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

NCT07808086 | Recruiting

• 1 other identifier: CTSPV104-26
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Intratumoral microbiota; Neoadjuvant therapy; Predictive biomarkers; Immunosuppression; Fecal microbiota; Tumor Immune Microenvironment; Extracellular vesicles; Triple negative breast cancer

Outcome Measures

Primary Outcomes (2)

• Intratumoral microbiota characterization

  Measure of Staphylococcus spp. levels in tumor tissue

  From diagnostic biopsy (first time point) and at surgery (second time point).

• Tumor immune microenvironment characterization

  Measure of Treg and TAM in tumor tissue

  From diagnostic biopsy (first time point) and at surgery (second time point).

Secondary Outcomes (2)

• Extracellular vescicles analysis

  From diagnostic biopsy (first time point) and at surgery (second time point).

• Correlation between intratumor and fecal microbiota profiles

  Prior to neoadjuvant chemotherapy and at surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients referred to the Breast Unit of IRCCS ICS Maugeri of Pavia and the Istituto Nazionale dei Tumori of Milan, diagnosed with triple-negative breast cancer and scheduled for neoadjuvant treatment followed by surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: collaborator

Study Sites (1)

Istituti Clinici Scientifici Maugeri Spa - Società Benefit IRCCS

Pavia, 27100, Italy

RECRUITING

Related Publications (16)

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Biospecimen

Retention: SAMPLES WITH DNA

tumoral tissue, whole blood samples, fecal samples

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fabio Corsi, Prof.

  ICS Maugeri SpA-SB - IRCCS Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Fabio Corsi

CONTACT

+39 0382592272; fabio.corsi@icsmaugeri.it

Dott.ssa Marta Truffi, PhD

CONTACT

+390382592272; marta.truffi@icsmaugeri.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 8, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 13, 2029
• Study Completion (Estimated): August 13, 2029
• Last Updated: September 23, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)