Oral Aromatase Inhibitors Modify the Gut Microbiome

Recruiting

• Conditions: Breast Cancer
• Interventions: Biological: Fecal swab collection; Biological: Blood samples

• Registration Number: NCT05030038
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed Description

Primary Objective: To describe the microbiome shift of gut microbiome from baseline after 4-weeks and 12-weeks of oral aromatase inhibitor treatment.

Secondary Objective

* To correlate gut microbiome populations with circulating sex hormone metabolite concentrations at baseline and 12 weeks.

* To describe the correlation of change in the microbiome populations with change in circulating sex hormone metabolite concentrations from baseline to 12 weeks.

Study Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-09-01
• Study Start: 2022-03-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aromatase inhibitor for breast cancer treatment	Fecal swab collection	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.
Aromatase inhibitor for breast cancer treatment	Blood samples	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.

Primary Outcome Measures

Name	Time	Method
Change in Gut Microbial Levels - Fecal Swab	At baseline, 4 weeks and 12 weeks	To describe the microbiome shift of gut microbiome from baseline after 4-weeks and 12-weeks of oral aromatase inhibitor treatment Investigators will calculate the change in gut microbial levels using paired t-tests.

Secondary Outcome Measures

Name	Time	Method
Change in Sex Hormone Concentrations - Blood Samples	At baseline and at 12 weeks	Investigators will fit a model with independent variables of the value (baseline or 12 weeks), and a second variable that represents the change from baseline (will be 0 or the change at 12 weeks).; Estrone, estrone-3-glucuronide, and estrone-3-sulfate concentrations will be measured using an ELISA assay conducted on plasma.
Change in Gut Microbial Levels - Blood Samples	At baseline and at 12 weeks	Investigators will calculate Pearson or Spearman correlation coefficients between diversity and gut microbial levels and circulating sex hormone metabolite concentrations at baseline and at 12 weeks. Bacterial derived bioactive compounds, bile acids, and glucuronidated sex hormones will be compared by metabolomics conducted on plasma.

Trial Locations

Locations (1)

Wake Forest Baptist Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States