Clinical trial NCT05030038: Oral Aromatase Inhibitors Modify the Gut Microbiome
Official title: Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Gut microbiome
Circulating sex hormone metabolite concentrations
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women of all races and ethnicity who meet the eligibility criteria are eligible for this trial.

Brief 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.

Detailed 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 criteria: 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

Primary outcomes:
measure: Change in Gut Microbial Levels - Fecal Swab
timeFrame: At baseline, 4 weeks and 12 weeks
Secondary outcomes:
measure: Change in Gut Microbial Levels - Blood Samples
timeFrame: At baseline and at 12 weeks
measure: Change in Sex Hormone Concentrations - Blood Samples
timeFrame: At baseline and at 12 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Health Sciences
name: Katherine Ansley, MD
role: PRINCIPAL_INVESTIGATOR
References: