RecruitingNCT06318507

The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy

Sponsor

Pennington Biomedical Research Center

Enrollment

25 participants

Start Date

Mar 11, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Neoplasms

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

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 Criteria7

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