Triple-negative breast cancer (TNBC) is an aggressive subtype of cancer characterized by substantial heterogeneity in treatment response. Despite significant advances in therapeutic strategies, it remains difficult to accurately predict which patients will derive the greatest benefit from treatment. For this reason, identifying novel factors that may contribute to understanding and predicting treatment response became a conisiderable research priority.
In recent years, increasing evidence has highlighted the potential role of microorganisms present in the intestine (intestinal microbiota) and within tumor tissue (intratumoral microbiota) in modulating immune system activity and influencing the efficacy of anticancer treatments. At the same time, the composition and the functional state of immune cells within the tumor, known as the tumor immune microenvironment (TIME), represent important determinant in the host's ability to build a response against the disease.
In addition, small particles released by cells, known as extracellular vescicles (EVs), circulate in the blood and carry biological information reflecting the characteristics of their cells of origin. EVs analyisis may therefore provide a minimally invasive tool to monitor the disease and predict response to treatment through blood sampling.
This study aims to further investigate the role of intratumoral microbiota and tumor microenvironment in patients with TNBC. A better understanding of the interactions of these components with fecal microbiota and extracellular vescicles may contribute to the identification of new predictive biomarkers and, in the future, support the development of more personalized and effective therapeutic strategies.
Female subjects
Diagnosis of triple-negative breast cancer (TNBC)
Aged 18 years or older
Indication for neoadjuvant treatment with chemotherapy or chemo/immunotherapy.
Patients that have already been treated with chemotherapy.
Patients that did not receive an official cyto-histological diagnosis of breast cancer.
Patients affected by other solid tumors other than breast cancer.
Patients who have undergone antibiotic therapy within the 10 days prior to sample collection.
The study population will include patients referred to the Breast Unit of IRCCS ICS Maugeri of Pavia and the Istituto Nazionale dei Tumori of Milan, diagnosed with triple-negative breast cancer and scheduled for neoadjuvant treatment followed by surgery.
Cohort
Prospective
Not listed
Intratumoral microbiota characterization
Measure of Staphylococcus spp. levels in tumor tissue
Tumor immune microenvironment characterization
Measure of Treg and TAM in tumor tissue
Extracellular vescicles analysis
Extracellular vescicles level on plasma samples
Correlation between intratumor and fecal microbiota profiles
Correlation of bacterial species composition and microbial diversity between intratumor and fecal samples at different time points. Microbiota profiles will be assessed by bacterial species identification and alpha and beta diversity indexes.
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Istituti Clinici Scientifici Maugeri SpA
Lead sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborator
