Microbiome Immunotherapy Neoadjuvant Assessment

Inclusion Criteria

• •1. Be willing and able to provide written informed consent for the trial in accordance with national/local guidelines.
• •2. Be a male or female subject 18 years of age on day of signing informed consent.
• •3. 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.
• •4. 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
• •5. Be willing to undergo mandatory research biopsy procedure at baseline (up to 4 core samples may be taken from this procedure).