This prospective observational study aims to evaluate whether exosomal microRNA profiles derived from tumor tissue and blood serum are associated with pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) in patients with breast cancer.
Breast cancer patients with similar clinical and pathological features may respond differently to treatment, underscoring the need for reliable biomarkers that can help predict therapeutic outcomes. Exosomes are small extracellular vesicles released by tumor cells that carry molecular signals, including microRNAs, which may reflect tumor behavior and treatment sensitivity.
In this study, patients with breast cancer receiving standard NAC as part of routine clinical care will be followed prospectively. Exosomal microRNA profiles obtained from tumor tissue and blood samples collected during routine diagnostic and treatment procedures will be analyzed and compared with pathological complete response (pCR) assessed after completion of neoadjuvant chemotherapy.
A group of patients with benign breast disease will be included as a reference control for comparative analyses.
The results of this study may contribute to the identification of minimally invasive biomarkers that support personalized treatment strategies in breast cancer.
Female patients aged 18 years or older
Histologically confirmed locally advanced breast cancer scheduled to receive neoadjuvant chemotherapy
Availability of residual tumor tissue and/or serum samples obtained during routine clinical care
Ability to provide written informed consent
Male sex
Age under 18 years
Prior systemic chemotherapy or radiotherapy administered for the current breast disease before enrollment.
Evidence of metastatic disease at diagnosis (for breast cancer cohort)
Female patients aged 18 years or older will be enrolled into two cohorts: 1. patients with histologically confirmed breast cancer who are scheduled to receive neoadjuvant chemotherapy, and 2. patients with histologically confirmed benign breast disease. Participants will be recruited from multiple clinical centers. Only leftover tumor tissue and serum samples obtained during routine diagnostic or therapeutic procedures will be used for exosomal microRNA analysis.
Cohort
Prospective
Not listed
Pathological complete response (pCR) rate after neoadjuvant chemotherapy
The primary outcome is pathological complete response (pCR), defined as the absence of residual invasive cancer in the breast and axillary lymph nodes (ypT0/is, ypN0), assessed using standard pathological evaluation after completion of neoadjuvant chemotherapy.
Baseline exosomal microRNA expression levels in breast tissue and serum
Exosomal microRNA expression levels will be measured in tumor tissue and serum samples collected at baseline using standardized molecular analysis methods (e.g., qRT-PCR or RNA sequencing). Expression levels will be quantitatively analyzed and compared across pathological response categories (pathological complete response, partial response, and no response).
Differences in exosomal microRNA expression between malignant and benign breast disease
Exploratory analyses will be conducted to identify tissue- and serum-derived exosomal microRNAs with potential predictive value for response to neoadjuvant chemotherapy in breast cancer. Differential expression analysis will be performed to identify candidate microRNA signatures associated with malignancy.
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