Tamoxifen Pharmacogenetics and Clinical Effects

This study has been completed.
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by:
National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00228930
First received: September 27, 2005
Last updated: September 24, 2008
Last verified: November 2007

September 27, 2005
September 24, 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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.
 
Completed
297
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.
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00228930
0208-14, UO1-GM61373-05
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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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP