Effect of Pharmacogenomics Differences in Phase I and II Metabolism of Tamoxifen on Efficacy and Toxicity
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.
Ductal Carcinoma in Situ
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||An Observational Trial of the Effect of Pharmacogenomics Differences in Phase I and II Metabolism of Tamoxifen on Efficacy and Toxicity|
- Hot flashes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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) toxicity. Pre- & post-menopausal women (aged ≥18 years) taking TAM (20 mg/day) as standard therapy or chemopreventive therapy will be included in this study. Patients will be enrolled after they complete all primary surgery, radiation, and adjuvant chemotherapy. Patients will be excluded if they are undergoing other adjuvant endocrine therapies. Other reasons for exclusion will include patients who are pregnant or lactating, or are currently on corticosteroids, phenobarbital, or megestrol acetate. The goal will be to recruit a total of 45 eligible patients over a 1 year accrual period. The investigators expect to treat ~50 new patients per year with TAM at the standard dose of 20 mg/day.
|United States, Pennsylvania|
|Penn State Hershey Cancer Institute|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Leah Cream, MD||Penn State Hershey Cancer Institute|