Tumor Integrating Gut Microbiota in bREast Cancer

NCT07253168 | Not Yet Recruiting

• 1 other identifier: 8051
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (2)

• Comparison of microbial signatures

  12 months

• Association between microbial and host features

  12 months

Study Arms (1)

Patients undergoing surgery for breast cancer

EXPERIMENTAL

single-arm discovery study with consecutive enrollment of eligible patients undergoing surgery for primary breast cancer

Procedure: Surgery for breast cancer

Interventions

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

Also known as: Characterization of intratumoral microbiota

Patients undergoing surgery for breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Brunella Posteraro

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brunella Posteraro

CONTACT

+3906030157959; brunella.posteraro@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-10