Tissue- and Serum-Derived Exosomal microRNAs as Predictors of Neoadjuvant Chemotherapy Response in Breast Cancer

NCT07500129 | Not Yet Recruiting

• 1 other identifier: BreastExoTSS-microRNA
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Breast Cancer; Invasive Breast Carcinoma; Exosomal microRNA; Neoadjuvant Chemotherapy Response; Pathological Complete Response

Keywords

Breast Cancer; Breast Cancer Biomarkers; Exosomal microRNA; Circulating microRNA; Tissue-derived exosomes; Serum-derived exosomes; Pathological Complete Response

Outcome Measures

Primary Outcomes (1)

• 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.

  At time of surgery, after completion of neoadjuvant chemotherapy (approximately 4-8 months after baseline)

Secondary Outcomes (1)

• Baseline exosomal microRNA expression levels in breast tissue and serum

  Baseline

Other Outcomes (1)

• Differences in exosomal microRNA expression between malignant and benign breast disease

  Baseline

Study Arms (2)

Breast Cancer + NAC Cohort

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.

Benign Breast Disease Control Cohort

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlas University: lead

Related Links

• Institutional website of Atlas University, the sponsor and coordinating center of this study

Biospecimen

Retention: SAMPLES WITHOUT DNA

Residual serum samples obtained from routine clinical blood tests and leftover tumor tissue collected for diagnostic or surgical purposes as part of standard clinical care. No additional biospecimens will be collected for research purposes.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• EMİNE YILDIRIM

  Atlas University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

EMİNE YILDIRIM, MD

CONTACT

+905056234825; opdreyildirim@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery, MD

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 30, 2026
• Study Start: April 12, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): April 22, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03