Characterization of Innate Immune System in Patients With Luminal Advanced Breast Cancer

Exclusion criteria

• ✕. Female ≥ 18 years of age on day of signing informed consent.
• ✕. Patient with histological confirmation of BC with evidence of metastatic or advanced disease not amenable to resection or radiation therapy with curative intent.
• ✕. Documented Hormonal Receptor (HR) positive status based on local testing (preferably assessed on the most recent tumour biopsy available). HR+ is defined as ≥ 1% positive cells by immuno-histochemistry (IHC) for ER and/or Progesterone Receptor (PgR).
• ✕. Documented HER2 negative status based on local testing (preferably assessed on the most recent tumour biopsy available). HER2- is defined as IHC score 0/1+ or negative by in situ hybridization according to local criteria.
• ✕. Patients who are going to receive ET in first or second line for advanced disease (in monotherapy or in combination). It is allowed the inclusion of patients that have received or are going to initiate tamoxifen, Luteinizing Hormone Releasing Hormone (LHRH) analogues, aromatase inhibitors or fulvestrant. It is also possible to recruit patients that have received or are going to initiate cyclin or mTOR inhibitors in combination with ET. (NOTE: it is not allowed the inclusion of patients after first line of chemotherapy that are in response and initiate maintenance ET).
• ✕. Patients who have participated in the study during their first line of ET are eligible to participate again when they receive the second line of ET (in this case eligibility criteria should be checked newly and ICF signed again).