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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:
    22h
    Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy (clinicaltrials.gov)
    P2, N=46, Recruiting, University of Nebraska | Trial completion date: Sep 2031 --> Sep 2032 | Trial primary completion date: Sep 2025 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Ibrance (palbociclib)
    23h
    Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis (clinicaltrials.gov)
    P2, N=16, Recruiting, Wake Forest University Health Sciences | Trial primary completion date: Dec 2025 --> May 2026
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 negative • ER negative • HER-2 negative + AR positive + ER positive
    |
    methotrexate IV
    1d
    Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
    P3, N=228, Recruiting, Sun Yat-sen University | Trial completion date: Dec 2025 --> Jul 2026 | Trial primary completion date: Jul 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • ER negative
    |
    carboplatin • gemcitabine
    2d
    HER2 expression in breast cancer: evidence gaps and challenges. (PubMed, NPJ Precis Oncol)
    This evolving landscape challenges the traditional use of HER2 as a diagnostic marker and underscores the need for a deeper understanding of HER2 biology. This review addresses these complexities, focusing on the emerging HER2-Low and Ultralow subtypes, and evaluates the distinct therapeutic responses across the spectrum of HER2 expression in different BC subtypes.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative • HER-2 expression
    2d
    Sequencing antibody-drug conjugates in metastatic breast cancer: A systematic review. (PubMed, Cancer Treat Rev)
    Emerging evidence indicates that sequential ADC use can be effective despite some cross-resistance, especially when distinct payload mechanisms are employed. Clinical use should consider payload type, timing, and breast cancer subtype, but toxicities remain critical for decision-making. Research providing insights into resistance mechanisms and biomarkers is needed for personalized approaches.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki)
    2d
    FOURLIGHT-1: A Study to Learn About the Study Medicine Called PF-07220060 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)
    P2, N=333, Active, not recruiting, Pfizer | Trial primary completion date: Sep 2025 --> Mar 2026
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    everolimus • fulvestrant • exemestane • atirmociclib (PF-07220060)
    3d
    MORPHEUS-EC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer) (clinicaltrials.gov)
    P1/2, N=214, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed | N=410 --> 214
    Trial completion • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    HER-2 negative • HER-2 expression
    |
    cisplatin • Tecentriq (atezolizumab) • paclitaxel • 5-fluorouracil • Cotellic (cobimetinib) • Cyramza (ramucirumab) • oxaliplatin • leucovorin calcium • tiragolumab (RG6058) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide)
    3d
    The role of circulating tumor cell-associated genes in the progression of estrogen receptor-positive breast cancer. (PubMed, NPJ Breast Cancer)
    Higher CTC signature ITH was associated with increased Oncotype DX risk and higher overall grade. These findings highlight the value of our CTC signature in disease progression and the role of ITH on recurrence risk.
    Journal • Circulating tumor cells
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • EGFR positive • EGFR negative
    |
    Oncotype DX Breast Recurrence Score®Test
    3d
    NCI-2018-01581: Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=70, Recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2025 --> Dec 2026 | Trial primary completion date: Nov 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD4 (CD4 Molecule)
    |
    HER-2 negative • PD-L1 negative
    |
    carboplatin • Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • Imjudo (tremelimumab-actl) • Trodelvy (sacituzumab govitecan-hziy) • Hiltonol (poly-ICLC)
    3d
    Ultrasound-detected gastric changes related to zolbetuximab-induced emesis: a case series. (PubMed, Front Oncol)
    These observations suggest that gastric wall changes detectable using US are closely linked to nausea and may reflect underlying gastric injury. This report also highlights the potential of bedside US monitoring to help predict and prevent nausea during zolbetuximab therapy.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 negative • CLDN18.2 positive • HER-2 negative + CLDN18.2 positive
    |
    Vyloy (zolbetuximab-clzb)
    3d
    Conversion surgery following zolbetuximab-based chemotherapy for CLDN18.2-positive gastroesophageal junction cancer. (PubMed, Int Cancer Conf J)
    The patient was treated with six cycles of zolbetuximab-CAPOX (zolbetuximab, capecitabine, and oxaliplatin), resulting in complete regression of liver metastases and significant tumor shrinkage. Additionally, transient treatment-related gastritis observed during therapy raises questions about the effects of CLDN18.2 inhibition on gastric mucosal integrity. Further research is warranted to refine patient selection for CLDN18.2-targeted therapy and investigate its broader physiological effects.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 negative • CLDN18.2 positive
    |
    capecitabine • oxaliplatin • Vyloy (zolbetuximab-clzb)
    3d
    Anlotinib or Bevacizumab Combined with Taxane/Capecitabine for the Second-Line or Subsequent Treatment of HER-2 Negative Metastatic Breast Cancer: A Retrospective Cohort Study. (PubMed, Drug Des Devel Ther)
    This regimen was associated with improved DCR, PFS, and OS compared to bevacizumab plus chemotherapy in patients with HER2-negative MBC. These findings suggest that anlotinib may represent a promising therapeutic option for patients for whom ADC drugs are inaccessible or unsuitable; however, further prospective, randomized studies are warranted to confirm.
    Retrospective data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Avastin (bevacizumab) • Focus V (anlotinib) • capecitabine