Oral Aromatase Inhibitors Modify the Gut Microbiome
Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability
Wake Forest University Health Sciences
25 participants
Mar 29, 2022
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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
Interventions
Participants will collect fecal sample at home and either mail in the sample, or drop it off at the lab
Participants will have approximately 1 teaspoon of blood withdrawn from a vein, for research, on 2 different occasions. The total amount of blood withdrawn during the study will be approximately 2 teaspoons.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05030038