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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
    20d
    Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Pts w/Low Risk, Hormone Responsive Brst Ca (clinicaltrials.gov)
    P2, N=48, Active, not recruiting, City of Hope Medical Center | Trial completion date: Jun 2026 --> May 2027 | Trial primary completion date: Jun 2026 --> May 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    21d
    The Indication of Adjuvant Therapy Based on Oncotype DX Recurrence Score in Relation to Clinical and Pathological Factors, and Survival: A Retrospective Analysis of Real-World Use. (PubMed, J Nippon Med Sch)
    Real-world data demonstrate that ODRS correlates with key pathological characteristics and can guide adjuvant therapy selection, independent of menopausal status or nodal involvement. This suggests that ODRS is useful in tailoring chemotherapy decisions in ER-positive/HER2-negative breast cancer.
    Retrospective data • Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • ER positive • HER-2 negative • EGFR positive • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    Oncotype DX Breast Recurrence Score®Test
    23d
    A phase 1b study of chemo-immunotherapy with pegylated liposomal doxorubicin and Pembrolizumab in estrogen receptor positive metastatic breast cancer. (PubMed, Cancer Res Commun)
    The combination of PLD with pembrolizumab is well tolerated, active, and feasible for extended treatment with durable responses. The results suggest possible contribution of pembrolizumab to the anti-tumor effect.
    P1 data • Journal • PD(L)-1 Biomarker • 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
    |
    Keytruda (pembrolizumab) • pegylated liposomal doxorubicin
    23d
    Young HOPE: Evaluating the Response-Guided Therapy With Neoadjuvant Endocrine Therapy to Optimize Adjuvant Treatment in Premenopausal HR+/HER2- Breast Cancer (JCOG2402, Youg HOPE) (clinicaltrials.gov)
    P3, N=950, Recruiting, Tokyo Women's Medical University
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • HER-2 negative + ER positive
    |
    Oncotype DX Breast Recurrence Score®Test
    |
    tamoxifen
    24d
    ASTEROID: A Trial of ASTX660 in Combination With Pembrolizumab (clinicaltrials.gov)
    P1, N=61, Active, not recruiting, Institute of Cancer Research, United Kingdom | Recruiting --> Active, not recruiting | Trial completion date: Mar 2026 --> Dec 2026 | Trial primary completion date: Mar 2026 --> Dec 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TERT (Telomerase Reverse Transcriptase)
    |
    HER-2 positive • ER positive • HER-2 negative • EGFR amplification • IDH wild-type • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    Keytruda (pembrolizumab) • tolinapant (ASTX660)
    24d
    Neoadjuvant stereotactic body radiation therapy with durvalumab and oleclumab in ER+HER2- breast cancer: a randomized phase 2 trial. (PubMed, Nat Med)
    These findings suggest that iSBRT + anti-PD-L1 may convert immune-cold ER+HER2- BC into more inflamed tumors and improve response, particularly in PD-L1-negative disease. ClinicalTrials.gov registration: NCT03875573 .
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    PD-L1 expression • ER positive • HER-2 negative • PD-L1 negative • HER-2 negative + ER positive
    |
    MammaPrint®
    |
    Imfinzi (durvalumab) • oleclumab (MEDI9447)
    24d
    Circulating Tumor DNA Based Minimal Residual Disease Detection for Patients With Early-Stage Breast Cancer (clinicaltrials.gov)
    P=N/A, N=0, Withdrawn, City of Hope Medical Center | N=350 --> 0 | Trial completion date: Mar 2028 --> Jun 2026 | Suspended --> Withdrawn | Trial primary completion date: Mar 2028 --> Jun 2026
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Minimal residual disease • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    25d
    CAAA603B12101: [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=48 --> 22
    Enrollment closed • Enrollment change
    |
    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
    25d
    CAAA603D12101: A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor. (clinicaltrials.gov)
    P1/2, N=20, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=58 --> 20
    Enrollment closed • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HER-2 negative • HER-2 negative + ER positive
    |
    capecitabine • AAA603
    25d
    A Phase II Clinical Study of the Efficacy and Safety of Culmerciclib Rechallenge in HR-positive, HER2-negative Breast Cancer Patients With Resistance to First-line Endocrine Therapy. (clinicaltrials.gov)
    P2, N=98, Recruiting, Fudan University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • HER-2 expression • HER-2 negative + ER positive
    |
    fulvestrant • Saitanxin (culmerciclib)
    26d
    Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=27, Recruiting, Xijing Hospital | Trial primary completion date: Apr 2026 --> Dec 2026
    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
    |
    Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel • cyclophosphamide • epirubicin
    26d
    BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, University of Illinois at Chicago | Trial completion date: May 2026 --> May 2027 | Trial primary completion date: May 2026 --> May 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    MammaPrint® • EndoPredict®
    |
    azacitidine