Clinical trial · Observational
Tissue- and Serum-Derived Exosomal microRNAs as Predictors of Neoadjuvant Chemotherapy Response in Breast Cancer
Clinical and Mechanistic Validation of a Tumor-Derived Extracellular Vesicle-Associated miRNA Signature Predicting Response to Neoadjuvant Chemotherapy in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Exosomal microRNA | — | UNRESOLVED | — |
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neoadjuvant Chemotherapy Response | — | UNRESOLVED | — |
| Pathological Complete Response | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Breast Cancer + NAC Cohort
- description
- Patients with histologically confirmed locally advanced breast cancer who are scheduled to receive standard-of-care neoadjuvant chemotherapy. No additional tissue or blood samples will be collected for research purposes; only residual tumor tissue and serum obtained during routine clinical care will be used for exosomal microRNA analysis. Molecular findings will be correlated with pathological complete response (pCR) after treatment.
- label
- Benign Breast Disease Control Cohort
- description
- Patients with histologically confirmed benign breast lesions. No additional tissue or blood samples will be collected for research purposes; only residual tissue and serum obtained during routine diagnostic or therapeutic procedures will be used for exosomal microRNA profiling to serve as a non-malignant control group.
Primary outcomes (1)
- measure
- Pathological complete response (pCR) rate after neoadjuvant chemotherapy
- timeFrame
- At time of surgery, after completion of neoadjuvant chemotherapy (approximately 4-8 months after baseline)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Pregnancy or breastfeeding * Any condition that precludes the availability or adequate quality of tissue or blood samples for research purposes
References
Publications (0)
Data not yet available