Circulating microRNAs and Response to Neoadjuvant Chemotherapy in Breast Cancer

NCT07289282 | Recruiting

• 1 other identifier: Breast-miRNA
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study aims to investigate subtype-specific circulating microRNAs (miRNAs) and their association with response to neoadjuvant chemotherapy (NAC) in patients with breast cancer. Serum samples will be collected before NAC and prior to surgery, and changes in miRNA expression levels will be evaluated. Pathological complete response (pCR) and Miller-Payne scoring will be used to assess treatment response after NAC. The study also explores whether changes in circulating miRNA profiles can predict treatment response across different breast cancer subtypes. The findings may help identify biomarkers that support treatment planning and personalized therapy strategies.

Conditions

Breast Cancer; Neoadjuvant Therapy; Pathological Response; Invasive Breast Carcinoma; MicroRNAs

Keywords

microRNA; Circulating microRNAs; Neoadjuvant Chemotherapy; Pathological Complete Response; Predictive Biomarkers

Outcome Measures

Primary Outcomes (1)

• Change in circulating microRNA expression levels before and after neoadjuvant chemotherapy

  Quantitative assessment of selected serum microRNAs (miR-200a/b/c, miR-34a, miR-221/222, miR-155, miR-146a) using RT-PCR. Changes in expression levels will be compared between baseline and pre-surgery samples.

  Baseline (before NAC) and pre-surgery (after completion of NAC)

Study Arms (1)

Breast Cancer Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients diagnosed with breast cancer who are scheduled to undergo standard neoadjuvant chemotherapy at a single tertiary care center.

You may qualify if:

• Histologically confirmed breast cancer
• Planned to receive neoadjuvant chemotherapy
• Biologically female
• Age ≥ 18 years
• Ability to provide informed consent
• Adequate organ function to receive standard NAC (based on routine clinical evaluation)

You may not qualify if:

• Presence of metastatic disease at diagnosis
• Prior systemic chemotherapy for breast cancer
• Pregnancy or breastfeeding
• Active infection or uncontrolled comorbid conditions interfering with study participation
• Any condition preventing collection of blood samples

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Istanbul Atlas University Faculty of Medicine

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Emine Yildirim, MD

  Atlas University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine 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, MD

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)