Clinical trial · Observational
Oral Aromatase Inhibitors Modify the Gut Microbiome
Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability
NCT05030038CI-TRIAL-00114734completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples | Biological | — | UNRESOLVED |
| Fecal swab collection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Aromatase inhibitor for breast cancer treatment
- description
- 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.
- interventionNames
- Biological: Fecal swab collection
- Biological: Blood samples
Primary outcomes (1)
- measure
- Change in Gut Microbial Levels - Fecal Swab
- timeFrame
- At baseline, 4 weeks and 12 weeks
- description
- 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 outcomes (2)
- measure
- Change in Gut Microbial Levels - Blood Samples
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.