|

Oral Aromatase Inhibitors Modify the Gut Microbiome

RECRUITINGSponsored by Wake Forest University Health Sciences
Actively Recruiting
SponsorWake Forest University Health Sciences
Started2022-03-29
Est. completion2026-04
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* Pathologic diagnosis in situ or invasive breast cancer for which initiating aromatase inhibitors therapy is recommended or initiating aromatase inhibitors for risk reduction.
* ECOG performance status 0,1, 2, 3.
* Age ≥ 18 years
* HER2+ breast cancer is allowed if patients are on a monoclonal antibody therapy for which a change is not anticipated while on study (12 weeks) and they have been on the monoclonal antibody therapy for at least 4 weeks.
* Ability to read, understand and evaluate study materials and willingness to sign a written informed consent document.

Exclusion Criteria:

* Have been on antibiotics within 4 weeks of enrollment.
* Administered chemotherapy less than 4 weeks prior to enrollment.
* Hormone replacement (defined as only estrogen and/or progesterone replacement) or anti-estrogen therapy within 4 weeks of starting aromatase inhibitors
* Use of antibody drug conjugate (HER2+ breast cancer)
* Male breast cancer
* Any serious and/or unstable pre-existing medical, psychiatric, or other existing condition that would prevent compliance with the trial or consent process

Conditions2

Breast CancerCancer

Locations1 site

Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, 27157
Study Coordinator336-713-5435jriley@wakehealth.edu

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.