Oral Aromatase Inhibitors Modify the Gut Microbiome

Description

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.

Conditions

Breast Cancer

Study Overview

Study Details

Study overview

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.

Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability

Oral Aromatase Inhibitors Modify the Gut Microbiome

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Wake Forest Baptist Health Sciences, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Katherine Ansley, MD, PRINCIPAL_INVESTIGATOR, Wake Forest Baptist Health Sciences

Study Record Dates

2024-12