The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
Purpose
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.
Condition
- Breast Neoplasms
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Recruiting Locations
Pennington Biomedical Research Center
Baton Rouge, Louisiana 70808
Baton Rouge, Louisiana 70808
More Details
- NCT ID
- NCT06318507
- Status
- Recruiting
- Sponsor
- Pennington Biomedical Research Center