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    BIOMARKER:

    HER-2 negative + ER positive

    i
    Other names: ERBB2, CD340, HER-2, HER2, NEU, NGL, V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2; ESR1, Era, ESR, NR3A1, ER, ER beta
    Entrez ID:
    2064; 2099
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Associations

    News

    Trials
    3d
    SUMIT-ELA: A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=49, Completed, Carrick Therapeutics Limited | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • CDK4 (Cyclin-dependent kinase 4)
    |
    TP53 mutation • ER positive • HER-2 negative • ESR1 mutation • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    |
    Orserdu (elacestrant) • samuraciclib (CT7001)
    6d
    A Comparative Analysis of the Utility of Nottingham Prognostic Index and Ki-67 in Selecting ER-positive HER2-negative Patients for Oncotype DX Testing. (PubMed, Clin Breast Cancer)
    NPI, using a threshold of 3.4 as recommended by NICE, may assist in identifying patients for whom Oncotype DX testing could be considered. Ki-67 may provide additional prognostic context when interpreted alongside NPI. These markers may contribute to broader risk stratification frameworks but should be viewed as complementary to genomic testing.
    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
    |
    Oncotype DX Breast Recurrence Score®Test
    7d
    Leflunomide in Previously Treated Metastatic Triple Negative Cancers (clinicaltrials.gov)
    P1/2, N=17, Completed, Joseph Sparano | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    ER positive • HER-2 negative • PIK3CA mutation • HER-2 negative + ER positive
    |
    leflunomide
    8d
    A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    ER positive • HER-2 negative • PIK3CA mutation • HER-2 negative + ER positive
    |
    Kisqali (ribociclib) • letrozole • Itovebi (inavolisib)
    8d
    The impact of neoadjuvant chemotherapy on immunohistochemistry and molecular subtype in breast cancer: A retrospective analysis from Oman. (PubMed, Qatar Med J)
    These changes resulted in adjuvant treatment adjustments in 9/110 (8.18%) patients with residual disease. Changes in the expression of all immunohistochemistry biomarkers and BC subtypes occurred after NACT, which led to changes in adjuvant treatment in specific cases.
    Retrospective data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 overexpression • HER-2 negative • HER-2 negative + ER positive
    9d
    NoLEEta: Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib (clinicaltrials.gov)
    P3, N=3902, Recruiting, UNICANCER | Not yet recruiting --> Recruiting
    Enrollment open • Head-to-Head
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    Kisqali (ribociclib)
    12d
    Study of 68Ga-R10602 (clinicaltrials.gov)
    P1, N=36, Recruiting, Radionetics Oncology | Trial completion date: Mar 2026 --> Jul 2026 | Trial primary completion date: Mar 2026 --> Jul 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    13d
    MIMIR-mTNBC: Molecular PD-L1 PET/CT Imaging With 89Zr-atezolizumab in Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P=N/A, N=3, Terminated, Karolinska University Hospital | N=64 --> 3 | Trial completion date: Mar 2025 --> Mar 2026 | Recruiting --> Terminated; Slow patient accrual; decreasing use of IMP.
    Enrollment change • Trial completion date • Trial termination • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • HER-2 expression • HER-2 negative + ER positive
    |
    Tecentriq (atezolizumab) • carboplatin • albumin-bound paclitaxel
    13d
    Clinical response and prognosis of estrogen receptor-positive and human epidermal growth factor receptor-negative breast cancer patients after neoadjuvant chemotherapy: a retrospective cohort study. (PubMed, Ann Surg Treat Res)
    In ER-positive, HER2-negative breast cancer, clinical responses and post-NAC Ki-67 were significant prognostic factors in patients aged ≤50 years but not in older patients. These findings highlight the need for tailored therapeutic approaches that consider age-specific prognostic differences.
    Retrospective data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • EGFR positive • EGFR negative • HER-2 negative + ER positive
    13d
    Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment (clinicaltrials.gov)
    P3, N=258, Recruiting, Fujian Cancer Hospital
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • HR positive + HER-2 negative • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    capecitabine • AiRuiKang (dalpiciclib)
    15d
    LESS: Deescalation of Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk (clinicaltrials.gov)
    P2, N=696, Active, not recruiting, UNICANCER | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • HER-2 negative + ER positive
    |
    MammaPrint®
    15d
    WSG-AM16: Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing adjuvant Elacestrant with standard endocrine treatment in genomically and/or clinically high-risk ER+/HER2- early breast cancer (ADAPTela) (2025-522484-15-00)
    P2/3, N=1050, Not yet recruiting, WSG Westdeutsche Studiengruppe GmbH
    New P2/3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • HER-2 negative + ER positive
    |
    Kisqali (ribociclib) • Orserdu (elacestrant)