Metabolizing Enzyme Genotype Versus Exemestane Metabolism Profiles

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01626144

Run by

Milton S. Hershey Medical Center

People needed

170

Starts

2011-09-01

Expected to finish

2018-05-01

Last updated by the study team

2018-05-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Concurrent use of corticosteroids, megestrol, or phenobarbitol (inhaled and internasal steroids are permitted)
• History of allergy to exemestane

Where it is running

• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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