This is an experimental, prospective and monocentric study. This study involves consecutive patients with diagnosis of breast cancer (BC), including early breast cancer and metastatic breast cancer patients, referring to the Breast Unit and to the Oncology Department at Istituti Clinici Scientifici Maugeri, Pavia (Italy).
Patients diagnosed with different histological types of breast cancer will be enrolled in the study: luminal BC, HER2-enriched BC, triple-negative BC.
The study duration is 24 months, starting from December 2022 to December 2024.
The patients will be divided into three groups, as follows:
* Population 1: patients diagnosed with metastatic breast cancer.
* Population 2: patients diagnosed with primary early-breast cancer candidate for surgery.
* Population 3: a control group of sex and age matched healthy volunteers, not affected by any neoplastic disease.
For each patient, a 15 ml EDTA blood sample will be collected at different time-points, as follows:
* Population 1: before starting a potential chemotherapy treatment.
* Population 2: before undergoing surgical procedure.
* Population 3: at the first useful moment. The blood samples will be collected at the Maugeri Institute and CTCs will be isolated within 48 hours to validate the device.
For each patient, the following clinico-anamnestic information will be collected: age, histological tumour information at diagnosis (tumour subtype, grading, receptors' status, Ki-67 value), histological metastases information, clinical stage (clinical TNM), type of surgery, pathological staging after surgery (pTNM).
