NCT00228930

Tamoxifen Pharmacogenetics and Clinical Effects

A Pilot Trial Correlating Metabolic Profile of Tamoxifen With Pharmacogenetic Predictors and Clinical Effects

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 297 (actual)
• Sponsor: National Institute of General Medical Sciences (NIGMS) · NIH
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to try to identify which women who take tamoxifen are likely to suffer from hot flashes or are more likely to have other side effects or benefits from the drug. The researchers will do so by determining whether there are mutations that normally occur in human DNA that might influence the way individuals respond to medications.

Detailed description

The study will test the following hypotheses. 1. There is a relationship between genetically distinct metabolic profiles of tamoxifen and the frequency and severity of hot flashes in women on chronic tamoxifen therapy. 2. Genetically distinct metabolic profiles for tamoxifen effect lipid profile, bone turnover metabolites and bone mineral density, and coagulation factors. 3. Different genetic profiles of estrogen responsive genes influence the pharmacodynamic effects of tamoxifen in cardiovascular system.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Tamoxifen (pharmacodynamic analysis)	Tamoxifen 20mg po daily

Timeline

• Start date: 2002-09-01
• Completion: 2007-08-01
• First posted: 2005-09-29
• Last updated: 2008-09-25

Locations

2 sites across 1 country: United States