Breast CancerNCT05030038
Oral Aromatase Inhibitors Modify the Gut Microbiome
An observational study of Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fecal swab collection and Blood samples
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2022to 28 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women of all races and ethnicity who meet the eligibility criteria are eligible for this trial.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Fecal swab collection, Blood samples
- Keywords
- Gut microbiome, Circulating sex hormone metabolite concentrations
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal swab collectionBiological
Participants will collect fecal sample at home and either mail in the sample, or drop it off at the lab
Blood samplesBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Fecal swab collection; Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, 4 weeks and 12 weeks
Secondary outcomes (2)
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.
Measured: At baseline and at 12 weeks
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.
Measured: At baseline and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start29 Mar 2022
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Katherine Ansley, MD, Principal investigator, Wake Forest Baptist Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030038
- Sponsor's protocol ID
- IRB00076577
- Other IDs
- WFBCCC 74121, P30CA012197
- Status last verified
- Jun 2026
- First submitted
- 25 Aug 2021
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability
- ClinicalTrials.gov ID
- NCT05030038
- Acronym / sponsor ID
- IRB00076577
- Conditions
- Breast Cancer
- Keywords
- Gut microbiome, Circulating sex hormone metabolite concentrations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aromatase inhibitor for breast cancer treatment | – | Biological: Fecal swab collection, Biological: Blood samplesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women of all races and ethnicity who meet the eligibility criteria are eligible for this trial.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal swab collectionParticipants will collect fecal sample at home and either mail in the sample, or drop it off at the lab | Biological | Aromatase inhibitor for breast cancer treatment |
| Blood samplesParticipants 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. | Biological | Aromatase inhibitor for breast cancer treatment |
Primary outcome
Change in Gut Microbial Levels - Fecal Swab
Time frame: 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.
2 secondary outcomes
Change in Gut Microbial Levels - Blood Samples
Time frame: At baseline and at 12 weeks
Change in Sex Hormone Concentrations - Blood Samples
Time frame: At baseline and at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Ansley, MD principal investigator
Wake Forest Baptist Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gut Microbial Levels - Fecal Swab (time frame: At baseline, 4 weeks and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.