Status:
COMPLETED
Tamoxifen Pharmacogenetics and Clinical Effects
Lead Sponsor:
National Institute of General Medical Sciences (NIGMS)
Collaborating Sponsors:
Indiana University School of Medicine
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
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 res...
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 18-years or older
- Women with a prior breast cancer or who are at a high risk for developing the disease and about to start tamoxifen therapy.
- 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.
- 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).
- The participant must not be pregnant or lactating.
- The participant is able and willing to sign an informed consent.
Exclusion
Key Trial Info
Start Date :
September 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
297 Patients enrolled
Trial Details
Trial ID
NCT00228930
Start Date
September 1 2002
End Date
August 1 2007
Last Update
September 25 2008
Active Locations (2)
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1
Indiana University
Indianapolis, Indiana, United States, 46202
2
UMCCC
Ann Arbor, Michigan, United States, 48109