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Tamoxifen Pharmacogenetics and Clinical Effects

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ClinicalTrials.gov Identifier: NCT00228930
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : September 25, 2008
Indiana University School of Medicine
Information provided by:
National Institute of General Medical Sciences (NIGMS)

September 27, 2005
September 29, 2005
September 25, 2008
September 2002
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Complete list of historical versions of study NCT00228930 on ClinicalTrials.gov Archive Site
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Tamoxifen Pharmacogenetics and Clinical Effects
A Pilot Trial Correlating Metabolic Profile of Tamoxifen With Pharmacogenetic Predictors and Clinical Effects
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.

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.
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Whole Blood Serum Plasma
Non-Probability Sample
Eligible patients included women 18 years or older, non-pregnant or lactating, who were recommended tamoxifen for adjuvant treatment or for the prevention of breast cancer from the oncology clinics.
Breast Cancer
Drug: Tamoxifen (pharmacodynamic analysis)
Tamoxifen 20mg po daily
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2007
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Inclusion Criteria:

  1. 18-years or older
  2. Women with a prior breast cancer or who are at a high risk for developing the disease and about to start tamoxifen therapy.
  3. Participants must not be treated with concomitant chemotherapy or hormone therapy other than tamoxifen. They must not have ovarian ablation or currently being treated with radiation therapy and/or chronic corticosteroids.
  4. The participant must not be taking anti-hot flash therapy (clonidine, bellergal, megestrol acetate). Vitamin E, selective serotonin reuptake inhibitors, or herbal remedies are allowed provided that the participant has been taking the remedy for at least 4 weeks and intends to continue the remedy for at least the first month while on the study, and allows for one-month follow up evaluation (hot flash diaries and blood samples).
  5. The participant must not be pregnant or lactating.
  6. The participant is able and willing to sign an informed consent.
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
U01GM061373-05 ( U.S. NIH Grant/Contract )
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National Institute of General Medical Sciences (NIGMS)
Indiana University School of Medicine
Principal Investigator: David Flockhart, MD, PhD Indiana University School of Medicine
National Institute of General Medical Sciences (NIGMS)
November 2007