Clinical trial · Observational
Metabolizing Enzyme Genotype Versus Exemestane Metabolism Profiles
- 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)
It is the investigators hypothesis that exemestane (EXE) metabolism is an important source of the inter-individual variation in EXE metabolic profiles and that polymorphisms in EXE-metabolizing enzymes may potentially play a role in affecting EXE therapeutic efficacy and toxicity. The goals of this clinical study are to (1) establish EXE metabolism profile kinetics, and (2) determine whether correlations exist in vivo between metabolizing enzyme genotype and urinary EXE metabolite profiles in women being treated with EXE. Together, these studies will allow us to fully characterize functionally-relevant polymorphisms in the EXE-metabolizing enzyme pathway that are potentially important in EXE clinical efficacy.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer, exemestane treatment
- description
- Breast cancer patients receiving standard of care exemestane
Primary outcomes (1)
- measure
- Metabolizing enzyme genotype vs EXE metabolism profiles
- timeFrame
- 6 years
- description
- Functional genotypes will be determined for EXE-metabolizing enzymes and will be correlated with blood/urinary EXE metabolism profiles
Secondary outcomes (1)
- measure
- EXE toxicities
- timeFrame
- 6 years
- description
- Patient-reported EXE-induced toxicities will be measured.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer patients who have ER+ tumors and are taking 25 mg EXE daily (orally) * Post-menopausal women or chemically post-menopausal women (who won't become pregnant since they are taking zoladex), or women who are post-menopausal as a result of ovary removal * Patients may be at any point in their hormonal treatment, but must have completed any planned surgery, radiation and chemotherapy. Exclusion Criteria: * Concurrent use of corticosteroids, megestrol, or phenobarbitol (inhaled and internasal steroids are permitted) * History of allergy to exemestane
References
Publications (0)
Data not yet available