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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
    DNADalHR: ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=393, Recruiting, Peking University People's Hospital | Not yet recruiting --> Recruiting
    Enrollment open • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    paclitaxel • docetaxel • cyclophosphamide • exemestane • AiRuiKang (dalpiciclib)
    1d
    Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients (BCTOP-T-A03) (clinicaltrials.gov)
    P3, N=764, Recruiting, Fudan University | N=548 --> 764
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    albumin-bound paclitaxel • cyclophosphamide
    1d
    Chemical constituents of Rhazya stricta as potential Aurora kinase A inhibitors for targeting HER2-negative breast cancer: an integrated in-silico and in-vitro study. (PubMed, BMC Complement Med Ther)
    Compounds (6), (8), (5), (4), (1) as AURKA inhibitors have the potential to block AURKA by targeting p53 tumor-suppressing protein to prevent the further development of tumors. The MTT assay was performed to confirm the cell viability, cell inhibition, and cytotoxicity of the phytochemicals present in the plant extract.
    Preclinical • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • AURKA (Aurora kinase A)
    |
    HER-2 overexpression • HER-2 negative
    1d
    PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) (clinicaltrials.gov)
    P2, N=297, Recruiting, Kristina A. Fanucci | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CD4 (CD4 Molecule)
    |
    ER positive • HER-2 negative • ESR1 mutation • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    |
    capecitabine • Orserdu (elacestrant)
    1d
    Testing the Addition of an Anti-cancer Drug, Berzosertib, to the Usual Treatment (Radiation Therapy) for Chemotherapy-Resistant Triple-Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer (clinicaltrials.gov)
    P1, N=42, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: Apr 2026 --> Feb 2027 | Trial completion date: Apr 2026 --> Feb 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    berzosertib (M6620)
    1d
    PIKASSO-01: A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (clinicaltrials.gov)
    P1, N=193, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2025 --> Dec 2026 | 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) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    paclitaxel • Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole • exemestane • Inluriyo (imlunestrant) • LOXO-783
    2d
    The evolution and prognostic impact of HER2-low, HER2-ultralow, and HER2-null status in HER2-negative early breast cancer: A pre- to post-neoadjuvant chemotherapy study. (PubMed, Cancer)
    HER2 expression levels (low/ultralow/null) stratify prognosis in HER2-negative eBC. The dynamic evolution of HER2 status following NAC and its prognostic utility highlights the importance of reassessing HER2 status in residual disease in HER2-negative eBC.
    Retrospective data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative • HER-2 expression • HR negative
    2d
    Optimizing Workflow for OncotypeDX Result Turnaround Time at a Safety Net Hospital. (PubMed, Glob J Qual Saf Healthc)
    We developed a strategy to optimize the OncotypeDX workflow in a large safety net health system despite an increase in patients from MUAs and MUPs. Initiating ordering of OncotypeDX by breast surgery, along with communication with pathology, vendor, and medical oncology, significantly reduced TAT.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Oncotype DX Breast Recurrence Score®Test
    2d
    Cost-effectiveness analysis of inavolisib combined with palbociclib plus fulvestrant in PIK3CA-mutated HR+/Her2- advanced breast cancer in China. (PubMed, Front Pharmacol)
    While inavolisib plus palbociclib-fulvestrant significantly prolongs PFS and OS in PIK3CA-mutated HR+/HER2- ABC/MBC, it is not cost-effective at current prices in China. Strategic price adjustments or reimbursement negotiations are essential to improve economic feasibility and inform clinical and policy decisions.
    Journal • HEOR • Cost-effectiveness
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    EGFR mutation • HR positive • HER-2 negative • PIK3CA mutation • EGFR positive
    |
    Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)
    2d
    Causality between immune cells and HER2-breast cancer: A 2‑sample Mendelian randomization study. (PubMed, Medicine (Baltimore))
    This study showed that the immune response affects the progress of HER2-BC in a complex mode. These findings greatly improve our understanding of the interaction between immune response and HER2-BC risk, and also help to design therapeutic strategies for HER2-BC from the perspective of immunology.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • CD4 (CD4 Molecule) • HLA-DRA (Major Histocompatibility Complex, Class II, DR Alpha)
    |
    HER-2 negative
    2d
    LBC-Monitor: Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA in Metastatic Lobular Breast Cancer (clinicaltrials.gov)
    P=N/A, N=20, Recruiting, Julia Foldi | Trial completion date: Oct 2026 --> Oct 2029 | Trial primary completion date: Oct 2026 --> Oct 2029
    Trial completion date • Trial primary completion date • Liquid biopsy • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Signatera™
    2d
    Neoadjuvant Chemotherapy With WH002 in Women With HER2-negative Breast Cancer (clinicaltrials.gov)
    P1, N=40, Completed, Beijing Wehand-Bio Pharmaceutical Co., Ltd | Not yet recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    paclitaxel • cyclophosphamide • epirubicin