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    BIOMARKER:

    HER-2 negative

    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
    Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Gilead Sciences
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    PD-L1 expression • HER-2 negative
    |
    Opdivo (nivolumab) • paclitaxel • Cyramza (ramucirumab) • denikitug (GS-1811)
    1d
    CDKN1B inactivation impacts ER signaling and drives resistance to endocrine therapy in breast cancer. (PubMed, Br J Cancer)
    Our results highlight CDKN1B as a prognostic biomarker to guide CDK4/6-targeted therapy and a predictor of endocrine resistance in HR + /HER2- breast cancer.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CDKN1B (Cyclin dependent kinase inhibitor 1B)
    |
    HR positive • HER-2 negative
    |
    tamoxifen • fulvestrant
    1d
    Targeting cyclin-dependent kinases in cancer: emerging therapeutics and clinical strategies. (PubMed, Trends Cancer)
    Several of these candidates have entered early-phase clinical evaluation, marking a new era in CDK-targeted therapy. This review synthesizes recent preclinical and clinical advances, defines key challenges in optimizing efficacy and safety, and outlines future directions for integrating CDK-directed strategies within precision oncology frameworks.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • EGFR positive
    1d
    Peripheral blood transcriptional profiling predicts tumor subtype and neoadjuvant chemoimmunotherapy outcomes in human breast cancer. (PubMed, Sci Transl Med)
    We developed a multiparametric peripheral immune biomarker that integrated baseline and early on-treatment features to predict response to pembrolizumab, which was successfully validated in an independent cohort of 59 patients with breast cancer treated with neoadjuvant dostarlimab. These findings reveal the potential of blood-based immune monitoring to predict immunotherapy benefit, offering an accessible tool for tailoring treatment strategies in breast cancer.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • Jemperli (dostarlimab-gxly)
    1d
    Human Epidermal Growth Factor Receptor 2 Expression in Prostatic Carcinomas: A Systematic Review and Meta-Analysis of a Potential Therapeutic Target. (PubMed, Prostate)
    HER2 overexpression is rare in prostatic carcinomas but nearly half show HER2 expression of Score 1 or above. Cases with higher Gleason score and advanced disease stage are more likely to overexpress HER2.
    Retrospective data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 negative
    1d
    Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer (clinicaltrials.gov)
    P3, N=246, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Active, not recruiting --> Recruiting | Trial completion date: Mar 2031 --> Jun 2029 | Trial primary completion date: Sep 2030 --> Dec 2028
    Enrollment open • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • ER negative • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Halaven (eribulin mesylate)
    1d
    MIRINAE: Efficacy and Safety of Atezolizumab Plus Capecitabine Adjuvant Therapy for Triple Receptor-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=284, Active, not recruiting, National Cancer Center, Korea | Trial completion date: Jan 2027 --> Dec 2027 | Trial primary completion date: Jan 2024 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    PD-L1 expression • HER-2 negative
    |
    Tecentriq (atezolizumab) • capecitabine
    1d
    Role of Axillary Lymph Node Dissection for Residual MACROMETASTASES After NEOADJUVANT Chemotherapy in Patients With HER2+ and Triple Negative Breast Cancer: The OPBC-11/MACRONAC Study (clinicaltrials.gov)
    P=N/A, N=600, Active, not recruiting, University Hospital, Basel, Switzerland
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 negative • HER-2 expression
    1d
    GEMINI-PeriOp GC: A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (clinicaltrials.gov)
    P2, N=100, Recruiting, AstraZeneca
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 positive • HER-2 negative • CLDN18.2 positive • CLDN18.2 positive + HER-2 negative
    |
    docetaxel • 5-fluorouracil • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • oxaliplatin • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936)
    1d
    A Phase I Dose-Escalation Clinical Study Evaluating Stiripentol Combined with Immunochemotherapy for the Treatment of HER2-Negative Unresectable Advanced Gastric Cancer (ChiCTR2600121591)
    P1, N=30, The Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen); The Seventh Affiliated Hospital of Sun Yat-sen University
    New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 negative
    |
    capecitabine • oxaliplatin
    2d
    Efficacy and Mechanism of Camrelizumab in Combination with Risedronate and Chemotherapy for Triple-Negative Breast Cancer: An Exploratory Clinical Study (ChiCTR2600120465)
    P=N/A, N=30, Harbin Medical University Cancer Hospital; Harbin Medical University Cancer Hospital
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    AiRuiKa (camrelizumab)
    2d
    To evaluate the safety and efficacy of Apololitowereili Monoclonal Antibody combined with FLOT regimen in patients with locally advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma. (ChiCTR2600120362)
    P2, N=29, Fuzhou University Affiliated Provincial Hospital; Fuzhou University Affiliated Provincial Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    PD-L1 expression • HER-2 negative
    |
    apalutamide