Status:
COMPLETED
Tamoxifen in Women With Breast Cancer and in Women at High-Risk of Breast Cancer Who Are Receiving Venlafaxine, Citalopram, Escitalopram, Gabapentin, or Sertraline
Lead Sponsor:
Mayo Clinic
Conditions:
Breast Cancer
Depression
Eligibility:
All Genders
18-120 years
Brief Summary
RATIONALE: Studying samples of blood in the laboratory from patients receiving tamoxifen may help doctors learn more about the effects of other drugs on the level of tamoxifen in the blood. PURPOSE: ...
Detailed Description
OBJECTIVES: * To examine the changes in the plasma concentrations of the hydroxylated metabolite, 4-hydroxy tamoxifen, and endoxifen in women with known or at high risk for developing breast cancer w...
Eligibility Criteria
Inclusion
- Prescribed tamoxifen either for the prevention or treatment of non-invasive or invasive breast cancer.
- Tamoxifen use \> 4 weeks without any breaks at a dose of 20 mg/day prior to registration
- to begin medical therapy with one of the following drugs: venlafaxine, citalopram, escitalopram, sertraline or gabapentin as determined by their physician
- Agree to continue tamoxifen during the proposed minimum study period of 8 weeks
- Willing to avoid known inhibitors of the CYP2D6 system for duration of study
- Ability to provide informed consent
- Willing to return to primary site of enrollment for follow-up
- Life expectancy \>= 16 weeks
- Agree to provide a blood specimen at the time of pre-treatment (baseline) and at follow-up
Exclusion
- Contraindication to the use of venlafaxine, citalopram, escitalopram, gabapentin or sertraline.
- Use of medications that are known to inhibit the CYP2D6 system within 3 weeks of registration. (see appendix II for list)
- Known to be a CYP2D6 poor metabolizer (defined as homozygous for one of the following CYP2D6 null alleles: \*3, \*4, \*5, \*6).
- Note: CYP2D6 genotyping is not required prior to enrollment; however, CYP2D6 genotyping will be performed at baseline and the treating physician will be notified of the results: all genotypic CYP2D6 PM will be replaced
Key Trial Info
Start Date :
March 16 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 27 2014
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00667121
Start Date
March 16 2011
End Date
May 27 2014
Last Update
February 14 2025
Active Locations (6)
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1
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
3
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
4
Mayo Clinic
Rochester, Minnesota, United States, 55905