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BIOMARKER:

HER-2 positive + HER-2 overexpression

i
Other names: ERBB2, CD340, HER-2, HER2, NEU, NGL, V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2
Entrez ID:
Associations
5d
HER-2 gene alterations as biomarker in patients with metastatic colorectal cancer treated with FOLFIRI + cetuximab: findings from the CAPRI-2 GOIM study. (PubMed, ESMO Gastrointest Oncol)
Of note, 6/7 cases with HER-2 mutations exhibited limited benefit from treatment with FOLFIRI plus cetuximab with PFS inferior to 8 months. Taken together, these results highlight the need to test HER-2 gene alterations for patients with RAS/BRAF V600 WT, MSS mCRC, who are candidates for anti-epidermal growth factor receptor therapies.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene)
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HER-2 positive • HER-2 overexpression • BRAF mutation • HER-2 amplification • HER-2 negative • BRAF V600 • HER-2 mutation • BRAF wild-type • HER-2 positive + HER-2 overexpression
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FoundationOne® CDx
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Erbitux (cetuximab) • 5-fluorouracil • irinotecan • leucovorin calcium
5d
Robust CD8+ T cell responses induced by an mRNA-LNP vaccine encoding rat HER2 extracellular domain confer prophylactic tumor protection. (PubMed, Front Immunol)
The rHER2 ECD mRNA-LNP effectively circumvents HER2-specific immune tolerance. As a potent and safe platform, it induces robust coordinated humoral and cellular immunity and significantly enhances checkpoint blockade efficacy via the enrichment of TRM cells in the TME, which underscores its promising potential for the treatment of HER2-positive cancers.
Preclinical • Journal • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule)
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HER-2 positive • HER-2 overexpression • HER-2 positive + HER-2 overexpression
10d
Radiomics and deep learning fusion model based on multiphasic CT for predicting HER2 expression status in bladder urothelial carcinoma: a multicenter study. (PubMed, Transl Androl Urol)
Human epidermal growth factor receptor 2 (HER2) overexpression is a key therapeutic target for novel antibody-drug conjugates (ADCs) like disitamab vedotin (RC48) in bladder urothelial carcinoma (BLCA), but immunohistochemistry-based assessment is limited by intratumoral heterogeneity and sampling bias...The multimodal model significantly outperformed all single-modality models. A tri-phasic CT-based multimodal model enables noninvasive assessment of HER2 expression status in BLCA, providing a promising tool for selection of patients likely to benefit from ADC therapy.
Clinical • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 overexpression • HER-2 expression • HER-2 positive + HER-2 overexpression
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Aidixi (disitamab vedotin)
12d
Development and Preclinical Evaluation of a Novel 68Ga/177Lu-Labeled Nanobody for Radiotheranostics of HER2-Positive Tumors. (PubMed, J Med Chem)
The kidneys were the primary dose-limiting organ. [68Ga]Ga/[177Lu]Lu-NOTA-NB46 represents a promising radiotheranostic pair for HER2-positive tumors, supporting its further translation into clinical investigation.
Preclinical • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 overexpression • HER-2 positive + HER-2 overexpression
21d
Visceral crisis in HER2-positive, AFP-producing gastric cancer. (PubMed, BMJ Case Rep)
Our patient presented with a visceral crisis denoted by impending liver failure, prompting the urgent initiation of first-line systemic therapy with fluorouracil, leucovorin, oxaliplatin and trastuzumab. This resulted in rapid clinical improvement, normalisation of liver function tests and tumour markers, and radiographic response with approximately 50% reduction in hepatic metastatic disease burden. This case underscores the aggressive behaviour and rarity of HER2-positive, AFP-producing gastric cancer, highlighting the critical need for prompt diagnosis and initiation of systemic therapy.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • AFP (Alpha-fetoprotein)
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HER-2 positive • HER-2 overexpression • HER-2 positive + HER-2 overexpression
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Herceptin (trastuzumab) • 5-fluorouracil • oxaliplatin • leucovorin calcium
26d
Real-World Outcomes of Neoadjuvant Dual Blockade in HER2-Positive Breast Cancer: The Role of Tumor Biology and pCR. (PubMed, J Clin Med)
This multicenter retrospective study included 290 female patients diagnosed with HER2-positive early or locally advanced breast cancer treated with neoadjuvant trastuzumab and pertuzumab-based regimens (anthracycline-based [AC-THP] or non-anthracycline [TCHP]) across six centers. pCR remains the strongest surrogate for survival, neutralizing initial risk factors. These findings support using quantitative biomarker thresholds for personalization and reinforce the efficacy of non-anthracycline regimens.
Clinical • Journal • Real-world evidence
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 overexpression • HER-2 overexpression + HR positive • HER-2 positive + HER-2 overexpression
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Herceptin (trastuzumab) • Perjeta (pertuzumab)
29d
Journal • First-in-human
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 overexpression • HER-2 positive + HER-2 overexpression
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Ziihera (zanidatamab-hrii) • evorpacept (ALX148)
1m
DF1001-001: Study of DF1001 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=270, Completed, Dragonfly Therapeutics | Recruiting --> Completed | Trial completion date: Dec 2026 --> Dec 2025 | Trial primary completion date: Oct 2026 --> Dec 2025
Trial completion • Trial completion date • Trial primary completion date • First-in-human
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 overexpression • HER-2 negative • HER-2 mutation • HER-2 positive + HER-2 overexpression
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HercepTest
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Opdivo (nivolumab) • albumin-bound paclitaxel • Trodelvy (sacituzumab govitecan-hziy) • DF1001
1m
Conversion surgery following trastuzumab and docetaxel combination therapy for unresectable HER2-positive parotid gland cancer. (PubMed, Auris Nasus Larynx)
These cases suggest that systemic HER2-targeted therapy can serve as an effective neoadjuvant approach for locally advanced HER2-positive SGCs. Conversion surgery following Tmab and DTX treatment may offer a curative option in selected patients initially deemed inoperable.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 overexpression • HER-2 positive + HER-2 overexpression
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Herceptin (trastuzumab) • docetaxel
1m
Enrollment change
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon) • POLD1 (DNA Polymerase Delta 1)
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HER-2 positive • MSI-H/dMMR • KRAS G12C • HER-2 amplification • HER-2 mutation • MET amplification • POLE mutation • KRAS wild-type • RAS wild-type • KRAS G12 • POLD1 mutation • HER-2 positive + HER-2 overexpression • HER-2 positive + RAS wild-type
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Opdivo (nivolumab) • Imfinzi (durvalumab) • Vectibix (panitumumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Lumakras (sotorasib) • balstilimab (AGEN2034) • botensilimab (AGEN1181) • vorbipiprant (CR6086)
2ms
A Study of Tucatinib and Trastuzumab in People With Rectal Cancer (clinicaltrials.gov)
P2, N=37, Recruiting, Memorial Sloan Kettering Cancer Center | Trial primary completion date: Jun 2026 --> Jul 2027
Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase)
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HER-2 positive • HER-2 overexpression • HER-2 amplification • RAS wild-type • HER-2 positive + HER-2 overexpression • HER-2 positive + RAS wild-type
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Herceptin (trastuzumab) • Tukysa (tucatinib)
2ms
Exceptional and Durable Complete Response to Ado-Trastuzumab Emtansine in HER2-Positive Metastatic Breast Cancer: A Case Report. (PubMed, Cureus)
She received first-line chemotherapy with trastuzumab, pertuzumab, and docetaxel, followed by maintenance anti-HER2 therapy and surgery for local disease control. This case may represent an exceptional response to T-DM1 and highlights the potential for durable complete remission in selected patients with HER2-positive metastatic breast cancer. Further investigation is warranted to identify predictive factors for exceptional responses and to determine optimal treatment duration.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 overexpression • EGFR positive • HER-2 positive + HER-2 overexpression
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docetaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine)