR) T Cell Therapy Synergizes with Radiotherapy to Provide Improved Anti-Tumor Efficacy in Non-Small Cell Lung Cancer (NSCLC). (PubMed, J Leukoc Biol)
    Induction radiotherapy enhances HER2-SAR T cell infiltration and provides synergistic tumor suppression, likely through additional activation of immune-mediated apoptosis. These findings support further assessment of HER2-SAR T cell therapy in HER2-expressing NSCLC.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CASP3 (Caspase 3)
    |
    HER-2 expression
    4d
    AdheRA: Evaluation of Adherence to Cell Cycle Inhibitors Used as Adjuvant Therapy in Patients With Localized Breast Cancer at High Risk of Recurrence. (clinicaltrials.gov)
    P=N/A, N=81, Not yet recruiting, University Hospital, Grenoble
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 amplification • HER-2 negative • HER-2 expression • HR positive + HER-2 negative • HER-2 negative + ER positive
    7d
    Disease control with disitamab vedotin in HER2-low polymorphous adenocarcinoma of the tongue base after chemotherapy failure: A case report. (PubMed, Oral Oncol)
    The tumor progressed after two cycles of first-line induction chemotherapy with paclitaxel plus cisplatin. The response to disitamab vedotin, despite prior taxane progression, suggests the potential critical role of HER2-mediated drug delivery and indicates that low antigen density may be sufficient for ADC efficacy. This case indicates the importance of routine HER2 testing with explicit HER2-low categorization in advanced SGCs and offers preliminary evidence that may help expand therapeutic options for this treatment-refractory population.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression • HER-2 underexpression
    |
    cisplatin • paclitaxel • Aidixi (disitamab vedotin)
    7d
    TBCRC 041: Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer (clinicaltrials.gov)
    P2, N=96, Completed, Mayo Clinic | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 amplification • HER-2 negative • HER-2 expression • ER negative • HER-2 negative + ER positive
    |
    fulvestrant • alisertib (MLN8237)
    7d
    DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] (clinicaltrials.gov)
    P3, N=608, Completed, Daiichi Sankyo | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    lapatinib • Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine