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Karma Intervention Study — Karisma 2  

Risk Reduction Clinical Trial

Official title:
A Randomised, Double Blinded, Six-armed Placebo Controlled Study to Investigate Optimal Dose of Tamoxifen With the Most Favourable Side Effect Spectre and With Mammography Density Reduction Non-inferior to That of 20 mg Tamoxifen (Karisma 2)

Clinical Trial Summary

This is a dose determination study aiming to identify the optimal tamoxifen dose for reducing the risk of breast cancer. Instead of following a very large number of women, for many years, treated with different doses of tamoxifen and see if they develop breast cancer, the investigators will include 1,440 healthy women participating in the mammographic screening program at two Mammography units (Unilabs mammography, Lund and Södersjukhuset Breast Centre, Stockholm) and measure their change in mammographic density. The change in mammographic density is a very good marker of therapy response. Investigators will test if 1 mg, 2.5 mg, 5 mg and 10 mg reduce the mammographic density to the same extent as 20 mg. In summary Karisma 2 will be a randomized, double-blinded, six-armed placebo controlled study to identify the dose of tamoxifen with the most favourable side effect spectra and with a density reduction non-inferior to 20 mg tamoxifen.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03346200
Study type Interventional
Source Karolinska Institutet
Contact
Status Completed
Phase Phase 2
Start date November 2016
Completion date December 2019
View Details
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