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Recruiting NCT06318507

The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy

— Observational Breast Neoplasms

For patients and families

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fecal microbial diversity.
Who it may be relevant to
Registry conditions: Breast Neoplasms. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Combination product Fecal microbial diversity
    Fecal microbiome diversity via 16S rRNA and metagenomic sequencing

Primary outcome measures

  • Pathologic Complete Response (pCR) [Time frame: Week 24]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Pennington Biomedical Research Center — Baton Rouge

Identifiers

NCT: NCT06318507 · PBRC 2023-014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗