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NCT06318507 | RECRUITING | Breast Neoplasms

The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
Sponsor:

Pennington Biomedical Research Center

Information provided by (Responsible Party):

Justin Brown

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.

Condition or disease

Breast Neoplasms

Intervention/treatment

Fecal microbial diversity

Study Type : OBSERVATIONAL
Estimated Enrollment : 25 participants
Official Title : The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
Actual Study Start Date : 2024-03-11
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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 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
The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy

Location Details

NCT06318507

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How to Participate

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Locations

RECRUITING

United States, Louisiana

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808