Impact of Oral Aromatase Inhibitors on Gut Bacteria in Breast Cancer Patients
Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability
This study is testing how taking oral aromatase inhibitors affects gut bacteria in women with breast cancer before and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05030038 on ClinicalTrials.gov |
What this trial studies
This research aims to investigate the changes in gut microbiome composition in patients with breast cancer before and after treatment with oral aromatase inhibitors. Participants will undergo fecal swab collection and blood sampling to assess the microbiome and circulating sex hormone metabolite concentrations at baseline, 4 weeks, and 12 weeks post-treatment. The study will correlate shifts in gut bacteria with changes in hormone levels, providing insights into the relationship between gut health and breast cancer treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of in situ or invasive breast cancer who are starting aromatase inhibitor therapy.
Not a fit: Patients who have received antibiotics or chemotherapy recently, or those on hormone replacement therapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how gut microbiome modifications may influence treatment outcomes in breast cancer patients.
How similar studies have performed: While the correlation between gut microbiome and cancer treatment is an emerging field, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Baptist Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Katherine Ansley, MD — Wake Forest Baptist Health Sciences
- Study coordinator: Study Coordinator
- Email: jriley@wakehealth.edu
- Phone: 336-713-5435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.