CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Tamoxifendrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04079517
NCT04079517Phase 2Completed

A Randomized, Open Pilot Study to Investigate the Mammographic Density Reduction on Healthy Women, Within the Karma Cohort, for Two Different Doses of Tamoxifen

Karolinska Institutet·interventional·Posted Sep 6, 2019·Updated Feb 6, 2025

In Brief

A Phase 2 clinical trial evaluating Tamoxifen for Breast Cancer and Mammographic Density. Completed, enrolled 42 participants.

Detailed Summary

A feasibility study, randomising to either 10 or 20 mg of tamoxifen. The primary aim is to identify the time to mammographic density change and piloting the procedures. It is known that a density change is seen after 12 months of 20 mg of tamoxifen, but the clinical experience indicates that an effect of drugs influencing mammographic density could be seen already after a few months. The second aim is to evaluate if there is a density change from 10 mg of tamoxifen equivalent to 20 mg.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 6, 2019
Enrollment StartMar 1, 2015
Primary CompletionFeb 1, 2016
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.8 years ago

Interventions

Tamoxifendrug

A registered SERM drug, Tamoxifen.