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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 74121 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aromatase inhibitor for breast cancer treatment | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal swab collection | Biological | Participants will collect fecal sample at home and either mail in the sample, or drop it off at the lab |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Gut Microbial Levels - Fecal Swab | To describe the microbiome shift of gut microbiome from baseline after 4-weeks and 12-weeks of oral aromatase inhibitor treatment Investigators will calculate the change in gut microbial levels using paired t-tests. | At baseline, 4 weeks and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gut Microbial Levels - Blood Samples | Investigators will calculate Pearson or Spearman correlation coefficients between diversity and gut microbial levels and circulating sex hormone metabolite concentrations at baseline and at 12 weeks. Bacterial derived bioactive compounds, bile acids, and glucuronidated sex hormones will be compared by metabolomics conducted on plasma. | At baseline and at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Women of all races and ethnicity who meet the eligibility criteria are eligible for this trial.
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Ansley, MD | Wake Forest Baptist Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 13, 2026 | Jun 11, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Blood samples | Biological | Participants will have approximately 1 teaspoon of blood withdrawn from a vein, for research, on 2 different occasions. The total amount of blood withdrawn during the study will be approximately 2 teaspoons. |
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| Change in Sex Hormone Concentrations - Blood Samples | Investigators will fit a model with independent variables of the value (baseline or 12 weeks), and a second variable that represents the change from baseline (will be 0 or the change at 12 weeks). Estrone, estrone-3-glucuronide, and estrone-3-sulfate concentrations will be measured using an ELISA assay conducted on plasma. | At baseline and at 12 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |