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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:
    11h
    MONARCH plus: A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer (clinicaltrials.gov)
    P3, N=463, Active, not recruiting, Eli Lilly and Company | Trial completion date: Jan 2027 --> Mar 2028
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 overexpression • HER-2 negative
    |
    Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole
    14h
    PRELUDE: A Prospective, Multicenter Registry to Observe the Treatment Patterns, Clinical Outcomes, and Decision-Making in Patients With Early Breast Cancer Eligible for EndoPredict® Testing (clinicaltrials.gov)
    P=N/A, N=2000, Recruiting, National and Kapodistrian University of Athens
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    EndoPredict®
    14h
    A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (clinicaltrials.gov)
    P1, N=136, Recruiting, Genentech, Inc. | Trial completion date: Jul 2029 --> Apr 2030 | Trial primary completion date: Jul 2029 --> Apr 2030
    Trial completion date • Trial primary completion date • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    giredestrant (RG6171) • omeprazole
    15h
    An Open-label, First-in-Human, Dose-Escalation and Dose-Expansion Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPR1020 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=210, Recruiting, Shanghai SciBrunch Therapeutics Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D)
    |
    HER-2 negative • HRD • PALB2 mutation • RAD51C mutation • BRCA mutation
    16h
    Testing Low Dose Tamoxifen for Invasive Breast Cancer, the (LoTam) Trial (clinicaltrials.gov)
    P3, N=1156, Suspended, Alliance for Clinical Trials in Oncology | Recruiting --> Suspended
    Trial suspension
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • Oncotype DX Breast Recurrence Score®Test
    |
    tamoxifen • letrozole • anastrozole • exemestane
    17h
    Real-world use and survival outcomes of sacituzumab govitecan in metastatic triple-negative breast cancer and hormone receptor-positive/HER2-negative metastatic breast cancer. (PubMed, Br J Cancer)
    The study highlights SG's clinical relevance and the challenge of translating trial efficacy into real-world outcomes, reinforcing the need for further investigation of tolerability in broader populations.
    Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Trodelvy (sacituzumab govitecan-hziy)
    17h
    The utilization of CEUS and SWE for predicting pathological complete response to neoadjuvant chemotherapy for invasive breast cancer. (PubMed, Sci Rep)
    The combination of ΔDCEUS% and ΔEmax% demonstrated superior predictive ability for NAC response, with an area under the curve (AUC) of 0.906, outperforming ΔDCEUS% (AUC 0.871) or ΔEmax% (AUC 0.722) alone. CEUS combined with SWE shows promise for predicting pCR in invasive breast cancer undergoing NAC.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • ER negative
    20h
    A Study Evaluating the Immunotherapy Treatment for Ovarian Cancer and Other Advanced Malignancies. (clinicaltrials.gov)
    P1/2, N=24, Not yet recruiting, University of Chicago
    New P1/2 trial
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CTAG1B (Cancer/testis antigen 1B)
    |
    HER-2 positive • ER positive • EGFR mutation • BRAF mutation • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    cyclophosphamide • decitabine • Proleukin (aldesleukin)
    20h
    IMPULSE: Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice (clinicaltrials.gov)
    P=N/A, N=240, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting | Trial completion date: Jul 2029 --> Dec 2029 | Initiation date: Jul 2025 --> Jan 2026 | Trial primary completion date: Jul 2029 --> Dec 2029
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Kisqali (ribociclib) • letrozole • anastrozole
    1d
    Estimating the number of people living with metastatic breast cancer: a population-based retrospective cohort study using linked health data. (PubMed, Lancet Reg Health West Pac)
    S.J.L. received funding from an NHMRC Project Grant ID: 1125433.
    Retrospective data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    1d
    ROSETTA GI 204: A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204) (clinicaltrials.gov)
    P2/3, N=690, Recruiting, Bristol-Myers Squibb | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative
    |
    Opdivo (nivolumab) • 5-fluorouracil • pumitamig (BNT327)
    1d
    Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma. (clinicaltrials.gov)
    P3, N=752, Not yet recruiting, Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    HER-2 negative • HER-2 expression • CLDN18.2 positive • CLDN1 positive
    |
    Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • tecotabart vedotin (LM-302)