Recruiting

Pembrolizumab vs. Placebo

Sponsor:

Pennington Biomedical Research Center

Code:

NCT06318507

Conditions

Breast Neoplasms

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fecal microbial diversity

Study Details

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.

Conditions

Breast Neoplasms

Study ID

NCT06318507

Start date

Mar 11, 2024

Status verified date

Feb, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Interventions

Fecal microbial diversity

Fecal microbiome diversity via 16S rRNA and metagenomic sequencing

Primary outcome measure

  • Pathologic Complete Response (pCR) [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Justin Brown, Ph.D.

225-763-3000justin.brown@pbrc.edu

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Justin Brown, Ph.D.

225-763-2715justin.brown@pbrc.edu

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

Feb 17, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pennington Biomedical Research Center on 2025-02-17.