Role of Tumor Microbiota in the Response to Neoadjuvant Therapy in Patients Affected by Triple Negative Breast Cancer
Key facts
- Where
- Pavia, ItalySee the site
Where in Italy
- Istituti Clinici Scientifici Maugeri Spa - Società Benefit IRCCSPavia, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Istituti Clinici Scientifici Maugeri SpA
- Trial code
- NCT07808086
- Record updated
- 23 September 2026
- Original description
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.Read full original descriptionShow less
Study of the Role of the Tumor Microbiota in the Neoadjuvant Therapy Response on Triple Negative Breast Cancer Patients
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.
Inclusion: 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: Patients that have already been treated with chemotherapy; Patients who have undergone antibiotic therapy within the 10 days prior to sample collection; Patients that did not receive an official cyto-histological diagnosis of breast cancer; Patients affected by other solid tumors other than breast cancer; If a subject meets any of the following criteria, they must be excluded from the study.