Circulating microRNA changes to predict neoadjuvant chemotherapy response in breast cancer.
The Relationship Between microRNAs in Breast Cancer Subtypes and Response to Neoadjuvant Chemotherapy and Pathological Response
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 |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Atlas University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07289282 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (biologically female) with histologically confirmed non-metastatic breast cancer who are planned for standard neoadjuvant chemotherapy and can provide informed consent.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Istanbul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.