NCT06318507Recruiting
The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
Source: ClinicalTrials.gov · Last updated 17 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 25 (estimated)
- First submitted
- 11 Mar 2024
- Start date
- 11 Mar 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Pennington Biomedical Research Center
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06318507
What you commit to
- Study type: Observational
- Planned participants: 25
- From 11 Mar 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant conditions that require the use of antibiotics (e.g., chronic sinusitis)
Other illness
- Active autoimmune disease
- Digestive disease disorders (e.g., irritable bowel syndrome, Crohn's disease)
- 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
Other
- 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 situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pennington Biomedical Research Center Coordinator of this site? Confirm its status | Baton Rouge | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.