The Intestinal Microbiome in Triple Negative Breast Cancer Treated With Immunotherapy

Breast Neoplasms Clinical Trial

— IMPACT  

Official title:

The Intestinal Microbiome in Triple Negative Breast Cancer Treated With Immunotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318507
• Other study ID #: PBRC 2023-014
• Status: Recruiting
• Start date: March 11, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Pennington Biomedical Research Center
• Contact: Justin Brown, Ph.D.
• Phone: 225-763-3000
• Email: justin.brown[@]pbrc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic Complete Response (pCR)	Defined as ypT0/Tis ypN0, ypT0 ypN0, and ypT0/Tis	Week 24