Examining the gut microbiome in women with early triple-negative breast cancer receiving immunotherapy
Official title: The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
Run by Pennington Biomedical Research Center · NCT06318507 · Data updated 2026-11-12
This study is testing how the gut bacteria of overweight or obese women with early triple-negative breast cancer affects their response to a specific immunotherapy treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 25 (estimated) |
| Sponsor | Pennington Biomedical Research Center Academic / other |
| Drugs / interventions | pembrolizumab, immunotherapy |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Status | Recruiting |
| Started | March 11, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 17, 2025 |
| Trial ID | NCT06318507 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with newly diagnosed, untreated early triple-negative breast cancer who are overweight or obese.
✕Probably not a fit
Patients with active autoimmune diseases, digestive disorders, or those currently pregnant or breastfeeding may not benefit from this study.
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 investigate the differences in the intestinal microbiome between overweight or obese women with early triple-negative breast cancer who respond to preoperative anti-PD-1 immunotherapy (pembrolizumab) and those who do not. By analyzing fecal microbial diversity, the study seeks to identify potential biomarkers that could predict treatment outcomes. Participants must be newly diagnosed and histologically confirmed to have early-stage triple-negative breast cancer and plan to start immunotherapy. The study will also collect and store biospecimens for future research.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies based on microbiome profiles, improving outcomes for patients with triple-negative breast cancer.
How similar studies have gone: While the role of the microbiome in cancer treatment is an emerging field, this specific approach has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Female biological sex * Newly diagnosed, previously untreated, histologically confirmed early triple-negative breast cancer * Plan to initiate preoperative anti-PD-1 immunotherapy using pembrolizumab * Overweight or obesity, defined as a body mass index \>=25 kg/m2 * Ability to provide written informed consent * Allow the collection and storage of biospecimens and data for future use Exclusion Criteria: * Active autoimmune disease * Concomitant conditions that require the use of antibiotics (e.g., chronic sinusitis) * Digestive disease disorders (e.g., irritable bowel syndrome, Crohn's disease) * Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks * Recent (within 90 days) use of glucocorticoids for more than 10 consecutive days * Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol * Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol
Where it's running
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Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States Recruiting
Study contacts
- Study coordinator: Justin Brown, Ph.D.
- Email: justin.brown@pbrc.edu
- Phone: 225-763-3000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.