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
- Breast Cancer
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Enrolment target
- 30
- Started
- 1 September 2026
- Main results due
- 13 August 2029
- Study sites
- 1
- Registry updated
- 23 September 2026
Can you take part?
- Aged 18 years and over.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Istituti Clinici Scientifici Maugeri Spa - Società Benefit IRCCS
Pavia, Italy
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07808086. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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