Microbiome Immunotherapy Neoadjuvant Assessment (MINA)

Prospective Evaluation of the Breast Microbiome and Tumor Microenvironment-related Biomarkers of Response to Neoadjuvant Systemic Therapy in Triple Negative Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Triple Negative Breast Cancer

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Roisin Connolly; Phone Number: 021 4922687; Email: roisin.connolly@ucc.ie

Study Locations

• Ireland
  • Munster
    • Cork, Munster, Ireland
      • Recruiting
      • Cork University Hospital
      • Contact: Roisin Connolly; Phone Number: 0214922687

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in Cork University Hospital that meet inclusion criteria

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	Correlation between breast microbiome composition (measured as percent abundance of microbial taxa derived from metagenomic sequencing) and event free survival (EFS)	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	Correlation between breast microbiome composition (measured as percent abundance of microbial taxa derived from metagenomic sequencing) and overall survival (OS)	Through study completion, an average of 1 year
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%)	Through study completion, an average of 1 year
To determine the relationship between the breast cancer microbiome and programmed death ligand -1 (PDL-1)	Correlation between breast microbiome composition (measured as percent abundance of microbial taxa derived from metagenomic sequencing) and , PDL1 (positive defined as CPS ≥ 1 by PD-L1 IHC 22C3 assay versus negative)	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	Change in the gut microbiome composition (measured as percent abundance of microbial taxa derived from metagenomic sequencing) between pre- and post-therapy	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University College Cork
• Collaborators: Breast Cancer Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Skin and Connective Tissue Diseases; Triple Negative Breast Neoplasms
• Other Study ID Numbers: 23120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No