Our aim of the Karma CREME trial is to test if topical application of endoxifen reduce mammographic density with lower levels of side effects compared to oral tamoxifen. Tamoxifen is more or less inactive and needs to be metabolised to any of the two active metabolites afimoxifen or endoxifen. We are testing topical application of endoxifen directly to the skin of the breast expecting the compound to penetrate in to the glandular tissue.
In collaboration with the US company Atossa Genetics [www.atossagenetics.com] we have launched a pilot study, testing the hypothesis that topical application of endoxifen can generate an individual change in mammographic density.
Ninety participants have been randomised to one of three groups (one placebo group and two groups on different doses of topical endoxifen). The objective of the study is to determine the effect size of breast density between the topical and active groups, which will permit sample size calculations in a future Phase III study.
The study closed for inclusion during the second half of 2018. First results are anticipated during spring 2019.