^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    BIOMARKER:

    HER-2 negative + HR 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
    Associations

    News

    Trials
    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
    4d
    Combined ypT0 and ycN0 for Risk Stratification of ypN0 in Clinically Node-Positive Breast Cancer After Neoadjuvant Chemotherapy: A Multicenter Cohort Study. (PubMed, Clin Breast Cancer)
    A combination of ypT, ycN, and HR/HER2 status was strongly associated with ypN0 in patients with cN+ breast cancer. These findings represent a bridging study supporting risk stratification and the design of future trials evaluating axillary surgery omission.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 positive • HER-2 negative + HR negative
    10d
    Clinical presentations and prognostication of HER2-low and HER2-zero early breast cancer in Taiwan. (PubMed, J Chin Med Assoc)
    In Taiwanese early stage breast cancer, HER2-low is common and associated with greater HR positivity and modestly inferior OS/RFS relative to HER2 zero after HR and stage stratification. These clinicopathological distinctions may influence future eligibility for the novel targeted therapy at metastatic relapse, even when early stage outcome differences are small. Further studies are warranted to understand the biological and therapeutic relevance of this newly established taxonomy.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HER-2 negative + HR negative
    16d
    TRIFOUR: Nadunolimab in Combination With Gemcitabine Plus Carboplatin in Patients With Advanced Triple Negative Breast Cancer. (clinicaltrials.gov)
    P1/2, N=117, Active, not recruiting, Cantargia AB | Trial primary completion date: Jun 2025 --> Apr 2026
    Trial primary completion date • BRCA Companion diagnostic • PARP Companion diagnostic
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset) • CD4 (CD4 Molecule)
    |
    BRCA2 mutation • BRCA1 mutation • HER-2 negative • HER-2 negative + HR negative • HER-2 negative + HR negative + BRCA mutation
    |
    PD-L1 IHC 22C3 pharmDx • Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    carboplatin • gemcitabine • nadunolimab (CAN04)
    24d
    Add-Aspirin: A Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival After Primary Therapy in Common Non Metastatic Solid Tumours (clinicaltrials.gov)
    P3, N=11000, Active, not recruiting, University College, London | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • ER positive • HR positive • HER-2 negative • HR negative • ER negative • HER-2 negative + ER positive • HER-2 negative + HR negative
    |
    aspirin
    24d
    GIM25-CAPT: A Phase II trial of atezolizumab plus CArboplatin plus nab-Paclitaxel as first-line Therapy in metastatic triple-negative PD-L1 positive breast cancer patients (2024-519514-31-00)
    P1/2, N=104, Recruiting, Consorzio Oncotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 negative • HR negative • HER-2 negative + HR negative
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Tecentriq (atezolizumab) • carboplatin • albumin-bound paclitaxel
    26d
    Prognosis of Pregnancy-Associated Breast Cancer: A Systematic Review of Contemporary Observational Studies. (PubMed, Med Sci (Basel))
    Current evidence suggests that pregnancy itself does not inevitably worsen breast cancer prognosis when treatment is not compromised. However, breast cancers diagnosed soon after childbirth represent a distinct high-risk subgroup. These findings support full-intensity, guideline-based therapy during pregnancy and highlight the need for special attention and further research focused on postpartum breast cancer.
    Observational data • Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative • HR negative • HER-2 negative + HR negative • HR negative + HER-2 positive
    2ms
    A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer Harboring a PIK3CA Mutation (clinicaltrials.gov)
    P2, N=26, Not yet recruiting, Hu Hai
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    HER-2 amplification • HER-2 negative • PIK3CA mutation • HER-2 negative + HR negative
    |
    Halaven (eribulin mesylate) • Itovebi (inavolisib)
    3ms
    FACT-TN: FMD and Neoadjuvant Chemo-immunotherapy in TNBC (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Sun Yat-sen University
    New P2 trial
    |
    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
    3ms
    BNT326-01: A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=980, Recruiting, BioNTech SE | N=550 --> 980 | Trial completion date: Feb 2030 --> Oct 2029 | Trial primary completion date: May 2028 --> Feb 2028
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR mutation • HR positive • BRAF mutation • HER-2 negative • EGFR L858R • HER-2 expression • EGFR exon 19 deletion • ALK rearrangement • PD-L1 expression + HER-2 overexpression • HER-2 negative + HR negative
    |
    itraconazole • pumitamig (BNT327)
    3ms
    Modern Management of the Axilla in HER2-Negative Hormone Receptor-Positive Early Breast Cancer Upfront Surgery: Toward De-Escalation and Individualization. (PubMed, Cancers (Basel))
    In conclusion, modern axillary management in HR-positive, HER2-negative breast cancer involves navigating the intersection between de-escalated surgery and risk-adapted systemic therapy. Future strategies should prioritize individualized care, incorporating tumor biology, imaging findings, and patient preferences, with multidisciplinary collaboration playing a central role in optimizing outcomes.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HER-2 negative + HR negative