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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
    1d
    PROMISE: Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy (clinicaltrials.gov)
    P=N/A, N=68, Active, not recruiting, Mayo Clinic | Trial completion date: Mar 2026 --> Mar 2028 | Trial primary completion date: Mar 2026 --> Mar 2028
    Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Ibrance (palbociclib)
    2d
    Testing Low Dose Tamoxifen for Invasive Breast Cancer, LoTam Trial (clinicaltrials.gov)
    P3, N=1556, Suspended, Alliance for Clinical Trials in Oncology | N=1156 --> 1556
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Prosigna® Breast Risk of Recurrence (ROR) Test • Oncotype DX Breast Recurrence Score®Test
    |
    tamoxifen • letrozole • anastrozole • exemestane
    3d
    Evaluating the investigational drug landscape for ESR1-mutated, estrogen receptor positive, HER2 negative metastatic breast cancer. (PubMed, Expert Opin Investig Drugs)
    Routine assessment of ESR1 mutations using liquid biopsy should be integrated into clinical practice to enable dynamic, molecularly guided treatment optimization. The expanding arsenal of ER-targeted therapies supports personalized sequencing strategies that move beyond rigid temporal cutoffs and improve outcomes in ET resistant disease.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ESR1 mutation • ER positive + HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    3d
    CAAA603B12101: [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=48, Recruiting, Novartis Pharmaceuticals | Active, not recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Kisqali (ribociclib) • fulvestrant • goserelin acetate • AAA603
    5d
    ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer (clinicaltrials.gov)
    P1, N=46, Completed, Ono Pharmaceutical Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • letrozole • BMS-986310
    5d
    Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial (clinicaltrials.gov)
    P3, N=1978, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Jul 2026 --> Feb 2027
    Enrollment open • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ER negative • HER-2 negative + ER positive
    |
    Oncotype DX Breast Recurrence Score®Test
    |
    Kisqali (ribociclib) • letrozole • anastrozole • exemestane
    5d
    Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jun 2026 --> Dec 2026 | Trial primary completion date: Jun 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • fulvestrant
    5d
    Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial) (clinicaltrials.gov)
    P=N/A, N=400, Not yet recruiting, IceCure Medical Ltd.
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    6d
    Pre-analytical variables affecting breast cancer biomarker expression: A controlled single-specimen study of fixation duration, cold ischemia time, and fixative preparation in a low-resource setting. (PubMed, PLoS One)
    In this single-specimen controlled experiment, non-buffered formaldehyde preserved tissue biomarkers with small but measurable differences relative to neutral buffered formaldehyde for IHC analysis, although these findings require validation in multi-patient studies. Consistent with current guidelines, a cold ischemia time of up to 1 hour maintained adequate biomarker preservation. These preliminary results may be relevant for pathology laboratories in resource-limited settings where neutral buffered formalin may not be easily accessible, and warrant further investigation across diverse tumor types and baseline expression levels, particularly tumors with ER-low-positive (1-10%) or heterogeneous expression.
    Journal
    |
    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 + ER positive
    6d
    CAAA603B12101: [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=48, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Kisqali (ribociclib) • fulvestrant • goserelin acetate • AAA603
    7d
    Methylation-based ctDNA monitoring in metastatic breast cancer during CDK4/6 inhibitor therapy. (PubMed, Nat Commun)
    A rise in mTF (molecular progression) precedes treatment discontinuation by a median of 5.8 months and outperforms mutation-based tracking, with resistance-associated alterations in ESR1 and RB1 frequently emerging at molecular progression. These findings support prospective evaluation of mTF-guided treatment strategies.
    Journal • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • RB1 (RB Transcriptional Corepressor 1)
    |
    ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    7d
    KEYNOTE-242: Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer (clinicaltrials.gov)
    P3, N=1155, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: May 2027 --> Aug 2026 | Trial primary completion date: May 2027 --> Aug 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)
    |
    PD-L1 expression • HER-2 positive • ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    Keytruda (pembrolizumab)