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Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
Wake Forest Baptist Health Sciences
RECRUITING
Winston-salem
Contact Information
Primary
Study Coordinator
jriley@wakehealth.edu
336-713-5435
Time Frame
Start Date: 2022-03-29
Estimated Completion Date: 2026-07
Participants
Target number of participants: 25
Treatments
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.
Authors
Alexander Thomas, Alexandra Thomas, Akiko Chiba
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov