Circulating microRNA changes to predict neoadjuvant chemotherapy response in breast cancer.
Official title: The Relationship Between microRNAs in Breast Cancer Subtypes and Response to Neoadjuvant Chemotherapy and Pathological Response
Run by Atlas University · NCT07289282 · Data updated 2026-11-12
This will test whether changes in blood microRNA levels before and after chemotherapy can help predict who will have a strong tumor response to neoadjuvant chemotherapy for breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | Atlas University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | August 2026 |
| Study ends | December 2026 |
| Registry record updated | March 31, 2026 |
| Trial ID | NCT07289282 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (biologically female) with histologically confirmed non-metastatic breast cancer who are planned for standard neoadjuvant chemotherapy and can provide informed consent.
✕Probably not a fit
Patients with metastatic disease at diagnosis, those who have already received systemic chemotherapy for their breast cancer, or individuals unable to provide required blood samples (including pregnant or breastfeeding patients, who are excluded) are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center observational project enrolls adults with histologically confirmed breast cancer who are scheduled to receive standard neoadjuvant chemotherapy. Serum samples are collected before starting chemotherapy and again after completing chemotherapy but before surgery, and selected circulating microRNAs (including the miR-200 family, miR-34a, miR-221/222, miR-155, and miR-146a) are measured by quantitative RT-PCR. Pathological response is determined using pathological complete response (pCR) status and Miller-Payne tumor regression grading at surgery, and analyses will examine associations between miRNA dynamics, breast cancer subtypes, and circulating tumor cell levels. No investigational drugs or devices are used and all treatments follow routine clinical care.
Why it matters
Potential benefit: If successful, the findings could lead to a simple blood-based biomarker to help personalize neoadjuvant chemotherapy and better predict which patients will achieve a complete pathological response.
How similar studies have gone: Previous studies have reported promising associations between certain circulating microRNAs and chemotherapy response, but results are heterogeneous and not yet validated for routine clinical use.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Where it's running
-
Istanbul Atlas University Faculty of Medicine
Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Emine Yildirim, MD — Atlas University Faculty of Medicine
- Study coordinator: Emine Yildirim, MD
- Email: opdreyildirim@gmail.com
- Phone: +905056234825
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.