Microbiome Immunotherapy Neoadjuvant Assessment

Launched by UNIVERSITY COLLEGE CORK · Nov 27, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Microbiome Immunotherapy Neoadjuvant Assessment," is studying how certain bacteria in breast tumors might affect the response to treatments for triple-negative breast cancer (TNBC). Researchers believe that understanding the specific microbes present in a patient’s tumor could help doctors personalize treatment plans, potentially improving the effectiveness of combination chemotherapy and immune therapies. The trial is currently seeking participants who have been diagnosed with early-stage TNBC and who are planning to start treatment.

To be eligible, participants must be at least 18 years old and have a specific type of breast cancer that is HER2 negative and hormone receptor negative. They should also be willing to undergo a research biopsy, which involves taking small samples of their tumor tissue for analysis. Patients who are pregnant, breastfeeding, or currently using other experimental treatments cannot participate. Those who join the trial will help explore new ways to better tailor cancer treatments based on the bacteria present in their tumors, which could lead to more effective care for future patients with TNBC.

Gender

ALL

Eligibility criteria

• 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).
• Exclusion Criteria:
• • 1. Patients who are pregnant or breast-feeding
• • 2. Current use of any investigational agents
• • 3. 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.