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RecruitingNCT06318507IMPACTUpdated Feb 17, 2025

The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy

An observational study in Breast Neoplasms, sponsored by Pennington Biomedical Research Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-17.

Sponsored by Pennington Biomedical Research Center · Observational

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Neoplasms

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03

In context

Breast Neoplasms

12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 25 is below the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Pennington Biomedical Research Center is the lead sponsor of 284 studies on the registry; 31 are open to participants now.

Browse Pennington Biomedical Research Center studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will consist of survivors of early triple-negative breast cancer.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No

Interventions

  • Combination productFecal microbial diversity

    Fecal microbiome diversity via 16S rRNA and metagenomic sequencing

06

What researchers measure

Primary outcomes

  1. Pathologic Complete Response (pCR)

    Defined as ypT0/Tis ypN0, ypT0 ypN0, and ypT0/Tis

    Time frame: Week 24

07

Study locations

1 of 1 sites recruiting
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70808, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Dec 2026, 33 months after the start.

Of 1,012 non-industry observational studies under Breast Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 141. This study's planned 33 months is below that.

Counting every sponsor, half of 1,165 studies reached it within 58 months; a quarter within 26 and three quarters within 125.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2024
First posted
Mar 19, 2024
StartActual
Mar 11, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Feb 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06318507
Lead sponsor
Pennington Biomedical Research Center
Responsible party
Justin Brown (Associate Professor, Pennington Biomedical Research Center) — Principal investigator
First posted
Mar 19, 2024
Start date
Mar 11, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 17, 2025

Study contacts

Justin Brown, Ph.D.
Contact
justin.brown@pbrc.edu
225-763-3000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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