Tumor Integrating Gut Microbiota in bREast Cancer

Intratumoral Microbiota in Breast Cancer: A Prospective Discovery Study Integrating Tumor/Adjacent Normal Tissue, Estrobolome, and Gut Microbiota Analyses, With Stratification by Molecular Subtypes

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07253168

Acronym

TIGER-BC

Enrollment

240

Registered

2025-11-28

Start date

2025-12-01

Completion date

2028-12-01

Last updated

2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief 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

Interventions

PROCEDURESurgery for breast cancer

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Breast cancer-associated microbial signatures	12 months	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

Secondary

Measure	Time frame	Description
Comparison of microbial signatures	12 months	To compare microbial signatures between tumor and adjacent normal tissue (paired design)
Association between microbial and host features	12 months	To explore associations between intratumoral microbial features and clinicopathologic and host variables

Contacts

Primary ContactBrunella Posteraro

brunella.posteraro@unicatt.it+3906030157959

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026