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NCT05871788

Biomarkers in Patients With Metastatic Breast Cancer

Sponsor: Tunisian Association for Immuno-oncology Research

View on ClinicalTrials.gov

Summary

In order to allow Tunisian patients with breast cancer to access immunotherapies, and innovative treatments to extend life expectancy of patients with breast cancer with a poor prognosis, it is important to study the epidemiological profile of Tunisian cancers breast, in terms of PD-L1 expression, tumor mutational burden (TMB), microsatellite instability status (MSI) and rate of TILs, in metastatic and locally advanced cases, in Tunis, over a one-year follow-up period. It is also important to study other inflammatory and tumor biomarkers which would have a prognostic or even therapeutic value: * serum dosage of LDH (lactate dehydrogenase) * IL-6 (interleukin 6) * CRP (C-reactive protein) * absolute count of lymphocytes (CLA) and eosinophils * quantification of circulating tumor DNA before treatment and under treatment. The primary objective id to identify the epidemiological profile of the biological signature (PD-L1 / TMB / MSI/HRD/ TILs) of patients with locally advanced or metastatic breast carcinoma before and during the systemic treatment.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1600

Start Date

2023-06

Completion Date

2027-12

Last Updated

2023-05-23

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

identify biomarkers

Identify the epidemiological profile of the biological signature (PD-L1 / TMB / MSI/HRD/ TILs) of patients with locally advanced or metastatic breast carcinoma