Circulating microRNAs and Response to Neoadjuvant Chemotherapy in Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAtlas University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed breast cancer
Planned to receive neoadjuvant chemotherapy
Biologically female
Age ≥ 18 years
Disqualifiers
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
Trial population
Female patients diagnosed with breast cancer who are scheduled to undergo standard neoadjuvant chemotherapy at a single tertiary care center.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 1 trial groupGroup A: Breast Cancer Cohort
Trial outcomes
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.
Time frame
Baseline (before NAC) and pre-surgery (after completion of NAC)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov