Biomarkers in Patients With Metastatic Breast Cancer

Procedure:

1. Verification of the inclusion / non-inclusion criteria
2. Signing the consent form
3. Surgical, Medical and family history, ongoing treatments
4. Clinical Examination1
5. Radiological examinations 2
6. TNM Classification (Appendix 3)
7. Standard biochemical assessment 3
8. Inflammatory assessment (CRP, LDH, IL6)
9. Hematological assessment (NFS, platelets)
10. Tumor markers (ACE, CA15-3)
11. Histological and molecular examination 4:

• Expression PD-L1 by IHC (Immuno-Histochemistry)
• TILs by IHC
• • MSI status: MMR * proteins (Mismatch Repair Protein) (Appendix 4) by NGS via TruSight™ Oncology 500 Kit (Illumina) , if PD-L1>1%
• Score HRD : by NGS via TruSight™ Oncology 500 Kit (Illumina) , if PD-L1>1%
• TMB mutational burden by next generation sequencing "Next Generation Sequencing" (NGS) via TruSight™ Oncology 500 Kit (Illumina) if PD-L1>1%
• tDNA by digital PCR

12. Radiological evaluation5
13. Indication of surgery? (if yes type of surgery to be specified)
14. Evaluation of adverse events / effects: Tolerance of the previous treatment
15. Completion the source documents and the eCRF

Clinical Exam1:

• General State according to the WHO classification or according to the Karnowsky Index
• Breast examination: inspection (symmetry, appearance of the skin), palpation (size of the tumor, presence of mammary discharge).
• Examination of the axillary and supraclavicular lymph node areas
• Abdominal examination
• Pulmonary auscultation
• Skeleton examination Radiological examination2:
• Mammography and echo-mammary
• Thoraco-abdomino-pelvic CT scan
• Bone scintigraphy
• Cardiac ultrasound

Standard biochemical balance3: