Role of tumor microbiota in modulating response to neoadjuvant therapy in TNBC
Official title: Study of the Role of the Tumor Microbiota in the Neoadjuvant Therapy Response on Triple Negative Breast Cancer Patients
Run by Istituti Clinici Scientifici Maugeri SpA · NCT07808086 · Data updated 2026-11-12
This study tests whether microbes in tumor tissue and the gut help predict how well patients with triple-negative breast cancer respond to neoadjuvant chemotherapy and immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, trastuzumab |
| Locations | 1 site (Pavia) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | August 13, 2029 |
| Study ends | August 13, 2029 |
| Registry record updated | September 23, 2026 |
| Trial ID | NCT07808086 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult women with triple-negative breast cancer indicated for neoadjuvant chemotherapy or chemo-immunotherapy who consent to participation.
✕Probably not a fit
Patients with different biology or those not fitting the biomarker profile may not see benefit from the overlying predictive insights.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study explores how intratumoral and intestinal microbiota, along with the tumor immune microenvironment, relate to treatment response in TNBC patients receiving neoadjuvant therapy. Researchers will examine microbiota composition and immune markers to identify potential predictive factors for achieving pathological complete response. The study builds on existing evidence that microbiota can influence immune activity and cancer treatment efficacy. No interventional treatment is assigned by the study; data are collected during standard care and follow-up. The goal is to improve patient stratification and guide future biomarker-driven approaches.
Why it matters
Potential benefit: If successful, the findings could help tailor neoadjuvant therapy by identifying patients more likely to benefit based on microbiota and immune profiles.
How similar studies have gone: Similar approaches in other cancers have linked microbiota to treatment response, but results are heterogeneous and this TNBC-specific investigation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Istituti Clinici Scientifici Maugeri Spa - Società Benefit IRCCS
Pavia, Italy Recruiting
Study contacts
- Principal investigator: Fabio Corsi, Prof. — ICS Maugeri SpA-SB - IRCCS Pavia
- Study coordinator: Prof. Fabio Corsi
- Email: fabio.corsi@icsmaugeri.it
- Phone: +39 0382592272
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.