Oral Aromatase Inhibitors Modify the Gut Microbiome

NCT05030038 | Completed DMC

• 3 other identifiers: IRB00076577WFBCCC 74121P30CA012197
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Gut microbiome; Circulating sex hormone metabolite concentrations

Outcome Measures

Primary Outcomes (1)

• Change in Gut Microbial Levels - Fecal Swab

  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.

  At baseline, 4 weeks and 12 weeks

Secondary Outcomes (2)

• Change in Gut Microbial Levels - Blood Samples

  At baseline and at 12 weeks

• Change in Sex Hormone Concentrations - Blood Samples

  At baseline and at 12 weeks

Study Arms (1)

Aromatase inhibitor for breast cancer treatment

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 collection; Biological: Blood samples

Interventions

Blood samples BIOLOGICAL

Participants will have approximately 1 teaspoon of blood withdrawn from a vein, for research, on 2 different occasions. The total amount of blood withdrawn during the study will be approximately 2 teaspoons.

Aromatase inhibitor for breast cancer treatment

Fecal swab collection BIOLOGICAL

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

Aromatase inhibitor for breast cancer treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women of all races and ethnicity who meet the eligibility criteria are eligible for this trial.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

* cPlasma will be divided into 250 mL aliquots and stored at -80 freezer in Cook Lab at BioTech Place. Blood metabolomics will be performed to identify microbial mediated metabolites using a non-targeted LC-MS/MS approach. Plasma will also be used to measure estradiol, estrone, and estrone-3-glucuronide by ELISA. * Fecal Samples will be mailed directly to CosmosID for DNA isolation and 12M read depth metagenomics sequencing.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Katherine Ansley, MD

  Wake Forest Baptist Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 1, 2021
• Study Start: March 29, 2022
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)