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Observational Study: Gut Microbiome and Immunotherapy for Triple-Negative Breast Cancer

This study is looking at how the bacteria in your gut (intestinal microbiome) might affect how well immunotherapy works for triple-negative breast cancer. Researchers want to see if there are differences in the gut bacteria of patients who respond well to pembrolizumab (an anti-PD-1 immunotherapy) compared to those who don't. You may be able to join if you are a woman, 18 or older, newly diagnosed with early triple-negative breast cancer, plan to start pembrolizumab, and are overweight or have obesity. The study will measure how many cancer cells are left after treatment (pathologic complete response) at 24 weeks. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will be looking at existing information rather than testing a new treatment. It plans to include 25 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at Week 24.

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NCT06318507

The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy

Recruiting
Not specifiedAges 18+Observational
Pennington Biomedical Research Center
~25 participants
Updated 2025-02-17 on ClinicalTrials.gov
What's tested:Fecal microbial diversity

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathologic Complete Response (pCR)
Measured over Week 24

Conditions

Breast Neoplasms

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Louisiana1

Who to contact

Justin Brown, Ph.D.
[email protected]
225-763-3000
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Pathologic Complete Response (pCR)Week 24

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