Status:
COMPLETED
Effect of Pharmacogenomics Differences in Phase I and II Metabolism of Tamoxifen on Efficacy and Toxicity
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Breast Cancer
Ductal Carcinoma in Situ
Eligibility:
FEMALE
18+ years
Brief Summary
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 a...
Detailed Description
This study will be an open-label prospective observational trial designed to test associations between polymorphisms of candidate genes (focusing initially on the UGT2B7 enzyme) and tamoxifen (TAM) to...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Pregnant
- Breastfeeding
- Concurrent use of corticosteroids, megestrol, or phenobarbital
- History of allergy to tamoxifen
- Unwilling to have a yearly gynecological exam
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 27 2017
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00886535
Start Date
February 1 2010
End Date
July 27 2017
Last Update
March 14 2019
Active Locations (1)
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1
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States, 17033