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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
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by:
National Institute of General Medical Sciences (NIGMS)

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.

Condition or disease Intervention/treatment
Breast Cancer Drug: Tamoxifen (pharmacodynamic analysis)

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.

Study Type : Observational
Actual Enrollment : 297 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Trial Correlating Metabolic Profile of Tamoxifen With Pharmacogenetic Predictors and Clinical Effects
Study Start Date : September 2002
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Tamoxifen (pharmacodynamic analysis)
    Tamoxifen 20mg po daily


Biospecimen Retention:   Samples With DNA
Whole Blood Serum Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228930


Locations
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Michigan
UMCCC
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
National Institute of General Medical Sciences (NIGMS)
Indiana University School of Medicine
Investigators
Principal Investigator: David Flockhart, MD, PhD Indiana University School of Medicine

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00228930     History of Changes
Other Study ID Numbers: 0208-14
U01GM061373-05 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: September 25, 2008
Last Verified: November 2007

Keywords provided by National Institute of General Medical Sciences (NIGMS):
Breast Cancer
Tamoxifen
Prevention

Additional relevant MeSH terms:
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents