Breast Cancer Clinical Trial
Oral Aromatase Inhibitors Modify the Gut Microbiome
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.
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.
Eligibility Criteria
Inclusion Criteria:
Pathologic diagnosis of invasive breast cancer ER+ and/or PR+ by IHC (>10% staining), HER2 negative
Postmenopausal women diagnosed with ER+/PR+ invasive breast cancer (unilateral, bilateral, multifocal disease will be eligible provided that all invasive cancers are ER and/or PR +)
Menopause defined as cessation of menstrual cycle for 12 months or determined by follicle-stimulation hormone (FSH) of >40 mlU/mLand estradiol levels of <30 pg/mL level.
No history of breast cancer (DCIS or invasive breast cancer) in either breast prior to the current breast cancer diagnosis
ECOG performance status 0,1,or 2
Completed surgery and planned completion of radiation therapy before initiating aromatase inhibitor
Recommended aromatase inhibitor for systemic treatment of breast cancer
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.
Have HER2 amplified breast cancer
Have triple negative breast cancer
Administered chemotherapy < 4 weeks prior to endocrine therapy initiation
Prior endocrine therapy
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
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There is 1 Location for this study
Winston-Salem North Carolina, 27157, United States More Info
Principal Investigator
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