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.

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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.

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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

Study is for people with:

Breast Cancer

Estimated Enrollment:

25

Study ID:

NCT05030038

Recruitment Status:

Recruiting

Sponsor:

Wake Forest University Health Sciences

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There is 1 Location for this study

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Wake Forest Baptist Health Sciences
Winston-Salem North Carolina, 27157, United States More Info
Study Coordinator
Contact
336-713-6069
[email protected]
Alexander Thomas, MD
Principal Investigator

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Study is for people with:

Breast Cancer

Estimated Enrollment:

25

Study ID:

NCT05030038

Recruitment Status:

Recruiting

Sponsor:


Wake Forest University Health Sciences

How clear is this clinincal trial information?

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