The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy (IMPACT)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasms
• Intervention / Treatment: Combination product: Fecal microbial diversity

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Justin Brown, Ph.D.; Phone Number: 225-763-3000; Email: justin.brown@pbrc.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Pennington Biomedical Research Center
      • Contact: Justin Brown, Ph.D.; Phone Number: 225-763-2715; Email: justin.brown@pbrc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic Complete Response (pCR)	Defined as ypT0/Tis ypN0, ypT0 ypN0, and ypT0/Tis	Week 24

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: PBRC 2023-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No