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Recruiting NCT07289282

Circulating microRNAs and Response to Neoadjuvant Chemotherapy in Breast Cancer

— Observational Breast Cancer Neoadjuvant Therapy Pathological Response Invasive Breast Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Breast Cancer, Neoadjuvant Therapy, Pathological Response, Invasive Breast Carcinoma. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Relationship Between microRNAs in Breast Cancer Subtypes and Response to Neoadjuvant Chemotherapy and Pathological Response

Overview

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.

Detailed description

This is a prospective, single-center observational study designed to evaluate circulating microRNA (miRNA) expression patterns in breast cancer patients receiving neoadjuvant chemotherapy (NAC). The primary aim is to examine changes in selected miRNAs (including miR-200 family members, miR-34a, miR-221/222, miR-155, and miR-146a) before NAC initiation and prior to surgery, and to determine their association with pathological response.

Participants diagnosed with breast cancer and scheduled to receive standard NAC will be enrolled consecutively. Serum samples will be collected at two time points: (1) before NAC initiation, and (2) following completion of NAC but before surgery. Quantitative RT-PCR methods will be used to measure circulating miRNA expression levels. Pathological response will be evaluated using pathological complete response (pCR) status and Miller-Payne tumor regression grading.

Secondary aims include examining the relationship between miRNA dynamics and breast cancer subtypes, evaluating the potential predictive value of miRNAs for NAC response, and assessing possible correlations between circulating tumor cell (CTC) levels and treatment outcomes. No investigational drugs or devices will be used in this study, and all treatments will follow standard clinical protocols.

The study is expected to contribute to the identification of minimally invasive biomarkers that may support personalized treatment approaches and improve prediction of NAC response in breast cancer.

Primary outcome measures

  • Change in circulating microRNA expression levels before and after neoadjuvant chemotherapy [Time frame: Baseline (before NAC) and pre-surgery (after completion of NAC)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Atlas University Faculty of Medicine — Istanbul

Identifiers

NCT: NCT07289282 · Breast-miRNA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗