Recruiting
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.
ClinicalTrials.gov IDNCT06318507
PhaseNot Applicable
Enrollment25
SponsorPennington Biomedical Research Center
Age18 Years
SexFEMALE
Conditions studied
Breast Neoplasms
About this study
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.
Interventions
- Combination Product: Fecal microbial diversity — Fecal microbiome diversity via 16S rRNA and metagenomic sequencing
Primary outcomes
- Pathologic Complete Response (pCR) (Week 24)
Eligibility information
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 locations
- Pennington Biomedical Research Center, Baton Rouge, Louisiana 70808 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.