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BIOMARKER:

HER-2 positive

i
Other names: ERBB2, CD340, HER-2, HER2, NEU, NGL, V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2
Entrez ID:
21h
Novel CDK2/4/6 inhibitor culmerciclib (TQB3616) plus fulvestrant in previously treated, HR-positive, HER2-negative advanced breast cancer: a randomized, double-blind, phase 3 trial. (PubMed, Signal Transduct Target Ther)
In conclusion, this randomized clinical trial met its primary outcome. Culmerciclib plus fulvestrant is well tolerated and leads to a significant gain in PFS of pretreated HR-positive HER2-negative ABC patients.
Clinical • P3 data • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
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fulvestrant • Setanxin (culmerciclib)
21h
Recent treatment and survival trends in older versus younger women with HR-positive HER2-negative metastatic breast cancer in the real-life multicenter French ESME cohort. (PubMed, Eur J Cancer)
ET+CDK4/6i use rose up to ∼50 % after 2017, reaching ∼70 % in recent years among women with good PS, but remained ∼50 % in older patients with poor PS. Broader adoption is needed, with less chemotherapy use. Survival outcomes have improved but, causality cannot be confirmed due to the observational design.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
1d
Changing Practices in Axillary Surgery After Neoadjuvant Breast Cancer Therapy: Insights From the EUSOMA European Database. (PubMed, J Surg Oncol)
This study evidences a substantial shift towards SLNB as the primary axillary surgery following NAT during the study period. This trend emphasizes a preference for less invasive procedures, likely due to the efficacy of neoadjuvant therapy in reducing axillary lymph node involvement.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
1d
Beyond The Age Limit: A Comparative Study (<70 Vs ≥70 Years) in Breast Cancer Characteristics and Surgical Management in Women. (PubMed, Breast Cancer (Dove Med Press))
These findings demonstrate important differences in disease presentation and surgical management between age groups in Turkey, where breast cancer screening ends at age 69. The absence of screening detection in elderly patients, combined with their advanced disease presentation, highlights the need for further investigation with larger, multicenter cohorts to evaluate optimal screening strategies for women beyond age 69.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 negative
2d
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis (clinicaltrials.gov)
P2, N=16, Recruiting, Wake Forest University Health Sciences | Trial primary completion date: Dec 2025 --> May 2026
Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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HER-2 positive • HER-2 negative • ER negative • HER-2 negative + AR positive + ER positive
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methotrexate IV
3d
Atezolizumab, Cobimetinib, and Eribulin in Treating Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer (clinicaltrials.gov)
P2, N=37, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
Trial completion date • Trial primary completion date
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PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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HER-2 positive
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Tecentriq (atezolizumab) • Cotellic (cobimetinib) • Halaven (eribulin mesylate)
3d
HER2 expression in breast cancer: evidence gaps and challenges. (PubMed, NPJ Precis Oncol)
This evolving landscape challenges the traditional use of HER2 as a diagnostic marker and underscores the need for a deeper understanding of HER2 biology. This review addresses these complexities, focusing on the emerging HER2-Low and Ultralow subtypes, and evaluates the distinct therapeutic responses across the spectrum of HER2 expression in different BC subtypes.
Review • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 negative • HER-2 expression
3d
TQB2440 compared with reference pertuzumab for HER2-positive, ER/PgR-negative, early or locally advanced breast cancer: a multicenter, randomized, double-blind, parallel-controlled, phase III equivalence trial. (PubMed, ESMO Open)
TQB2440 showed equivalent efficacy, comparable safety, PK, and immunogenicity profiles to reference pertuzumab in the neoadjuvant treatment of patients with HER2-positive early or locally advanced breast cancer.
Clinical • P3 data • Journal
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HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
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HER-2 positive • EGFR positive
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Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • Ansaizhu (pertuzumab biosimilar) • Paletan (pertuzumab biosimilar)
3d
Sequencing antibody-drug conjugates in metastatic breast cancer: A systematic review. (PubMed, Cancer Treat Rev)
Emerging evidence indicates that sequential ADC use can be effective despite some cross-resistance, especially when distinct payload mechanisms are employed. Clinical use should consider payload type, timing, and breast cancer subtype, but toxicities remain critical for decision-making. Research providing insights into resistance mechanisms and biomarkers is needed for personalized approaches.
Review • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 negative
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Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki)
4d
Evaluation of the clinical characteristics and potentially prognostic factors in HER2-positive breast cancer. (PubMed, Amino Acids)
Patients with HR+ /HER2+ BC had lower risks of breast cancer-specific death and higher overall survival rates. Mast cells were enriched in the HR+ /HER2+ BC group, while plasma cells were more abundant in the HR-/HER2+ BC group.In conclusion, HER2+ BC patients benefit differently from current HER2-directed therapies, maybe partly due to the HR status and gene mutations, and they may provide potentially prognostic and predictive value and new treatment strategies for clinicians.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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HER-2 positive • HER-2 mutation
4d
HERIZON-GEA-01: A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers (clinicaltrials.gov)
P3, N=920, Active, not recruiting, Jazz Pharmaceuticals | Trial completion date: May 2026 --> Jul 2027 | Trial primary completion date: Dec 2025 --> Jul 2026
Trial completion date • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 expression
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Herceptin (trastuzumab) • cisplatin • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • Ziihera (zanidatamab-hrii)