Overview
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
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