TEST:

HER2DX

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.

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.

HER2DX reflects key biological and pathological features of HER2+ breast cancer and independently predicts pCR, supporting its utility for individualized treatment decision-making.

HER2DX offers prognostic value and may guide chemotherapy use in older patients with HER2-positive early breast cancer. Clinical Trial Information NCT01104935.

P=N/A, N=304, Recruiting, Fundacio Clinic Barcelona | Not yet recruiting --> Recruiting

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.

"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."

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.

In advanced HER2-positive breast cancer, the standard taxane-trastuzumab-pertuzumab (THP) regimen faces competition from new therapies, emphasizing the need for biomarkers to guide treatment. Patients with ERBB2-high scores had significantly better median PFS (33.9 vs. 10.6 months, hazard ratio &lsqb;HR] = 0.40, 95% CI: 0.24-0.69, p < 0.001) and OS (not reached vs. 30.8 months, HR = 0.26, 95% CI: 0.13-0.49, p < 0.001) compared to ERBB2-low patients. Based on these findings, further validation of this biomarker in tumor samples from the CLEOPATRA phase III trial is ongoing, which could help optimize treatment strategies in this population.

HER2DX integrates tumor size and nodal involvement with 27 genes' expression data tracking four biological BC-related and immunologic signatures so to estimate a prognostic and a predictive score. This report demonstrates how clinical and genomic data can be effectively integrated to optimize therapeutic decisions in HER2+ BC, offering a model for personalized care also in atypical and complex cases.

The HER2DX pCR score could predict pCR in stage III HER2-positive IBC following treatment with de-escalated neoadjuvant systemic therapy and in stage III HER2-positive non-IBC. Elevated pCR rates in HER2-positive IBC with high HER2DX pCR scores suggest there may be a role for treatment de-escalation in these patients and confirmatory studies are justified.