Microbiome Immunotherapy Neoadjuvant Assessment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Triple Negative Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Evaluation of the Breast Microbiome and Tumor Microenvironment-related Biomarkers of Response to Neoadjuvant Systemic Therapy in Triple Negative Breast Cancer
Overview
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.
Primary outcome measures
- To evaluate the breast cancer microbiome pre- and post-therapy, in patients with early stage TNBC undergoing neoadjuvant systemic therapy [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (6)
- To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and pathologic complete response [Time frame: Through study completion, an average of 1 year]
- To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and event-free survival [Time frame: Through study completion, an average of 1 year]
- To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and overall survival [Time frame: Through study completion, an average of 1 year]
- To determine the relationship between the breast cancer microbiome and tumor infiltrating leukocytes (TILs) [Time frame: Through study completion, an average of 1 year]
- To determine the relationship between the breast cancer microbiome and programmed death ligand -1 (PDL-1) [Time frame: Through study completion, an average of 1 year]
- To evaluate the gut microbiome pre- and post-therapy, in patients with early stage TNBC undergoing neoadjuvant systemic therapy [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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.
- Histologically proven infiltrating carcinoma of the breast on core needle biopsy that is:
HER2 negative in primary tumour pre-treatment by local pathology assessed according current ASCO/CAP guidelines: In situ hybridization non-amplified (ratio of HER2 to CEP17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell), OR Immunohistochemistry (IHC) 0 or IHC 1+.
ER and PR negative in primary tumour pre-treatment defined as < 10% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment.
- Unresected, untreated breast cancer planned to undergo neoadjuvant systemic therapy, that meets one of the following clinical stages (see Appendix A):
o T2, T3, or T4a-d lesion, any N, M0
- Be willing to undergo mandatory research biopsy procedure at baseline (up to 4 core samples may be taken from this procedure).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Ireland · 1 center
- Cork University Hospital — Cork
Identifiers
NCT: NCT06709651 · 23120