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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:
    22h
    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
    A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer (clinicaltrials.gov)
    P=N/A, N=100, Not yet recruiting, xuliang
    New trial • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    Itovebi (inavolisib)
    1d
    AMBITION: A Phase III Study of Bevacizumab and Paclitaxel in Combination With Atezolizumab as a Treatment for Locally Advanced Unresectable or Metastatic Hormone Receptor-positive HER2 Negative Breast Cancer (clinicaltrials.gov)
    P3, N=281, Completed, Japanese Foundation for Cancer Research | Trial completion date: Sep 2025 --> Mar 2026 | Active, not recruiting --> Completed
    Trial completion • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HR positive • HER-2 negative
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • paclitaxel
    1d
    A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer) (clinicaltrials.gov)
    P3, N=300, Not yet recruiting, Genentech, Inc.
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    giredestrant (RG6171)
    1d
    Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca (clinicaltrials.gov)
    P2, N=46, Active, not recruiting, Virginia Commonwealth University | Trial completion date: Mar 2026 --> Mar 2027
    Trial completion date • Checkpoint inhibition • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative • HR negative • HER-2 negative + HR negative
    |
    Keytruda (pembrolizumab) • carboplatin • doxorubicin hydrochloride • albumin-bound paclitaxel • cyclophosphamide • decitabine
    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
    Atezolizumab + Stereotactic Radiation in Triple-negative Breast Cancer and Brain Metastasis (clinicaltrials.gov)
    P2, N=6, Completed, Dana-Farber Cancer Institute | Active, not recruiting --> Completed | Trial completion date: Apr 2026 --> Nov 2025
    Trial completion • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Tecentriq (atezolizumab)
    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
    A Rare Case of Palbociclib-Induced Pancolitis: Clinical Insights and Literature Review. (PubMed, Cureus)
    While generally well tolerated, their toxicity profiles differ, with palbociclib and ribociclib more commonly associated with hematologic toxicity and abemaciclib with gastrointestinal adverse effects such as diarrhea...We report a 65-year-old woman with metastatic HR+ breast cancer who presented with a two-week history of watery diarrhea (10-12 episodes/day), abdominal cramping, and a 5-pound weight loss while receiving palbociclib, fulvestrant, and denosumab...Although biopsy later demonstrated cytomegalovirus (CMV) positivity, antiviral therapy was deferred given negative CMV PCR and complete clinical resolution. This case highlights an uncommon presentation of palbociclib-induced pancolitis and underscores the importance of careful clinical evaluation and contextual interpretation of histologic findings to avoid unnecessary treatment.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • Prolia (denosumab)
    1d
    Pure Mucinous Breast Carcinoma: Integrating Molecular and Immunohistochemical Profiles for Accurate Diagnosis-A Case Report. (PubMed, Case Rep Oncol Med)
    Pure MCB is a rare, low-grade tumor with distinct pathological features. Accurate diagnosis and complete surgical excision are essential for optimal management, as patients typically achieve excellent long-term outcomes.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 negative • HER-2 negative + AR positive + ER positive