Breast CancerExoTSS-BCNCT07500129
Tissue- and Serum-Derived Exosomal microRNAs as Predictors of Neoadjuvant Chemotherapy Response in Breast Cancer
An observational study of Breast Cancer and Invasive Breast Carcinoma, run by Atlas University.
Trial summary
This prospective observational study aims to evaluate whether exosomal microRNA profiles derived from tumor tissue and blood serum are associated with pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Invasive Breast Carcinoma, Exosomal microRNA
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2026to 22 Apr 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients aged 18 years or older will be enrolled into two cohorts: 1. patients with histologically confirmed breast cancer who are scheduled to receive neoadjuvant chemotherapy, and 2. patients with histologically confirmed benign breast disease. Participants will be recruited from multiple clinical centers. Only leftover tumor tissue and serum samples obtained during routine diagnostic or therapeutic procedures will be used for exosomal microRNA analysis.
Who may be able to join
- Female patients aged 18 years or older
- Histologically confirmed locally advanced breast cancer scheduled to receive neoadjuvant chemotherapy
- Availability of residual tumor tissue and/or serum samples obtained during routine clinical care
- Ability to provide written informed consent
Who cannot join
- Male sex
- Age under 18 years
- Prior systemic chemotherapy or radiotherapy administered for the current breast disease before enrollment.
- Evidence of metastatic disease at diagnosis (for breast cancer cohort)
- Pregnancy or breastfeeding
- Any condition that precludes the availability or adequate quality of tissue or blood samples for research purposes
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Mechanistic Validation of a Tumor-Derived Extracellular Vesicle-Associated miRNA Signature Predicting Response to Neoadjuvant Chemotherapy in Breast Cancer
This prospective observational study aims to evaluate whether exosomal microRNA profiles derived from tumor tissue and blood serum are associated with pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) in patients with breast cancer.
Breast cancer patients with similar clinical and pathological features may respond differently to treatment, underscoring the need for reliable biomarkers that can help predict therapeutic outcomes. Exosomes are small extracellular vesicles released by tumor cells that carry molecular signals, including microRNAs, which may reflect tumor behavior and treatment sensitivity.
Read more
In this study, patients with breast cancer receiving standard NAC as part of routine clinical care will be followed prospectively. Exosomal microRNA profiles obtained from tumor tissue and blood samples collected during routine diagnostic and treatment procedures will be analyzed and compared with pathological complete response (pCR) assessed after completion of neoadjuvant chemotherapy.
A group of patients with benign breast disease will be included as a reference control for comparative analyses.
The results of this study may contribute to the identification of minimally invasive biomarkers that support personalized treatment strategies in breast cancer.
Read the detailed description
This prospective, multicenter, non-interventional observational study is designed to investigate tissue- and serum-derived exosomal microRNA profiles and their association with pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) in patients with locally advanced breast cancer (LABC).
Although established clinicopathological parameters, including hormone receptor status, Human Epidermal Growth Factor Receptor 2 (HER2) expression, and Ki-67 index, are routinely used to stratify breast cancer subtypes and provide important prognostic and predictive information, inter-patient variability in treatment response remains substantial. These parameters do not fully capture the dynamic biological heterogeneity of tumors or reliably predict individual response to neoadjuvant chemotherapy in all patients. This underscores the need for additional, minimally invasive molecular biomarkers that may complement existing clinicopathological factors and better reflect tumor biology, thereby supporting personalized therapeutic strategies.
Exosomes are small extracellular vesicles released by tumor and stromal cells that carry molecular cargo, including microRNAs, which reflect the biological activity of their cells of origin. Due to their stability and detectability in both tumor tissue and peripheral blood, exosomal microRNAs represent promising candidates for monitoring treatment response and identifying mechanisms of chemotherapy sensitivity or resistance.
In this study, patients with histologically confirmed locally advanced breast cancer who are scheduled to receive standard-of-care neoadjuvant chemotherapy will be prospectively enrolled. The study is strictly observational, and no additional interventions, blood draws, tissue biopsies, or sample collection procedures will be performed for research purposes. Exosomal miRNA analyses will be conducted exclusively on residual serum samples obtained during routine clinical blood tests and leftover tumor tissue collected for diagnostic or surgical purposes as part of standard clinical care.
Exosomal microRNA expression profiles derived from tissue and serum samples will be analyzed using molecular techniques and correlated with pathological complete response (pCR) following completion of neoadjuvant chemotherapy. Pathological response will be evaluated using established tumor regression grading systems, including pathological complete response (pCR) and standardized tumor regression grading criteria.
In addition, residual samples obtained from patients with histologically confirmed benign breast lesions will be included as a reference control group to assess the specificity of molecular alterations observed in malignant disease.
The primary objective of the study is to evaluate whether tissue- and serum-derived exosomal microRNA expression patterns are associated with pathological complete response (pCR) to neoadjuvant chemotherapy. Secondary objectives include comparing tissue- and serum-based exosomal microRNA profiles, exploring associations with clinicopathological variables, and assessing the potential of exosomal microRNAs as predictive biomarkers of treatment sensitivity or resistance.
- Conditions
- Breast Cancer, Invasive Breast Carcinoma, Exosomal microRNA, Neoadjuvant Chemotherapy Response, Pathological Complete Response
- Keywords
- Breast Cancer, Breast Cancer Biomarkers, Exosomal microRNA, Circulating microRNA, Tissue-derived exosomes, Serum-derived exosomes, Pathological Complete Response
- 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 + NAC Cohort | Patients with histologically confirmed locally advanced breast cancer who are scheduled to receive standard-of-care neoadjuvant chemotherapy. No additional tissue or blood samples will be collected for research purposes; only residual tumor tissue and serum obtained during routine clinical care will be used for exosomal microRNA analysis. Molecular findings will be correlated with pathological complete response (pCR) after treatment. | |
| Benign Breast Disease Control Cohort | Patients with histologically confirmed benign breast lesions. No additional tissue or blood samples will be collected for research purposes; only residual tissue and serum obtained during routine diagnostic or therapeutic procedures will be used for exosomal microRNA profiling to serve as a non-malignant control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate after neoadjuvant chemotherapy
The primary outcome is pathological complete response (pCR), defined as the absence of residual invasive cancer in the breast and axillary lymph nodes (ypT0/is, ypN0), assessed using standard pathological evaluation after completion of neoadjuvant chemotherapy.
Measured: At time of surgery, after completion of neoadjuvant chemotherapy (approximately 4-8 months after baseline)
Secondary outcomes (1)
Baseline exosomal microRNA expression levels in breast tissue and serum
Exosomal microRNA expression levels will be measured in tumor tissue and serum samples collected at baseline using standardized molecular analysis methods (e.g., qRT-PCR or RNA sequencing). Expression levels will be quantitatively analyzed and compared across pathological response categories (pathological complete response, partial response, and no response).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start12 Apr 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion22 Apr 2027 (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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine YILDIRIM, Atlas University
- Investigators
- EMİNE YILDIRIM, Principal investigator, Atlas University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500129
- Sponsor's protocol ID
- BreastExoTSS-microRNA
- Acronym
- ExoTSS-BC
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data sharing has not yet been determined. Any future data sharing will be subject to ethical approval, institutional regulations, and applicable data protection laws. De-identified data may be considered for sharing upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Mechanistic Validation of a Tumor-Derived Extracellular Vesicle-Associated miRNA Signature Predicting Response to Neoadjuvant Chemotherapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT07500129
- Acronym / sponsor ID
- ExoTSS-BC / BreastExoTSS-microRNA
- Conditions
- Breast Cancer, Invasive Breast Carcinoma, Exosomal microRNA, Neoadjuvant Chemotherapy Response, Pathological Complete Response
- Keywords
- Breast Cancer, Breast Cancer Biomarkers, Exosomal microRNA, Circulating microRNA, Tissue-derived exosomes, Serum-derived exosomes, Pathological Complete Response
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 12 Apr 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 30 Mar 2026 (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 evaluate whether exosomal microRNA profiles derived from tumor tissue and blood serum are associated with pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) in patients with breast cancer.
Breast cancer patients with similar clinical and pathological features may respond differently to treatment, underscoring the need for reliable biomarkers that can help predict therapeutic outcomes. Exosomes are small extracellular vesicles released by tumor cells that carry molecular signals, including microRNAs, which may reflect tumor behavior and treatment sensitivity.
In this study, patients with breast cancer receiving standard NAC as part of routine clinical care will be followed prospectively. Exosomal microRNA profiles obtained from tumor tissue and blood samples collected during routine diagnostic and treatment procedures will be analyzed and compared with pathological complete response (pCR) assessed after completion of neoadjuvant chemotherapy.
A group of patients with benign breast disease will be included as a reference control for comparative analyses.
The results of this study may contribute to the identification of minimally invasive biomarkers that support personalized treatment strategies in breast cancer.
Detailed description
This prospective, multicenter, non-interventional observational study is designed to investigate tissue- and serum-derived exosomal microRNA profiles and their association with pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) in patients with locally advanced breast cancer (LABC).
Although established clinicopathological parameters, including hormone receptor status, Human Epidermal Growth Factor Receptor 2 (HER2) expression, and Ki-67 index, are routinely used to stratify breast cancer subtypes and provide important prognostic and predictive information, inter-patient variability in treatment response remains substantial. These parameters do not fully capture the dynamic biological heterogeneity of tumors or reliably predict individual response to neoadjuvant chemotherapy in all patients. This underscores the need for additional, minimally invasive molecular biomarkers that may complement existing clinicopathological factors and better reflect tumor biology, thereby supporting personalized therapeutic strategies.
Exosomes are small extracellular vesicles released by tumor and stromal cells that carry molecular cargo, including microRNAs, which reflect the biological activity of their cells of origin. Due to their stability and detectability in both tumor tissue and peripheral blood, exosomal microRNAs represent promising candidates for monitoring treatment response and identifying mechanisms of chemotherapy sensitivity or resistance.
In this study, patients with histologically confirmed locally advanced breast cancer who are scheduled to receive standard-of-care neoadjuvant chemotherapy will be prospectively enrolled. The study is strictly observational, and no additional interventions, blood draws, tissue biopsies, or sample collection procedures will be performed for research purposes. Exosomal miRNA analyses will be conducted exclusively on residual serum samples obtained during routine clinical blood tests and leftover tumor tissue collected for diagnostic or surgical purposes as part of standard clinical care.
Exosomal microRNA expression profiles derived from tissue and serum samples will be analyzed using molecular techniques and correlated with pathological complete response (pCR) following completion of neoadjuvant chemotherapy. Pathological response will be evaluated using established tumor regression grading systems, including pathological complete response (pCR) and standardized tumor regression grading criteria.
In addition, residual samples obtained from patients with histologically confirmed benign breast lesions will be included as a reference control group to assess the specificity of molecular alterations observed in malignant disease.
The primary objective of the study is to evaluate whether tissue- and serum-derived exosomal microRNA expression patterns are associated with pathological complete response (pCR) to neoadjuvant chemotherapy. Secondary objectives include comparing tissue- and serum-based exosomal microRNA profiles, exploring associations with clinicopathological variables, and assessing the potential of exosomal microRNAs as predictive biomarkers of treatment sensitivity or resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer + NAC Cohort | – | –Patients with histologically confirmed locally advanced breast cancer who are scheduled to receive standard-of-care neoadjuvant chemotherapy. No additional tissue or blood samples will be collected for research purposes; only residual tumor tissue and serum obtained during routine clinical care will be used for exosomal microRNA analysis. Molecular findings will be correlated with pathological complete response (pCR) after treatment. |
| Benign Breast Disease Control Cohort | – | –Patients with histologically confirmed benign breast lesions. No additional tissue or blood samples will be collected for research purposes; only residual tissue and serum obtained during routine diagnostic or therapeutic procedures will be used for exosomal microRNA profiling to serve as a non-malignant control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged 18 years or older will be enrolled into two cohorts: 1. patients with histologically confirmed breast cancer who are scheduled to receive neoadjuvant chemotherapy, and 2. patients with histologically confirmed benign breast disease. Participants will be recruited from multiple clinical centers. Only leftover tumor tissue and serum samples obtained during routine diagnostic or therapeutic procedures will be used for exosomal microRNA analysis.
Key inclusion criteria (4 listed)
- Female patients aged 18 years or older
- Histologically confirmed locally advanced breast cancer scheduled to receive neoadjuvant chemotherapy
- Availability of residual tumor tissue and/or serum samples obtained during routine clinical care
- Ability to provide written informed consent
Key exclusion criteria (6 listed)
- Male sex
- Age under 18 years
- Prior systemic chemotherapy or radiotherapy administered for the current breast disease before enrollment.
- Evidence of metastatic disease at diagnosis (for breast cancer cohort)
- Pregnancy or breastfeeding
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
Pathological complete response (pCR) rate after neoadjuvant chemotherapy
Time frame: At time of surgery, after completion of neoadjuvant chemotherapy (approximately 4-8 months after baseline)
The primary outcome is pathological complete response (pCR), defined as the absence of residual invasive cancer in the breast and axillary lymph nodes (ypT0/is, ypN0), assessed using standard pathological evaluation after completion of neoadjuvant chemotherapy.
1 secondary outcome
Baseline exosomal microRNA expression levels in breast tissue and serum
Time frame: Baseline
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 30 Mar 2026.
- Institutional website of Atlas University, the sponsor and coordinating center of this studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Individual participant data sharing has not yet been determined. Any future data sharing will be subject to ethical approval, institutional regulations, and applicable data protection laws. De-identified data may be considered for sharing 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.
EMİNE YILDIRIM principal investigator
Atlas University Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Invasive Breast Carcinoma, run by Atlas University.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 EMİNE 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?
Pathological complete response (pCR) rate after neoadjuvant chemotherapy (time frame: At time of surgery, after completion of neoadjuvant chemotherapy (approximately 4-8 months after baseline)). 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 30 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.