Overview
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.
Eligibility
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