Clinical trial Recruiting at 1 site Observational Ages 18 to 80 Women only

Analyzing extracellular vesicles in breast cancer patients undergoing chemotherapy

Official title: Extracellular Vesicles as a Diagnostic and Prognostic Biomarker of Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients.

Run by Istituti Clinici Scientifici Maugeri SpA · NCT05831397 · Data updated 2026-11-12

This study is trying to see if tiny particles from tumors in breast cancer patients getting chemotherapy can help doctors understand how well the treatment is working compared to healthy people.

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexWomen only
Enrollment35 (estimated)
SponsorIstituti Clinici Scientifici Maugeri SpA
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Pavia, Lombardy)
StatusRecruiting
StartedMay 11, 2021
Main results expectedDecember 21, 2027
Study endsDecember 21, 2027
Registry record updatedJuly 6, 2026
Trial IDNCT05831397 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are female patients diagnosed with breast cancer at any TNM stage who are indicated for neoadjuvant chemotherapy.

Probably not a fit

Patients who are indicated for upfront surgery or those with a diagnosis of breast cancer in the control group will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the presence and characteristics of tumor-derived extracellular vesicles (EVs) in breast cancer patients receiving neoadjuvant chemotherapy. It involves collecting plasma samples from participants at various stages of treatment to quantify EVs using a novel detection method called Single Molecule Array (SiMoA). The study will include both breast cancer patients and a control group of healthy volunteers to compare the findings. The goal is to assess the potential of EVs as biomarkers for treatment efficacy and disease progression.

Why it matters

Potential benefit: If successful, this study could provide a minimally invasive method for monitoring treatment response in breast cancer patients.

How similar studies have gone: Other studies have shown promise in using extracellular vesicles as biomarkers in cancer, but this specific approach with SiMoA is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Signing of a specific informed consent for participation to the study
* Female sex

BC patients:

* Diagnosis of breast cancer
* Any TNM stage
* Indication to neoadjuvant chemotherapy after multidisciplinary discussion

Healthy controls:

• Patients with a negative mammography, breast ultrasound or clinical breast evaluation within 12 months of the study enrolment

Exclusion Criteria:

BC patients:

• Indication to upfront surgery

Healthy controls:

• Diagnosis of breast cancer

Where it's running

  • Istituti Clinici Scientifici Maugeri SpA
    Pavia, Lombardy, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.