The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
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(s) | Breast Neoplasms |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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. |
| Who can participate | 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 c |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Pennington Biomedical Research Center |
| Locations | Baton Rouge, Louisiana, United States |
| Start date | 2024-03-11 |
| NCT ID | NCT06318507 |
| Official listing | https://clinicaltrials.gov/study/NCT06318507 |