Assessing the role of microbiome in treating triple negative breast cancer
Prospective Evaluation of the Breast Microbiome and Tumor Microenvironment-related Biomarkers of Response to Neoadjuvant Systemic Therapy in Triple Negative Breast Cancer
This study is trying to see if the bacteria in the body can help doctors figure out the best treatments for people with early-stage triple negative breast cancer who are about to start chemotherapy and immune therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College Cork Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cork, Munster) |
| Trial ID | NCT06709651 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed triple negative breast cancer who are planning to undergo neoadjuvant systemic therapy.
Not a fit: Patients with breast cancer that is not triple negative or those who have already received treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with triple negative breast cancer.
How similar studies have performed: While the exploration of microbiome as a biomarker in oncology is a growing field, this specific approach in triple negative breast cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cork, Munster
- Cork University Hospital — Cork, Munster, Ireland (Recruiting)
Study contacts
- Study coordinator: Roisin Connolly
- Email: roisin.connolly@ucc.ie
- Phone: 021 4922687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.