The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
Part of paid clinical trials in Baton Rouge, Louisiana.
- Sponsor
- Pennington Biomedical Research Center
- Study ID
- NCT06318507
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Fecal microbial diversity — COMBINATION_PRODUCTFecal microbiome diversity via 16S rRNA and metagenomic sequencing
Study Details
This study will determine how the intestinal microbiome differs between patients with obesity and early triple-negative breast cancer who achieve a pathologic complete response from preoperative anti-PD-1 immunotherapy (pembrolizumab) versus patients who do not.
Key Dates
- Start date
- Mar 11, 2024
- Status verified
- Feb 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 25 participants (estimated)
Primary Outcome Measure
Pathologic Complete Response (pCR) [ Time Frame: Week 24 ]
Central Contacts
- Justin Brown, Ph.D.225-763-3000
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 |
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