Tamoxifen Pharmacogenetics and Clinical Effects
Completed
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00228930
- Run by
- National Institute of General Medical Sciences (NIGMS)
- People needed
- 297
- Starts
- 2002-09-01
- Expected to finish
- 2007-08-01
- Last updated by the study team
- 2008-09-25
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- Indiana University — Indianapolis, Indiana, United States
- UMCCC — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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