Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

All Drugs and Chemicals

Hormones

Estrogens

Aromatase Inhibitors

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.

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

Fecal swab collection

Participants will have approximately 1 teaspoon of blood withdrawn from a vein, for research, on 2 different occasions. The total amount of blood withdrawn during the study will be approximately 2 teaspoons.

Blood samples

Study Coordinator

Katherine Ansley, MD

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.

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.

* 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.

Oral Aromatase Inhibitors Modify the Gut Microbiome

Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oral Aromatase Inhibitors Modify the Gut Microbiome	NCT05030038	Breast Cancer	Fecal swab coll... Blood samples	18 Years -	Wake Forest University Health Sciences
Oral Aromatase Inhibitors Modify the Gut Microbiome	NCT05030038	Breast Cancer	Fecal swab coll... Blood samples	18 Years -	Wake Forest University Health Sciences
Oral Aromatase Inhibitors Modify the Gut Microbiome	NCT05030038	Breast Cancer	Fecal swab coll... Blood samples	18 Years -	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for circulating sex hormone metabolite concentrations