Microbiome Immunotherapy Neoadjuvant Assessment

NCT06709651 | Recruiting

• 1 other identifier: 23120
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Triple Negative Breast Cancer

Outcome Measures

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)

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and pathologic complete response

  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

  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

  Through study completion, an average of 1 year

• To determine the relationship between the breast cancer microbiome and tumor infiltrating leukocytes (TILs)

  Through study completion, an average of 1 year

• To determine the relationship between the breast cancer microbiome and programmed death ligand -1 (PDL-1)

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in Cork University Hospital that meet inclusion criteria

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Cork: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

Cork University Hospital

Cork, Munster, Ireland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Breast tissue biopsy, blood and stool samples will be collected

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Roisin Connolly

CONTACT

021 4922687; roisin.connolly@ucc.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 29, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

IE (1)