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TEST:
HER2DX

Type:
Laboratory Developed Test
Related tests:
Evidence

News

4d
Quantitative HER2 tissue and plasma profiling predicts the activity of trastuzumab deruxtecan for breast cancer. (PubMed, NPJ Precis Oncol)
Conversely, HER2 immunohistochemical subtypes showed limited predictive value for clinical outcomes. Additionally, elevated TOPO1 expression was associated with worse outcomes with T-DXd in HER2-negative breast cancer, suggesting potential relevance for payload-related markers in predicting T-DXd performance.
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
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HER2DX
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Enhertu (fam-trastuzumab deruxtecan-nxki)
28d
HCB-ONC002: HER2DX-guided diagnostic treatment For patients with HER2-positive early-stage breast cancer (2025-521040-37-00)
P2/3, N=224, Recruiting, Fundacio De Recerca Clinic Barcelona-Institut DInvestigacions Biomediques August Pi I Sunyer
New P2/3 trial
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HR positive • HR negative
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HER2DX
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carboplatin • paclitaxel • docetaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • albumin-bound paclitaxel • cyclophosphamide • epirubicin • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
1m
Validation of the HER2DX genomic test in first-line advanced HER2-positive breast cancer treated with trastuzumab, pertuzumab, and taxane. (PubMed, NPJ Breast Cancer)
In conclusion, the HER2DX ERBB2 mRNA score provides independent prognostic information in HER2+ advanced breast cancer treated with THP. The HER2DX metastatic prognostic score further improves prognostic accuracy.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
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HER2DX
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Herceptin (trastuzumab) • Perjeta (pertuzumab)
1m
Clinical decision impact of HER2DX, an algorithm-powered genomic diagnostic in early-stage HER2-positive breast cancer: results from a prospective real-world study. (PubMed, ESMO Real World Data Digit Oncol)
Physician confidence improved (P < 0.001) and the estimated total cost savings, including direct drug costs, vein access devices, and HER2DX costs, amounted to €98 031. HER2DX impacts clinical management in stage I-III HER2-positive BC by supporting treatment adjustments, enhancing physician confidence, maintaining pCR rates, and reducing health care costs.
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 expression • EGFR positive
|
HER2DX
1m
Case Report: Personalized management of HER2-positive breast cancer with advanced nodal disease during pregnancy: a clinical case and review. (PubMed, Front Oncol)
The patient subsequently received adjuvant chest wall and nodal region radiotherapy plus trastuzumab-emtansine (T-DM1). This case underscores the value of personalized, multidisciplinary management in PrBC, particularly in patients with high-risk biologic features and advanced nodal disease. Integrating clinical judgment, genomic tools, and adaptive strategies, while accounting for gestational limitations, can optimize oncologic outcomes without compromising fetal safety.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
|
HER2DX
|
Kadcyla (ado-trastuzumab emtansine)
3ms
20th anniversary of adjuvant trastuzumab: reflections on a breakthrough moment. (PubMed, Ann Oncol)
Similarly, while clinical factors and imaging tools may help identify early on patients at higher risk of experiencing TIC, no cardioprotective strategy has yet demonstrated robust and conclusive benefit. Despite the emergence of newer anti-HER2 agents and evolving treatment paradigms, trastuzumab will probably continue to serve as a key therapeutic backbone, especially for patients with lower risk HER2+ eBC.
Review • Journal
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HER-2 overexpression • HER-2 amplification • EGFR positive
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HER2DX
4ms
Associations of the HER2DX Genomic Test with Biological and Pathological Features in HER2-positive Breast Cancer. (PubMed, Clin Cancer Res)
HER2DX reflects key biological and pathological features of HER2+ breast cancer and independently predicts pCR, supporting its utility for individualized treatment decision-making.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 expression
|
HER2DX
|
Herceptin (trastuzumab)
4ms
HER2DX in older patients with HER2-positive early breast cancer: extended follow-up from the RESPECT trial of trastuzumab ± chemotherapy. (PubMed, Nat Commun)
HER2DX offers prognostic value and may guide chemotherapy use in older patients with HER2-positive early breast cancer. Clinical Trial Information NCT01104935.
Clinical • Journal
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HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
HER2DX
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Herceptin (trastuzumab)
6ms
DEFINITIVE: Diagnostic HER2DX-guided Treatment for Patients wIth Early-stage HER2-positive Breast Cancer (clinicaltrials.gov)
P=N/A, N=304, Recruiting, Fundacio Clinic Barcelona | Not yet recruiting --> Recruiting
Enrollment open
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HER2DX
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carboplatin • paclitaxel • docetaxel • Perjeta (pertuzumab)
6ms
HER2DX ERBB2 score in advanced HER2-positive gastric cancer treated with trastuzumab and chemotherapy. (PubMed, ESMO Open)
These results suggest that ERBB2 mRNA expression, as measured by HER2DX, may help refine selection for T-chemo and guide more personalized treatment strategies in HER2-positive AGC.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 expression • EGFR positive
|
HER2DX
|
Herceptin (trastuzumab)
8ms
Meta-Analysis In The Lancet Oncology Validates Her2dx Prognostic Value In Early Her2-Positive Breast Cancer (Reveal Genomics Press Release)
"Reveal Genomics... today announced the publication of the study 'HER2DX and survival outcomes in early-stage HER2-positive breast cancer: an individual patient-level meta-analysis' in The Lancet Oncology.In the most comprehensive analysis to date of the HER2DX genomic test, investigators evaluated its prognostic utility across more than2,500 patients with early-stage HER2-positive (HER2+) breast cancer. Data from 11 international studies, including APT, ATEMPT, CALGB40601, DAPHNe, and PHERGain, were harmonized to assess the ability of HER2DX to stratify long-term risk and inform personalized treatment strategies in both neoadjuvant and adjuvant settings."
Clinical data
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HER2DX
8ms
HER2DX and survival outcomes in early-stage HER2-positive breast cancer: an individual patient-level meta-analysis. (PubMed, Lancet Oncol)
HER2DX provides clinically meaningful prognostic stratification in early-stage HER2-positive breast cancer, beyond standard clinical-pathological variables and pathological response. These results support its use in tailoring treatment intensity and guiding clinical decision making.
Retrospective 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 amplification
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HER2DX