The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy

NCT06318507 | Recruiting

• 1 other identifier: PBRC 2023-014
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (pCR)

  Defined as ypT0/Tis ypN0, ypT0 ypN0, and ypT0/Tis

  Week 24

Interventions

Fecal microbial diversity COMBINATION_PRODUCT

Fecal microbiome diversity via 16S rRNA and metagenomic sequencing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of survivors of early triple-negative breast cancer.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Justin Brown, Ph.D.

CONTACT

225-763-3000; justin.brown@pbrc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 19, 2024
• Study Start: March 11, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)