Actively Recruiting

Age: 18Years +
FEMALE
NCT06318507

The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy

Led by Pennington Biomedical Research Center · Updated on 2025-02-17

25

Participants Needed

1

Research Sites

146 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 63;18 years
  • Biological female sex
  • Newly diagnosed, previously untreated, histologically confirmed early triple-negative breast cancer
  • Plan to start preoperative anti-PD-1 immunotherapy with pembrolizumab
  • Overweight or obesity with body mass index 63;25 kg/m2
  • Ability to provide written informed consent
  • Agree to collection and storage of biospecimens and data for future research
Not Eligible

You will not qualify if you...

  • Active autoimmune disease
  • Conditions requiring antibiotics use, such as chronic sinusitis
  • Digestive disorders like irritable bowel syndrome or Crohn's disease
  • Currently pregnant, breastfeeding, or planning pregnancy within 24 weeks
  • Use of glucocorticoids for more than 10 consecutive days within the past 90 days
  • Cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other conditions that may prevent participation or compliance
  • Any other situation deemed by the investigator to affect safety or study compliance

AI-Screening

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Trial Site Locations

Total: 1 location

1

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808

Actively Recruiting

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Research Team

J

Justin Brown, Ph.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy | DecenTrialz