Assessing the role of microbiome in treating triple negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify predictive biomarkers related to the microbiome in patients with early-stage triple negative breast cancer (TNBC) who are set to receive neoadjuvant chemotherapy and immune-checkpoint inhibitors. By analyzing the tumor-associated microbiota in breast tumors, the study seeks to understand how these microbes may influence the effectiveness of standard cancer therapies. The goal is to explore the potential of microbiome profiles as novel biomarkers that could help tailor treatment strategies for TNBC patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cork University Hospital
  Cork, Munster, Ireland Recruiting

Study contacts

• Study coordinator: Roisin Connolly
• Email: roisin.connolly@ucc.ie
• Phone: 021 4922687

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Oral paclitaxel in triple-negative breast cancer before main chemotherapy

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  Recruiting Phase 1/2 The Affiliated Hospital Of Guizhou Medical University · Guiyang, Guizhou · NCT07739485

• Granzyme B-PET to see if immunotherapy works in TNBC

  This study will test whether a Granzyme B PET/CT scan can help predict how well immunotherapy will work for adults with locally advanced or metastatic triple-negative breast cancer receiving an immune checkpoint inhibitor.

  Recruiting Fudan University · Shanghai · NCT07705438

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.