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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
    21h
    Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) (clinicaltrials.gov)
    P3, N=315, Active, not recruiting, AstraZeneca | Trial completion date: Nov 2027 --> Sep 2028
    Trial completion date • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HR positive • HER-2 negative • ESR1 mutation • HR positive + HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation • HER-2 negative + HR positive + ESR1 mutation
    |
    Guardant360® CDx
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • letrozole • anastrozole • camizestrant (AZD9833)
    1d
    Independent, External, Blinded Retrospective Validation of an AI-based Prognostic Assay in ER-Positive/HER2-Negative Early Breast Cancer (clinicaltrials.gov)
    P=N/A, N=2200, Active, not recruiting, Spotlight Medical
    New trial
    |
    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
    FACT-TN: FMD and Neoadjuvant Chemo-immunotherapy in TNBC (clinicaltrials.gov)
    P2, N=80, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • HER-2 negative + ER positive • HER-2 negative + HR negative
    |
    docetaxel • Loqtorzi (toripalimab-tpzi) • doxorubicin hydrochloride • albumin-bound paclitaxel • cyclophosphamide • epirubicin
    1d
    ADAPTela: Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC (clinicaltrials.gov)
    P3, N=1520, Not yet recruiting, West German Study Group | N=1050 --> 1520
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    ER positive • HR positive • HER-2 negative • HER-2 negative + ER positive
    |
    MammaPrint® • Oncotype DX Breast Recurrence Score®Test
    |
    Kisqali (ribociclib) • Orserdu (elacestrant)
    1d
    Level of estrogen receptor expression, histological grade, and computationally assessed stromal TILs on pre-treatment biopsies predict pathological complete response to neoadjuvant chemotherapy in ER-positive/HER2-negative breast cancer. (PubMed, Virchows Arch)
    Response to NACT is strongly influenced by ER expression, tumor grade, and sTIL levels. Composite profiles combining these factors can help identify patients most likely to achieve meaningful response, while also highlighting subgroups with low benefit where alternative treatment strategies may be more appropriate.
    Journal • IO biomarker
    |
    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
    Feasibility and safety of repeat breast-conserving surgery with intraoperative irradiation for local breast carcinoma recurrences: A phase 2 trial. (PubMed, Radiother Oncol)
    Intraoperative reirradiation as part of a second BCS (one-day treatment) is feasible, safe, and well-tolerated in selected patients with late local breast cancer recurrence (i.e. < 2 cm. estrogen receptor-positive and node-negative). These findings suggests that shared decision-making between 'one-day treatment' and salvage mastectomy is a safe and viable option.
    P2 data • Journal
    |
    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
    2d
    Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive/HER2-Negative Advanced Breast Cancer With Brain Metastases (clinicaltrials.gov)
    P2, N=46, Not yet recruiting, Nanfang Hospital, Southern Medical University
    New P2 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 + AR positive + ER positive • HER-2 negative + ER positive
    |
    AiRuiKang (dalpiciclib)
    4d
    Transcriptomic insights into lobular breast cancer biology and patient outcomes: analysis of the MINDACT clinical trial. (PubMed, Clin Cancer Res)
    This represents the largest transcriptomic dataset for ILC from a clinical trial with central histology review. Findings may provide insights to refine treatment and relapse risk assessment for ILC patients.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • CDH1 (Cadherin 1) • CD36 (thrombospondin receptor) • FASN (Fatty acid synthase)
    |
    HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    6d
    Invasive ductal and lobular carcinoma and receptor status in the genetic context of breast cancer. (PubMed, Sci Rep)
    and be estrogen receptor positive [p < 0.001] progesterone status positive [p < 0.001] and HER2 negative [p = 0.043]...This can help clinicians adapt when counseling these patients. Furthermore, ILC keeps its distinctive characteristics independent of the genetic backdrop.
    Journal • BRCA Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • BRCA2 (Breast cancer 2, early onset) • PALB2 (Partner and localizer of BRCA2) • PMS2 (PMS1 protein homolog 2) • CDH1 (Cadherin 1) • CHEK2 (Checkpoint kinase 2) • EPCAM (Epithelial cell adhesion molecule)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    8d
    FAIM: Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression (clinicaltrials.gov)
    P2, N=57, Active, not recruiting, Royal Marsden NHS Foundation Trust | Recruiting --> Active, not recruiting | N=324 --> 57 | Trial completion date: Sep 2026 --> Jun 2027 | Trial primary completion date: Sep 2026 --> Jun 2027
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Circulating tumor DNA
    |
    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
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • ipatasertib (RG7440) • Pegasys (pegylated interferon α -2a)
    9d
    Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=86, Recruiting, Nagoya City University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    Kisqali (ribociclib) • anastrozole
    9d
    A Study on the Use of Fluzoparib Combined With Chemotherapy for Neoadjuvant Treatment of HRD-positive, HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=28, Completed, Xijing Hospital | Recruiting --> Completed | Trial completion date: Dec 2026 --> Mar 2026 | Trial primary completion date: Nov 2026 --> Feb 2026
    Trial completion • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    BRCA2 mutation • ER positive • BRCA1 mutation • HER-2 negative • HRD • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    docetaxel • cyclophosphamide • AiRuiYi (fluzoparib)