Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability
Wake Forest University Health Sciences
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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. Exclu…
Interventions
- BiologicalFecal swab collection
Participants will collect fecal sample at home and either mail in the sample, or drop it off at the lab
- BiologicalBlood samples
Participants will have approximately 1 teaspoon of blood withdrawn from a vein, for research, on 2 different occasions. The total amount of blood withdrawn during the study will be approximately 2 teaspoons.
Location
- Wake Forest Baptist Health SciencesWinston-Salem, North Carolina