40
Participants
Start Date
March 1, 2011
Primary Completion Date
June 1, 2020
Study Completion Date
June 1, 2026
Z-Endoxifen
Genetic polymorphisms in CYP2D6 and concomitant medications alter tamoxifen metabolism, limiting exposure to the active metabolite endoxifen. These factors are associated with a higher rate of recurrence and shorter disease-free survival in breast cancer patients receiving tamoxifen. Administration of endoxifen directly to patients is anticipated to bypass the effects of CYP2D6 polymorphisms and concomitant medications and provide adequate active drug levels in all treated patients, resulting in clinical benefit.
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH