Tamoxifen Pharmacogenetics and Clinical Effects

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00228930
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-09-27
• Study First Submitted QC: 2005-09-27
• Study First Posted: 2005-09-29
• Study Completion: 2007-08
• Status Verified: 2007-11
• Last Update Submitted: 2008-09-24
• Last Update Posted: 2008-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 297

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

UMCCC; 🇺🇸 Ann Arbor, Michigan, United States