Actively Recruiting

Age: 18Years +
FEMALE
NCT05030038

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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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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