NCT06318507 The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
| NCT ID | NCT06318507 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pennington Biomedical Research Center |
| Condition | Breast Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-03-11 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2024-03-11 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06318507 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06318507 currently recruiting?
Yes, NCT06318507 is actively recruiting participants. Contact the research team at justin.brown@pbrc.edu for enrollment information.
Where is the NCT06318507 trial being conducted?
This trial is being conducted at Baton Rouge, United States.
Who is sponsoring the NCT06318507 clinical trial?
NCT06318507 is sponsored by Pennington Biomedical Research Center. The trial plans to enroll 25 participants.