Tumor Integrating Gut Microbiota in bREast Cancer (TIGER-BC)

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Not yet enrolling

Conditions

Breast Cancer

Treatments

Procedure: Surgery for breast cancer

Study type

Interventional

Funder types

Other

Identifiers

NCT07253168

8051

Details and patient eligibility

About

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

Enrollment

240 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Women ≥18 years with primary, non-metastatic breast cancer (BC) undergoing surgery.
Availability of sufficient tumor and adjacent normal tissue for research purposes after completion of diagnostic sampling.
Written informed consent

Exclusion criteria

Active systemic infection or fever >38.0°C within 72 h pre-surgery.
Antibiotics within 14 days pre-sampling (recorded; analyses adjusted).
Prior ipsilateral BC surgery for current lesion (except re-excision with fresh tissue).
Any condition preventing compliance with the study protocol.