Study on patients undergoing surgery for breast cancer. Objective: to characterize the intratumoral microbiota and integrate these findings with clinicopathologic data, the estrobolome, and gut microbiota, with analyses stratified by molecular subtype (Luminal A, Luminal B, HER2-enriched \[human epidermal growth factor receptor 2-enriched\], and TNBC \[triple-negative breast cancer\]). Enrollment: consecutive recruitment in the operating room based on the availability of biopsy/histological material. Samples: tumor tissue, adjacent normal tissue; urine (for indirect assessment of estrobolome activity); and stool. Strict anti-contamination measures will be implemented. Exploratory outcomes: differences across subtypes, associations with features of the TME (tumor microenvironment), including TILs (tumor-infiltrating lymphocytes), and markers of progression or treatment resistance
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
240
To investigate the intratumoral microbiota in breast cancer and integrate these findings with gut microbiota analyses, including estrobolome characterization, to explore potential microbial-host interactions influencing tumor biology across molecular subtypes
Breast cancer-associated microbial signatures
To characterize intratumoral microbial signatures (composition and inferred function) across breast cancer (BC) molecular subtypes (Luminal A, Luminal B, HER2-enriched, TNBC) using contamination-aware pipelines
Time frame: 12 months
Comparison of microbial signatures
To compare microbial signatures between tumor and adjacent normal tissue (paired design)
Time frame: 12 months
Association between microbial and host features
To explore associations between intratumoral microbial features and clinicopathologic and host variables
Time frame: 12 months
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