Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery for breast cancer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients undergoing surgery for breast cancer
- description
- single-arm discovery study with consecutive enrollment of eligible patients undergoing surgery for primary breast cancer
- interventionNames
- Procedure: Surgery for breast cancer
Primary outcomes (1)
- measure
- Breast cancer-associated microbial signatures
- timeFrame
- 12 months
- description
- 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 (2)
- measure
- Comparison of microbial signatures
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available