Tumor Integrating Gut Microbiota in bREast Cancer

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery for breast cancer

Procedure

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

Other names: Characterization of intratumoral microbiota

Primary outcomes

Breast cancer-associated microbial signatures

Time frame: 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 outcomes

Comparison of microbial signatures

Time frame: 12 months

To compare microbial signatures between tumor and adjacent normal tissue (paired design)
Association between microbial and host features

Time frame: 12 months

To explore associations between intratumoral microbial features and clinicopathologic and host variables

Study contacts

Contact information is provided by the study sponsor or research team.

Brunella Posteraro

CONTACT

[email protected]

+3906030157959

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: TIGER-BC

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Nov 28, 2025
Registry last updated: Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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