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Breast Cancer · Observational Study
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a recruiting observational study designed to characterize intratumoral microbiota and tumor immune microenvironment in triple-negative breast cancer patients undergoing neoadjuvant therapy. The study has not yet enrolled or published results and aims to identify potential predictive biomarkers through microbiota and immune profiling.
Observational. Breast Cancer; Female; age from 18 Years. Intervention: Characterization of intratumoral microbiota, tumor immune microenvironment, fecal microbiota, and extracellular vesicles at baseline and post-neoadjuvant therapy. n = 30. 1 site: Italy.
This is a recruiting observational study designed to characterize intratumoral microbiota and tumor immune microenvironment in triple-negative breast cancer patients undergoing neoadjuvant therapy. The study has not yet enrolled or published results and aims to identify potential predictive biomarkers through microbiota and immune profiling.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This study is exploratory and may eventually contribute to biomarker-driven personalization of TNBC therapy, but results are not yet available. Clinicians should not alter practice based on this registry entry alone.
This is a recruiting observational study with no posted results; it aims to characterize microbiota and immune features as potential biomarkers in triple-negative breast cancer but has not yet generated outcome data.
As stated by the source record.
Quoted from the source exactly as published.
This study is exploratory and may eventually contribute to biomarker-driven personalization of TNBC therapy, but results are not yet available. Clinicians should not alter practice based on this registry entry alone.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07808086). This is a study registration, not published results. Lead sponsor: Istituti Clinici Scientifici Maugeri SpA. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Breast Cancer. Primary outcome measures: Intratumoral microbiota characterization , From diagnostic biopsy (first time point) and at surgery (second time point).; Tumor immune microenvironment characterization , From diagnostic biopsy (first time point) and at surgery (second time point).. Brief summary: Triple-negative breast cancer (TNBC) is an aggressive subtype of cancer characterized by substantial heterogeneity in treatment response. Despite significant advances in therapeutic strategies, it remains difficult to accurately predict which patients will derive the greatest benefit from treatment. For this reason, identifying novel factors that may contribute to understanding and predicting treatment response became a conisiderable research priority. In recent years, increasing evidence has highlighted the potential role of microorganisms present in the intestine (intestinal microbiota) and within tumor tissue (intratumoral microbiota) in modulating immune system activity and influencing the efficacy of anticancer treatments. At the same time, the composition and the functional state of immune cells within the tumor, known as the tumor immune microenvironment (TIME), represent important determinant in the host's ability to build a response against the disease. In addition, small particles released by cells, known as extracellular vescicles (EVs), circulate in the blood and carry biological information reflecting the characteristics of their cells of origin. EVs analyisis may therefore provide a minimally invasive tool to monitor the disease and predict response to treatment through blood sampling. This study aims to further investigate the role of intratumoral microbiota and tumor microenvironment in patients with TNBC. A better understanding of the interactions of these components with fecal microbiota and extracellular vescicles may contribute to the identification of new predictive biomarkers and, in the future, support the development of more personalized and effective therapeutic strategies.
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