Clinical trial · Observational
Role of Tumor Microbiota in the Response to Neoadjuvant Therapy in Patients Affected by Triple Negative Breast Cancer
Study of the Role of the Tumor Microbiota in the Neoadjuvant Therapy Response on Triple Negative Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Intratumoral microbiota characterization
- timeFrame
- From diagnostic biopsy (first time point) and at surgery (second time point).
- description
- Measure of Staphylococcus spp. levels in tumor tissue
- measure
- Tumor immune microenvironment characterization
- timeFrame
- From diagnostic biopsy (first time point) and at surgery (second time point).
- description
- Measure of Treg and TAM in tumor tissue
Secondary outcomes (2)
- measure
- Extracellular vescicles analysis
- timeFrame
- From diagnostic biopsy (first time point) and at surgery (second time point).
- description
- Extracellular vescicles level on plasma samples
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female subjects * Diagnosis of triple-negative breast cancer (TNBC) * Aged 18 years or older * Indication for neoadjuvant treatment with chemotherapy or chemo/immunotherapy. * Patients willing and able to comply to standard oncological follow-up procedures. * Subjects who agree to participate in the present study by signing and dating the informed consent form. Exclusion Criteria: If a subject meets any of the following criteria, they must be excluded from the study. * Patients that have already been treated with chemotherapy. * Patients that did not receive an official cyto-histological diagnosis of breast cancer. * Patients affected by other solid tumors other than breast cancer. * Patients who have undergone antibiotic therapy within the 10 days prior to sample collection.
References
Publications (16)
- BACKGROUNDWhitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19. PMID 26092476
- BACKGROUNDLancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x. PMID 15189396
- BACKGROUNDMorasso C, Ricciardi A, Sproviero D, Truffi M, Albasini S, Piccotti F, Sottotetti F, Mollica L, Cereda C, Sorrentino L, Corsi F. Fast quantification of extracellular vesicles levels in early breast cancer patients by Single Molecule Detection Array (SiMoA). Breast Cancer Res Treat. 2022 Feb;192(1):65-74. doi: 10.1007/s10549-021-06474-3. Epub 2021 Dec 21. PMID 34935096
- BACKGROUNDBonizzi A, Signati L, Grimaldi M, Truffi M, Piccotti F, Gagliardi S, Dotti G, Mazzucchelli S, Albasini S, Cazzola R, Bhowmik D, Narayana C, Corsi F, Morasso C. Exploring breast cancer-related biochemical changes in circulating extracellular vesicles using Raman spectroscopy. Biosens Bioelectron. 2025 Jun 15;278:117287. doi: 10.1016/j.bios.2025.117287. Epub 2025 Feb 19. PMID 40023908
- BACKGROUNDYeat NY, Chen RH. Extracellular vesicles: biogenesis mechanism and impacts on tumor immune microenvironment. J Biomed Sci. 2025 Sep 4;32(1):85. doi: 10.1186/s12929-025-01182-2. PMID 40908470
- BACKGROUNDKonig L, Kasimir-Bauer S, Bittner AK, Hoffmann O, Wagner B, Santos Manvailer LF, Kimmig R, Horn PA, Rebmann V. Elevated levels of extracellular vesicles are associated with therapy failure and disease progression in breast cancer patients undergoing neoadjuvant chemotherapy. Oncoimmunology. 2017 Sep 27;7(1):e1376153. doi: 10.1080/2162402X.2017.1376153. eCollection 2017.