Actively Recruiting
The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
Led by Pennington Biomedical Research Center · Updated on 2025-02-17
25
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63;18 years
- Biological female sex
- Newly diagnosed, previously untreated, histologically confirmed early triple-negative breast cancer
- Plan to start preoperative anti-PD-1 immunotherapy with pembrolizumab
- Overweight or obesity with body mass index 63;25 kg/m2
- Ability to provide written informed consent
- Agree to collection and storage of biospecimens and data for future research
You will not qualify if you...
- Active autoimmune disease
- Conditions requiring antibiotics use, such as chronic sinusitis
- Digestive disorders like irritable bowel syndrome or Crohn's disease
- Currently pregnant, breastfeeding, or planning pregnancy within 24 weeks
- Use of glucocorticoids for more than 10 consecutive days within the past 90 days
- Cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other conditions that may prevent participation or compliance
- Any other situation deemed by the investigator to affect safety or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
Research Team
J
Justin Brown, Ph.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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