OncoMatch/Clinical Trials/NCT07808086
Role of Tumor Microbiota in the Response to Neoadjuvant Therapy in Patients Affected by Triple Negative Breast Cancer
Official title: Study of the Role of the Tumor Microbiota in the Neoadjuvant Therapy Response on Triple Negative Breast Cancer Patients
Is NCT07808086 recruiting? Yes, currently enrolling (Oct 2026).
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) wild-type
Required: ESR1 wild-type
Required: PR (PGR) wild-type
Demographics
Prior therapy
Cannot have received: chemotherapy
Patients that have already been treated with chemotherapy.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07808086 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 wild-type is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR wild-type is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages