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Brief Title: Tamoxifen Pharmacogenetics and Clinical Effects
Official Title: A Pilot Trial Correlating Metabolic Profile of Tamoxifen With Pharmacogenetic Predictors and Clinical Effects
Study ID: NCT00228930
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Indiana University, Indianapolis, Indiana, United States
UMCCC, Ann Arbor, Michigan, United States
Name: David Flockhart, MD, PhD
Affiliation: Indiana University School of Medicine
Role: PRINCIPAL_INVESTIGATOR