This study examines the bacteria in the gut before and after receiving the aromatase inhibitor drug in patients with breast cancer. Aromatase inhibitors stop the production of estrogen in postmenopausal women. Studying samples of blood and fecal matter from patients with breast cancer receiving aromatase inhibitor in the laboratory, may help doctors learn about the differences in the bacteria before and after the drug has been taken.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05030038.
Locations matching your search criteria
United States
North Carolina
Winston-Salem
Wake Forest University Health SciencesStatus: Active
Contact: Katherine Ansley
Phone: 336-713-0037
PRIMARY OBJECTIVE:
I. To describe the microbiome shift of gut microbiome from baseline after 4-weeks and 12-weeks of oral aromatase inhibitor treatment.
SECONDARY OBJECTIVES:
I. To correlate gut microbiome populations with circulating sex hormone metabolite concentrations at baseline and 12 weeks.
II. To describe the correlation of change in the microbiome populations with change in circulating sex hormone metabolite concentrations from baseline to 12 weeks.
OUTLINE:
Patients undergo collection of blood samples at baseline and 12 weeks, undergo collection of fecal matter samples at baseline, 4, and 12 weeks, and also complete questionnaires at week 12.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorKatherine Ansley