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Evaluation of soluble PD-L1 in combination with its protein expression in circulating tumor cells and other soluble factors as serum markers of treatment response in patients with Non-Metastatic Triple Negative Breast Cancer

Grant number: 22/15151-3
Support Opportunities:Scholarships in Brazil - Doctorate
Effective date (Start): July 01, 2023
Effective date (End): June 30, 2027
Field of knowledge:Biological Sciences - Immunology - Cellular Immunology
Principal Investigator:Ludmilla Thomé Domingos Chinen
Grantee:Jacqueline Aparecida Torres
Host Institution: Instituto Brasileiro de Controle do Cancer (IBCC). São Paulo , SP, Brazil


Immunotherapy has provided beneficial results for cancer patients. Recently, the ANVISA, based on the KEYNOTE-355 study, approved the use of the immune checkpoint inhibitor (ICI) pembrolizumab plus chemotherapy for patients with unresectable locally recurrent or metastatic triple-negative breast cancer, with PD-L1 expression e 10. Although the results are encouraging, evidence suggests that only a fraction of patients benefit from treatment and may have serious immune-related adverse events. To minimize reactions to ICIs, it is importante to establish predictive biomarkes of response, and blood biomarkes are na option due to non-invasive nature. Laboratory values such a neutrophils-lymphocytes ratio (NLR), the presence of soluble PD-L1 (sPD-L1), of secreted cytokines (TGF-², IL-8) and PD-L1 expression in circulating tumor cells are potential predictive biomarkers. Objective: To verify if the sequential analysis of sPD-L1, PD-L1 expressed in CTCs, soluble TGF-² and IL-8 and NLR can be predictive factors for patients with TNBC stages I-III; to verify if there is a relationship between sPD-L1, PD-L1 expressed in CTCs, soluble TGF-² and IL-8 and NLR and invasive disease-free survival in stage I-III patients. Methodology: we will collect blood samples at 2 times (T1: before treatment at the clinician's choice) (T2: 6 months after treatment) 10mL peripheral blood in EDTA tubes to CTCs enrichment using the ISET methodology and 2mL blood for analysis of sérum biomarkers (sPD-L1, TGF-² e IL-8) by ELISA assay. We will calculate the NLR based on medical record data and we will do immunocytochemical assay for PD-L1 on CTCs. In this way, we hope to contribute to the personalization of the treatment of patients with TNBC in early stages. (AU)

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