Pembrolizumab for Early Triple-Negative Breast Cancer

The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy

Recruiting Observational Study
Breast Neoplasms
No Study Drug Researchers observe your health over time — no experimental treatment is given.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
25 (estimated)
Sponsor
Pennington Biomedical Research Center · Other
Who this trial is looking for

This trial is looking for women who are newly diagnosed with early triple-negative breast cancer and are overweight or obese. Participants will receive a treatment called pembrolizumab before surgery and help researchers understand how gut bacteria may affect treatment response.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am 18 years old or older.
  • I am female.
  • I have early triple-negative breast cancer that has not been treated before.
  • I am about to start treatment with pembrolizumab.
  • I have a body mass index (BMI) of 25 or higher.
  • I can give written consent to participate.
  • I agree to allow the collection and storage of samples for future research.

You may not be able to join if

  • I have an active autoimmune disease.
  • I have a condition that requires antibiotics.
  • I have a digestive disorder like irritable bowel syndrome.
  • I am currently pregnant, breastfeeding, or planning to become pregnant soon.
  • I have taken glucocorticoids for more than 10 days in the last 90 days.
  • I have any other serious health condition that would make it hard for me to participate.
  • I am in a situation that would negatively affect my safety or ability to follow the study rules.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial

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.

Trial Locations
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Eligibility Criteria
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 k…
Contacts

Justin Brown, Ph.D.

225-763-3000

justin.brown@pbrc.edu

CONTACT