CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled / 24 target
Drug / intervention
Fecal swab collection +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05030038
NCT05030038N/ACompletedOn Track (0.5/mo)Completion was 11mo ago

Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability

Wake Forest University Health Sciences·observational·Posted Sep 1, 2021·Updated Jun 15, 2026

In Brief

An observational study evaluating Fecal swab collection and Blood samples for Breast Cancer. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedSep 1, 2021
Enrollment StartMar 29, 2022
Primary CompletionJul 28, 2025
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 4.8 years ago

Arms & Interventions

Aromatase inhibitor for breast cancer treatmentother

Participants will receive their standard of care for breast cancer treatment which includes an aromatase inhibitor. Pre-study assessments will be done at baseline as well as stool and blood samples at baseline, then again at 4 weeks and at 12 weeks during the course of the trial.

Biological: Fecal swab collectionBiological: Blood samples

Interventions

Fecal swab collectionbiological

Participants will collect fecal sample at home and either mail in the sample, or drop it off at the lab

Blood samplesbiological

Participants will have approximately 1 teaspoon of blood withdrawn from a vein, for research, on 2 different occasions. The total amount of blood withdrawn during the study will be approximately 2 teaspoons.