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Cancer Cells and Metastasis / HER2/EGFR in Cancer Research · Journal article
International Journal of Molecular Sciences · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This systematic review identified 39 miRNAs potentially associated with pathological complete response in HER2+ breast cancer following neoadjuvant therapy, but substantial heterogeneity, limited replication (only miR-210 confirmed in >1 study), and lack of standardized methodologies preclude clinical implementation. MiR-210 showed consistent association with residual disease in both circulating and tumour-derived compartments, but prospective multicentre validation is required.
Systematic review of observational and experimental studies. HER2+ breast cancer patients undergoing neoadjuvant systemic therapy with chemotherapy and HER2-targeted agents; studies included in the systematic review had varying eligibility criteria and designs. Intervention: miRNA expression profiling (circulating or tumour-derived). Compared with: Pathological complete response versus residual disease / non-pCR status. n = 937.
Nine studies involving 937 HER2+ breast cancer patients identified 39 unique miRNAs associated with pCR outcomes Six circulating miRNAs, four circulating signatures, and seventeen tumour-derived miRNAs showed increased expression associated with pCR Eleven circulating miRNAs and five tumour-derived miRNAs showed increased expression associated with residual disease and non-pCR
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MiRNA profiling is not yet clinically applicable for treatment response prediction in HER2+ breast cancer due to heterogeneity and lack of validation. Clinicians should not use these biomarkers for treatment decisions until prospective multicentre studies establish standardized methodologies and confirm reproducibility.
A systematic review of nine small, heterogeneous studies identifying 39 unique miRNAs with inconsistent associations; substantial heterogeneity and lack of external validation prevent clinical implementation.
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MiRNA profiling is not yet clinically applicable for treatment response prediction in HER2+ breast cancer due to heterogeneity and lack of validation. Clinicians should not use these biomarkers for treatment decisions until prospective multicentre studies establish standardized methodologies and confirm reproducibility.
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MicroRNAs (miRNAs) have emerged as promising biomarkers for treatment response prediction in breast cancer. However, the role of circulating and tumour-derived miRNAs in predicting pathological complete response (pCR) following neoadjuvant therapy in HER2-positive (HER2+) breast cancer remains incompletely defined. To systematically evaluate the association between miRNA expression profiles and pCR in HER2+ breast cancer undergoing neoadjuvant systemic therapy, including chemotherapy with HER2-targeted agents. A systematic review of PUBMED, EMBASE, SCOPUS, and WEB OF SCIENCE databases was performed according to PRISMA guidelines. Studies evaluating circulating or tumour-derived miRNAs associated with pCR following neoadjuvant therapy in HER2+ breast cancer were included. Methodological quality was assessed using the QUIPS tool. Nine studies involving 937 HER2+ breast cancer patients were included. Overall, 39 unique miRNAs and four circulating miRNA signatures were associated with pCR outcomes. Seven studies evaluated circulating miRNAs, while two assessed tumour-derived miRNAs. The increased expression of six circulating miRNAs, four circulating signatures, and seventeen tumour-derived miRNAs was associated with pCR. Conversely, the increased expression of eleven circulating miRNAs and five tumour-derived miRNAs was associated with residual disease and non-pCR. MiR-210 was the only miRNA associated with response across more than one study, with an increased expression associated with residual disease in both circulating and tumour-derived analyses. Several circulating and tumour-derived miRNAs demonstrate potential as predictive biomarkers of pCR following HER2-targeted neoadjuvant therapy. However, substantial heterogeneity and limited validation currently restrict clinical implementation. Future prospective multicentre studies using standardised methodologies are required to clarify the role of miRNA profiling in personalised treatment strategies for HER2+ breast cancer.
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