RECRUITING

The Intestinal Microbiome in Triple Negative Breast Cancer Treated With Immunotherapy

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Conditions

Breast Neoplasms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Intestinal Microbiome in Triple Negative Breast Cancer Treated With Immunotherapy

Quick Facts

Study Start:2024-03-11
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06318507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years
  2. * Female biological sex
  3. * Newly diagnosed, previously untreated, histologically confirmed early triple-negative breast cancer
  4. * Plan to initiate preoperative anti-PD-1 immunotherapy using pembrolizumab
  5. * Overweight or obesity, defined as a body mass index \>=25 kg/m2
  6. * Ability to provide written informed consent
  7. * Allow the collection and storage of biospecimens and data for future use
  1. * Active autoimmune disease
  2. * Concomitant conditions that require the use of antibiotics (e.g., chronic sinusitis)
  3. * Digestive disease disorders (e.g., irritable bowel syndrome, Crohn's disease)
  4. * Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks
  5. * Recent (within 90 days) use of glucocorticoids for more than 10 consecutive days
  6. * 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
  7. * Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
United States

Collaborators and Investigators

Sponsor: Pennington Biomedical Research Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-11
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-03-11
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Neoplasms