Oral Aromatase Inhibitors Modify the Gut Microbiome

Wake Forest University (WFU)

Status: Enrolling

Conditions: Breast Cancer

Treatments: Biological: Fecal swab collection; Biological: Blood samples

Study type: Observational

Funder types: Other

Identifiers

NCT05030038

IRB00076577

WFBCCC 74121 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 1 patient group

Aromatase inhibitor for breast cancer treatment

Description:

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.

Treatment:

Biological: Blood samples

Biological: Fecal swab collection