The Intestinal Microbiome in Triple Negative Breast Cancer Treated With Immunotherapy

Recruiting

• Conditions: Breast Neoplasms

• Registration Number: NCT06318507
• Lead Sponsor: Pennington Biomedical Research Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-11
• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic Complete Response (pCR)	Week 24	Defined as ypT0/Tis ypN0, ypT0 ypN0, and ypT0/Tis

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States