RecruitingNCT06709651

Microbiome Immunotherapy Neoadjuvant Assessment

Prospective Evaluation of the Breast Microbiome and Tumor Microenvironment-related Biomarkers of Response to Neoadjuvant Systemic Therapy in Triple Negative Breast Cancer

Sponsor

University College Cork

Enrollment

30 participants

Start Date

Oct 2, 2024

Study Type

OBSERVATIONAL

Conditions

Triple-Negative Breast Cancer

Summary

Predictive biomarkers of response to combination chemotherapy and immune-checkpoint inhibitors are urgently needed to help tailor treatment recommendations for patients with early-stage TNBC. Tumour-associated microbiota in primary breast tumours represent promising and novel candidate biomarkers modulators of the efficacy of therapies for patients with TNBC. It has been shown that microbes colonizing breast tumours can modulate the efficacy of commonly used drugs and that the microbiome of breast tissue biopsies could represent a new biomarker. Data on the microbiome of patients with cancer indicate the potential for a new class of bacteria-based oncological biomarkers, for exploitation in precision oncology.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how the gut microbiome (the bacteria living in your digestive system) affects how well immunotherapy works before surgery for breast cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with triple-negative breast cancer (the tumor does not respond to HER2, estrogen, or progesterone) - Your breast cancer has not yet been treated or surgically removed - Your tumor is at least a certain size (T2 or larger), has no distant spread - You are willing to have a tumor biopsy at the start of the study **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are currently taking part in another experimental drug study - You have a health condition the doctor thinks would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Cork University Hospital

Cork, Munster, Ireland

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NCT06709651

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