Clinical Trial

Tumor Integrating Gut Microbiota in bREast Cancer

Study acronym: TIGER-BC
Not Yet Recruiting
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Summary
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
Trial Details
NCT Number NCT07253168
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Breast Cancer
Enrollment 240 participants
Start Date 2025-12-01
Primary Completion 2027-12-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-28