Breast Cancer
Conditions
Keywords
Gut microbiome, Circulating sex hormone metabolite concentrations
Brief 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.
Detailed 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.
Interventions
BIOLOGICALFecal swab collection
Participants will collect fecal sample at home and either mail in the sample, or drop it off at the lab
BIOLOGICALBlood samples
Participants will have approximately 1 teaspoon of blood withdrawn from a vein, for research, on 2 different occasions. The total amount of blood withdrawn during the study will be approximately 2 teaspoons.
Sponsors
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gut Microbial Levels - Fecal Swab | At baseline, 4 weeks and 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gut Microbial Levels - Blood Samples | At baseline and at 12 weeks | 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. |
| Change in Sex Hormone Concentrations - Blood Samples | At baseline and at 12 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatherine Ansley, MD
Wake Forest Baptist Health Sciences
Outcome results
None listed