Clinical trial · Observational
Biomarkers in Patients With Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Identify the Number of Eligible Patients for Immunotherapy According to the Epidemiological and Biological Profile in Tunisia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| identify biomarkers | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- number of eligible patients for immunotherapy
- timeFrame
- 2023 to 2027
- description
- Identify the number of eligible patients for immunotherapy according to the epidemiological and biological profile
Secondary outcomes (1)
- measure
- Relevance of immunotherapy in Tunisia
- timeFrame
- 2023 to 2027
- description
- Assess the relevance of the introduction of immunotherapy in Tunisia, by calculating the extension of the life expectancy (without disease and overall) of the patients who could benefit from this treatment, compared to the cost. \- Identify the sub-population of patients who benefit most from immunotherapy in Tunisia
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old. * Signed informed consent * Histological evidence of breast carcinoma. * Locally advanced (stage III inoperable) or metastatic (stage IV) carcinoma, the metastases of which have been diagnosed straight away or after adjuvant or neoadjuvant treatment. * No treatment for metastatic disease. * Metastatic disease: histological evidence of metastasis * Patients who will receive systemic treatment (chemotherapy, targeted therapy, hormone therapy) * Life expectancy greater than 3 months Exclusion Criteria: * Non-epithelial breast cancer * Non-biopsiable metastases * Patients who have received before systemic treatment for metastatic disease (chemotherapy, targeted therapy, hormone therapy) * Patients with a contraindication to chemotherapy, and / or hormone therapy, and / or targeted therapy. * Foreign patients
References
Publications (0)
Data not yet available