Extracellular Vesicles in Breast Cancer Patientsin Undergone Neoadjuvant Chemotherapy

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.

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