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Tamoxifen Pharmacogenetics and Clinical Effects

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Biomarker/Laboratory analysis, Natural history/Epidemiology, Treatment

Completed

18 to 70

NIGMS

0208-14
UO1-GM61373-05, NCT00228930

Trial Description

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.

Further Study Information

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.

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

National Institute of General Medical Sciences

Indiana University Melvin and Bren Simon Cancer Center

David Flockhart, MD, PhD

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00228930
Information obtained from ClinicalTrials.gov on September 25, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.