Actively Recruiting
The Relationship Between microRNAs in Breast Cancer Subtypes and Response to Neoadjuvant Chemotherapy and Pathological Response
Led by Atlas University · Updated on 2026-03-31
80
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how specific circulating microRNAs (miRNAs) relate to the response to neoadjuvant chemotherapy (NAC) in breast cancer patients. This observational study focuses on changes in miRNA levels before starting NAC and before surgery, aiming to understand their association with treatment outcomes. The study also explores whether these miRNA changes can predict responses across different breast cancer subtypes, potentially helping to guide personalized therapy. Participants diagnosed with breast cancer and scheduled for standard NAC will have serum samples collected at two key points: before starting chemotherapy and after completing NAC but before surgery. The study will use quantitative RT-PCR to measure selected miRNAs such as the miR-200 family, miR-34a, miR-221/222, miR-155, and miR-146a. Treatment response will be assessed using pathological complete response (pCR) status and Miller-Payne tumor regression grading. No experimental drugs or devices are involved, and all treatments follow standard care protocols. During the study, researchers will collect and analyze blood samples to track miRNA changes and correlate these with cancer subtype and treatment response. They will also examine circulating tumor cell levels and their relationship to outcomes. The primary outcome is the change in circulating miRNA expression before and after NAC. The study aims to identify minimally invasive biomarkers that could improve prediction of chemotherapy response and support personalized treatment planning. Participation involves routine clinical evaluations and blood draws, with the study expected to run until December 2026.
CONDITIONS
Brief Title
Circulating microRNAs and Response to Neoadjuvant Chemotherapy in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed breast cancer
- Planned to receive neoadjuvant chemotherapy
- Biologically female
- Age 218 years or older
- Ability to provide informed consent
- Adequate organ function to receive standard neoadjuvant chemotherapy based on routine clinical evaluation
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of neoadjuvant chemotherapy period
Participants who undergo routine neoadjuvant chemotherapy are observed, with serum samples collected before starting chemotherapy and after completing chemotherapy but before surgery to evaluate microRNA expression.
2 visits (in-person) for blood sample collection
Trial Site Locations
Total: 1 location
1
Istanbul Atlas University Faculty of Medicine
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
E
Emine Yildirim, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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