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Completed
NCT05030038
Oral Aromatase Inhibitors Modify the Gut Microbiome
Conditions: Breast Cancer
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 24
Sponsor: Wake Forest University Health Sciences
Location: Wake Forest Baptist Health Sciences Winston-Salem North Carolina
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.
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
Source: ClinicalTrials.gov (NCT05030038). StuddyBuddy aggregates publicly available trial information.