NCT03346200

Low Dose Tamoxifen for Mammographic Density Reduction

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,440 (actual)
• Sponsor: Per Hall · Academic / Other
• Sex: Female
• Age: 40 Years – 74 Years
• Healthy volunteers: Accepted

Summary

KARISMA2 is a randomized, double-blinded, six-armed placebo controlled study to identify a low dose of tamoxifen, with less side-effects and a density reduction non-inferior to the standard dose of 20 mg.

Detailed description

This is a dose determination study aiming to identify the optimal tamoxifen dose for reducing the risk of breast cancer. 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. 1440 healthy women 40-74 yrs were included when adhering the national Swedish mammography screening program between 2016- 2019. Women were randomized and treated daily for 6 months. Mammograms were taken at baseline and at end of treatment and side effects were measured throughout the study trough schedueled questionnaires and spontaneous AE-reporting.

Conditions

• Risk Reduction
• Mammographic Density Reduction

Interventions

Type	Name	Description
DRUG	Tamoxifen Oral Tablet	Randomised dose of tamoxifen 1 pill/day for 180 days
DRUG	Placebo Oral Tablet	Randomised dose of tamoxifen 1 pill/day for 180 days

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-10-01
• Completion: 2019-12-01
• First posted: 2017-11-17
• Last updated: 2025-03-07
• Results posted: 2025-03-07