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Tamoxifen Pharmacogenetics and Clinical Effects | Clinical Trials | Clareo Health

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Tamoxifen Pharmacogenetics and Clinical Effects

A Pilot Trial Correlating Metabolic Profile of Tamoxifen With Pharmacogenetic Predictors and Clinical Effects

NCT00228930•National Institute of General Medical Sciences (NIGMS)

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.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

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.

Locations (2)

Indiana University

Indianapolis, Indiana, United States

UMCCC

Ann Arbor, Michigan, United States

Key Dates

Start Date

September 1, 2002

Completion Date

August 1, 2007

Last Updated

September 25, 2008

Enrollment

297

ACTUAL participants

Conditions

Breast Cancer

Interventions

Tamoxifen (pharmacodynamic analysis)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 25, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Tamoxifen Pharmacogenetics and Clinical Effects

Inclusion Criteria

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