Breast CancermiRNA-NACNCT07289282
Circulating microRNAs and Response to Neoadjuvant Chemotherapy in Breast Cancer
An observational study of Breast Cancer and Neoadjuvant Therapy, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Neoadjuvant Therapy, Pathological Response
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients diagnosed with breast cancer who are scheduled to undergo standard neoadjuvant chemotherapy at a single tertiary care center.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Atlas University Faculty of Medicine
Istanbul
About this study
Official title: The Relationship Between microRNAs in Breast Cancer Subtypes and Response to Neoadjuvant Chemotherapy and Pathological Response
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.
Read the 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.
- Conditions
- Breast Cancer, Neoadjuvant Therapy, Pathological Response, Invasive Breast Carcinoma, MicroRNAs
- Keywords
- microRNA, Circulating microRNAs, Neoadjuvant Chemotherapy, Pathological Complete Response, Predictive Biomarkers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before NAC) and pre-surgery (after completion of NAC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start15 Dec 2025
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine YILDIRIM, Atlas University
- Investigators
- Emine Yildirim, MD, Principal investigator, Atlas University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289282
- Sponsor's protocol ID
- Breast-miRNA
- Acronym
- miRNA-NAC
- Status last verified
- Nov 2025
- First submitted
- 4 Dec 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and data protection regulations. Only de-identified aggregated results may be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between microRNAs in Breast Cancer Subtypes and Response to Neoadjuvant Chemotherapy and Pathological Response
- ClinicalTrials.gov ID
- NCT07289282
- Acronym / sponsor ID
- miRNA-NAC / Breast-miRNA
- Conditions
- Breast Cancer, Neoadjuvant Therapy, Pathological Response, Invasive Breast Carcinoma, MicroRNAs
- Keywords
- microRNA, Circulating microRNAs, Neoadjuvant Chemotherapy, Pathological Complete Response, Predictive Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients diagnosed with breast cancer who are scheduled to undergo standard neoadjuvant chemotherapy at a single tertiary care center.
Key inclusion criteria (6 listed)
- Histologically confirmed breast cancer
- Planned to receive neoadjuvant chemotherapy
- Biologically female
- Age ≥ 18 years
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in circulating microRNA expression levels before and after neoadjuvant chemotherapy
Time frame: Baseline (before NAC) and pre-surgery (after completion of NAC)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and data protection regulations. Only de-identified aggregated results may be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emine Yildirim, MD principal investigator
Atlas University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Neoadjuvant Therapy, run by Atlas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emine Yildirim, MD (+905056234825, opdreyildirim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in circulating microRNA expression levels before and after neoadjuvant chemotherapy (time frame: Baseline (before NAC) and pre-surgery (after completion of NAC)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.