Effect of Pharmacogenomics Differences in Phase I and II Metabolism of Tamoxifen on Efficacy and Toxicity

Completed

Conditions studied: Breast Cancer, Ductal Carcinoma in Situ

In brief

This study will be an open-label prospective observational trial designed to test associations between polymorphisms of candidate genes and tamoxifen. Pre- and post-menopausal women taking tamoxifen as standard therapy or chemopreventive therapy will be included in this study.

Key facts

Study ID

NCT00886535

Run by

Milton S. Hershey Medical Center

People needed

41

Starts

2010-02-01

Expected to finish

2017-07-27

Last updated by the study team

2019-03-14

Who can join

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

You may qualify if…

• Patients receiving tamoxifen for adjuvant therapy of breast cancer or ductal carcinoma in situ, or as chemoprevention
• Age 18 years and above
• May be pre- and post-menopausal
• Females
• Patients may be at any point in their hormonal treatment, but must have completed any planned surgery, radiation and chemotherapy
• Must use a reliable form of birth control

You may not qualify if…

• Pregnant
• Breastfeeding
• Concurrent use of corticosteroids, megestrol, or phenobarbital
• History of allergy to tamoxifen
• Unwilling to have a yearly gynecological exam

Where it is running

• Penn State Hershey Cancer Institute — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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