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Clinical Trials in Italy / NCT07808086
Recruiting Observational

Role of Tumor Microbiota in the Response to Neoadjuvant Therapy in Patients Affected by Triple Negative Breast Cancer

NCT07808086 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Phase
Observational
Started
2026-09-01
Last updated
2026-09-23

Condition(s) studied

Breast Cancer

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Intratumoral microbiota characterization — From diagnostic biopsy (first time point) and at surgery (second time point).
    Measure of Staphylococcus spp. levels in tumor tissue
  • Tumor immune microenvironment characterization — From diagnostic biopsy (first time point) and at surgery (second time point).
    Measure of Treg and TAM in tumor tissue

Trial sites (1)

FacilityCityRegionStatus
Istituti Clinici Scientifici Maugeri Spa - Società Benefit IRCCS Pavia Italy Recruiting

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Different Localization Techniques for Non-palpable Breast Lesions Comparison: a Retrospective and Multicentric Clinical Study Active, not recruiting

Other trials for the same condition

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A) Active, not recruiting
The OPBC-07/microNAC Study Active, not recruiting
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Recruiting
Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study Active, not recruiting
Music Therapy in Patients With Breast Cancer (IMPACT) Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07808086 on ClinicalTrials.gov ↗ ← All trials in Italy