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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
    A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment. (clinicaltrials.gov)
    P3, N=400, Recruiting, Pfizer
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    everolimus • fulvestrant • exemestane • prifetrastat (PF-07248144)
    1d
    A Single-arm, Multicenter Exploratory Clinical Trial of Anlotinib Combined With TQB2450 and the SOX Regimen as First-line Treatment for Advanced Gastric Cancer With Low PD-L1 Expression (clinicaltrials.gov)
    P2, N=37, Active, not recruiting, Yongxu Jia | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2025 --> Jun 2026
    Enrollment closed • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative
    |
    Focus V (anlotinib) • oxaliplatin • Andewei (benmelstobart) • Teysuno (gimeracil/oteracil/tegafur)
    2d
    LaPemERLA: Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole (clinicaltrials.gov)
    P2, N=40, Recruiting, National Cancer Centre, Singapore | Trial completion date: Dec 2027 --> Dec 2028 | Trial primary completion date: Dec 2025 --> Dec 2026
    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 amplification • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • letrozole
    2d
    A Study of Real-World Treatment Patterns and Outcomes Among HR+/HER2- Metastatic Breast Cancer Patients Treated With First-Line CDK4/6 Inhibitors (clinicaltrials.gov)
    P=N/A, N=480, Completed, Novartis Pharmaceuticals
    New trial • HEOR • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    3d
    Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=13, Completed, H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative
    |
    capecitabine • Libtayo (cemiplimab-rwlc)
    3d
    TSL-B2276-1-01: A Study of STRO-002 in Chinese Adults With Epithelial Ovarian Cancer and Other Advanced Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=19, Completed, Tasly Pharmaceutical Group Co., Ltd | Recruiting --> Completed | N=132 --> 19 | Trial completion date: Dec 2027 --> Dec 2025 | Trial primary completion date: Dec 2026 --> Jun 2025
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    luveltamab tazevibulin (STRO-002)
    3d
    A Pilot Study of Tomographic Optical Breast Imaging (DBT-TOBI) to Monitor Response to Neoadjuvant Therapy (clinicaltrials.gov)
    P=N/A, N=30, Active, not recruiting, Massachusetts General Hospital | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 negative • EGFR positive
    3d
    TRIFOUR: Nadunolimab in Combination With Gemcitabine Plus Carboplatin in Patients With Advanced Triple Negative Breast Cancer. (clinicaltrials.gov)
    P1/2, N=117, Active, not recruiting, Cantargia AB | Trial primary completion date: Jun 2025 --> Apr 2026
    Trial primary completion date • BRCA Companion diagnostic • PARP Companion diagnostic
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset) • CD4 (CD4 Molecule)
    |
    BRCA2 mutation • BRCA1 mutation • HER-2 negative • HER-2 negative + HR negative • HER-2 negative + HR negative + BRCA mutation
    |
    PD-L1 IHC 22C3 pharmDx • Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    carboplatin • gemcitabine • nadunolimab (CAN04)
    3d
    HR+/HER2- breast cancer brain metastases treated with definitive local therapy: a focus on endocrine sensitivity and incidence of leptomeningeal disease. (PubMed, Neurooncol Adv)
    Patients with endocrine-sensitive disease at the time of BrM diagnosis had a longer brain-specific progression-free survival (7 mo versus 5 months, P = .004) and overall survival (24 months versus 5 mo, P  = .002) compared with those with endocrine resistance. Most patients with HR+/HER2- BrM have endocrine-resistant disease, with an unexpectedly high likelihood of developing LMD.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    3d
    Capivasertib-Induced Refractory Hyperglycemia in a Nondiabetic Patient With Metastatic Breast Cancer. (PubMed, AACE Endocrinol Diabetes)
    Prompt recognition, intensive management, and drug discontinuation are critical. This is one of the first case reports to describe sustained euglycemia following severe and refractory hyperglycemia due to capivasertib therapy.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Truqap (capivasertib)
    3d
    Auditing shortcut learning and misclassification in artificial intelligence-based breast cancer genomic subtyping. (PubMed, JAMIA Open)
    The pseudo-SHAP method provides a scalable, interpretable auditing framework for detecting shortcut learning in resource-constrained environments. Its application could enhance transparency and equity in AI models for precision oncology.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 negative • HER-2 elevation
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    4d
    Everolimus destabilizes thymidylate synthase via suppressing its O-GlcNAcylation and sensitizes HER2-negative breast cancer to fluorouracil. (PubMed, Cell Death Dis)
    5-Fluorouracil (5-FU) and its prodrugs are widely used drugs for chemotherapy in various cancers. In conclusion, our study reveals that everolimus sensitizes breast cancer to fluoropyrimidines by destabilizing TYMS through modulation of its O-GlcNAcylation. These findings support a promising combination strategy to improve the therapeutic efficacy of 5-FU and capecitabine in breast cancer.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • TYMS (Thymidylate Synthetase) • OGT (O-linked N-acetylglucosamine (GlcNAc) transferase)
    |
    HER-2 negative
    |
    5-fluorouracil • everolimus • capecitabine