Extracellular Vesicles in Breast Cancer Patientsin Undergone Neoadjuvant Chemotherapy

May 15, 2025 updated by: Fabio Corsi, Istituti Clinici Scientifici Maugeri SpA

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

Extracellular vesicles (EVs) are lipid bilayer-delimited particles, naturally released from the cells and mediators of intercellular cross-talk. In breast cancer (BC), EVs seem to be involved in the tumor microenvironment's shaping, in cancer cells invasion and in the set-up of metastasis.

Clinical studies have provided initial evidence that EVs may have a prognostic and predictive value in breast cancer. Considering their presence in body fluids and their minimally invasive assessment through blood sampling, EVs could be liquid biopsy-derived biomarkers. Their quantification could be a complex challenge, requiring complicated and time-consuming pre-analytical procedures of EVs isolation.

A new method for the detection of tumor-derived-EVs associated proteins is based on the use of Single Molecule Array (SiMoA), a digital ELISA technology able to detect and quantify extremely low concentrations of target proteins or particles.

The aim of this study is to evaluate how this new technology can allow the quantification EVs plasma levels in patients affected by BC, providing useful diagnostic and prognostic information about the efficacy of the neoadjuvant treatment.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is a prospective, observational, monocentric and no profit study. The study involves the analysis of plasma from patients with breast cancer to quantify and characterize tumor-derived EVs at specific disease stages, and to evaluate the efficacy of the neoadjuvant treatment.

BC patients will be consequently included, at any TNM stage, undergoing neoadjuvant chemotherapy referring to an EUSOMA-accredited Breast Unit.

Patients will be divided into two groups, as follows:

  • Population 1: female patients diagnosed with breast cancer, at any TNM stage, who are candidate to neoadjuvant treatment.
  • Population 2: a control group of sex and age matched healthy volunteers, not affected by breast cancer (with negative mammography, breast ultrasound or breast examination within 12 months of the study enrolment).

For each BC patient, 4 blood samples will be collected at established time-points and plasma will be isolated. Blood samples will be collected as follows: the first sample (T0) before the first chemotherapy infusion; the second sample (T1) before the second chemotherapy infusion (Day 21); the third sample (T2) after the last chemotherapy infusion and before the surgical treatment (between 21 and 42 days after the last chemotherapy infusion); fourth and last sample 1 month after surgery (T3).

A new SiMoA assay, based on the use of anti-CD63 and anti-CD9 antibodies, will be used to quantify EVs directly from plasma without requiring any prior sample processing.

The study will be conducted following the International Conference on Harmonization [ICH] Good Clinical Practice [GCP] guidelines.

Study Type

Observational

Enrollment (Estimated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

  • Population 1: female patients diagnosed with breast cancer, at any TNM stage, who are candidate to neoadjuvant treatment.
  • Population 2: a control group of sex and age matched healthy volunteers, not affected by breast cancer (with negative mammography, breast ultrasound or clinical breast examination within 12 months of the study enrolment).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast cancer patients candidate for neoadjuvant chemotherapy
Female patients diagnosed with breast cancer, at any TNM stage, who are candidate to neoadjuvant treatment.
Healty control
Control group (sex and age matched): healthy volunteers, not affected by breast cancer (with negative mammography, breast ultrasound or breast examination within 12 months of the study enrolment).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EVs levels
Time Frame: 78 months
Measurement of plasma EVs levels (by Simoa-Elisa) in BC patients at the moment of diagnosis and comparison between EVs concentration in BC patients' and healthy controls.
78 months
EVs levels in time
Time Frame: 78 months
Evaluation of tumor-related EVs as predictive markers of neoadjuvant treatment efficacy in BC patients. This will be conducted comparing EVs level during different collected times
78 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2021

Primary Completion (Estimated)

December 21, 2027

Study Completion (Estimated)

December 21, 2027

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 15, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2540

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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