Microbiome Immunotherapy Neoadjuvant Assessment
ConditionTriple Negative Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity College Cork
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Be willing and able to provide written informed consent for the trial in accordance with national/local guidelines.
Be a male or female subject 18 years of age on day of signing informed consent.
Be willing to undergo mandatory research biopsy procedure at baseline (up to 4 core samples may be taken from this procedure).
Disqualifiers
Patients who are pregnant or breast-feeding
Current use of any investigational agents
History or current evidence of any condition, therapy, lab abnormality or other circumstance that in the opinion of the investigator might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial.
Trial population
Patients in Cork University Hospital that meet inclusion criteria
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
To evaluate the breast cancer microbiome pre- and post-therapy, in patients with early stage TNBC undergoing neoadjuvant systemic therapy
Microbiome evaluation with metagenomic sequencing to assess changes in the relative abundance of microbial taxa (measured as percentage abundance per microbial species and changes in percentage abundance between baseline and post-therapy timepoints)
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and pathologic complete response
Correlation between breast microbiome composition (measured as percent abundance of microbial taxa derived from metagenomic sequencing) and pathologic complete response rate (pCR)
Time frame
Through study completion, an average of 1 year2
To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and event-free survival
Correlation between breast microbiome composition (measured as percent abundance of microbial taxa derived from metagenomic sequencing) and event free survival (EFS)
Time frame
Through study completion, an average of 1 year3
To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and overall survival
Correlation between breast microbiome composition (measured as percent abundance of microbial taxa derived from metagenomic sequencing) and overall survival (OS)
Time frame
Through study completion, an average of 1 year4
To determine the relationship between the breast cancer microbiome and tumor infiltrating leukocytes (TILs)
Correlation between breast microbiome composition (measured as percent abundance of microbial taxa derived from metagenomic sequencing) and TILS (\<50% versus ≥50%)
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University College Cork
Lead sponsor
Breast Cancer Research Foundation
Collaborator
Source ClinicalTrials.gov