Actively Recruiting
Oral Aromatase Inhibitors Modify the Gut Microbiome
Led by Wake Forest University Health Sciences · Updated on 2026-04-13
25
Participants Needed
1
Research Sites
222 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this research is to study the bacteria in participants' gut before receiving a medicine called an aromatase inhibitor for breast cancer and after participants receive medicine for breast cancer.
CONDITIONS
Official Title
Oral Aromatase Inhibitors Modify the Gut Microbiome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologic diagnosis of in situ or invasive breast cancer recommended for aromatase inhibitor therapy or risk reduction
- ECOG performance status 0, 1, 2, or 3
- Age 18 years or older
- HER2+ breast cancer patients on stable monoclonal antibody therapy for at least 4 weeks with no anticipated changes during the 12-week study
- Ability to read, understand, and evaluate study materials and willingness to sign informed consent
You will not qualify if you...
- Use of antibiotics within 4 weeks before enrollment
- Chemotherapy administered less than 4 weeks before enrollment
- Hormone replacement therapy (only estrogen and/or progesterone) or anti-estrogen therapy within 4 weeks before starting aromatase inhibitors
- Use of antibody drug conjugate therapy for HER2+ breast cancer
- Male breast cancer
- Any serious or unstable medical, psychiatric, or other condition preventing compliance with the study or consent process
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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