Actively Recruiting
Microbiome Immunotherapy Neoadjuvant Assessment
Led by University College Cork · Updated on 2026-03-04
30
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
U
University College Cork
Lead Sponsor
B
Breast Cancer Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Microbiome Immunotherapy Neoadjuvant Assessment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Male or female aged 18 years or older at the time of informed consent
- Histologically confirmed infiltrating breast carcinoma with HER2-negative status by ASCO/CAP guidelines
- Estrogen receptor and progesterone receptor negative tumor with less than 10% expression by immunohistochemistry
- Untreated, unresected breast cancer planned for neoadjuvant systemic therapy with T2, T3, or T4a-d lesion, any N, M0 stage
- Willing to undergo mandatory research biopsy at baseline with up to 4 core samples taken
You will not qualify if you...
- Pregnant or breastfeeding patients
- Current use of any investigational agents
- Any condition, therapy, lab abnormality, or circumstance that may increase risk or interfere with participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cork University Hospital
Cork, Munster, Ireland
Actively Recruiting
Research Team
R
Roisin Connolly
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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