Oral Aromatase Inhibitors Modify the Gut Microbiome

Breast Cancer Clinical Trial

Official title:

Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05030038
• Other study ID #: IRB00076577
• Secondary ID: WFBCCC 74121
• Status: Recruiting
• Start date: March 29, 2022
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: Wake Forest University Health Sciences
• Contact: Study Coordinator
• Phone: 336-713-5435
• Email: jriley[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Biological:
• Fecal swab collection
Participants will collect fecal sample at home and either mail in the sample, or drop it off at the lab
• Blood 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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gut Microbial Levels - Fecal Swab	To describe the microbiome shift of gut microbiome from baseline after 4-weeks and 12-weeks of oral aromatase inhibitor treatment Investigators will calculate the change in gut microbial levels using paired t-tests.	At baseline, 4 weeks and 12 weeks
Secondary	Change in Gut Microbial Levels - Blood Samples	Investigators will calculate Pearson or Spearman correlation coefficients between diversity and gut microbial levels and circulating sex hormone metabolite concentrations at baseline and at 12 weeks. Bacterial derived bioactive compounds, bile acids, and glucuronidated sex hormones will be compared by metabolomics conducted on plasma.	At baseline and at 12 weeks
Secondary	Change in Sex Hormone Concentrations - Blood Samples	Investigators will fit a model with independent variables of the value (baseline or 12 weeks), and a second variable that represents the change from baseline (will be 0 or the change at 12 weeks).; Estrone, estrone-3-glucuronide, and estrone-3-sulfate concentrations will be measured using an ELISA assay conducted on plasma.	At baseline and at 12 weeks