Karolinska Interventional Study of Mammograhic Density (Karisma-1)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Mammographic Density Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

The investigators want to conduct a feasibility study including 42 women who will be randomised to either 10 or 20 mg of daily oral tamoxifen. The primary aim of the study 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 daily 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 of the pilot study is to see if there is a density change from 10 mg of tamoxifen equivalent to 20 mg and if there is a difference in adverse reactions between the two doses. Interim analysis will be performed at 6 months, monitoring both safety and level of mammographic density change.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Previously participated in the Karma study
Attending the national mammography screening program, i.e. aged 40-74
A mammogram, including a stored raw image, must have been taken within 3 weeks of baseline and start of therapy
Having a mammographic volumetric density above the lowest 1/6, measured by Volpara
Informed consent must be signed before any study specific assessments have been performed

Exclusion criteria

Being pregnant or planning to become pregnant during the study
Any previous or current diagnosis of breast cancer (including carcinoma in situ)
Recalled (mammographic code 3 or above) after baseline screening mammography
Any previous diagnosis of cancer, with the exception of non-melanoma skin cancer and in situ cancer of the cervix
Currently using oestrogen and progesterone-based hormone replacement therapy
Current use of hormone contraceptive with hormones, e.g. hormonal contraceptive pills, or progesterone implants. Hormonal intrauterine devices are accepted.
A history of thromboembolic disease such as embolism, deep vein thrombosis, stroke, TIA or cardiac arrest.
A history of immobilization, e.g. using wheelchair
Uncontrolled diabetes defined as known untreated diabetes
Hypertension at baseline, defined as systolic pressure higher than 140 mm Hg and diastolic higher than 90 mm Hg
Use of drugs that interfere with CYP2D6 expression such as paroxetine, fluoxetine and bupropion

Treatment and study plan

Tamoxifen

Drug

A registered SERM drug, Tamoxifen.

Primary outcomes

Mammographic Breast Density

Time frame: 6 months

Mean change in mammographic breast density at 6 months compared to baseline (=0 months) for each dose arm, using the fully automated STRATUS method. The average percent density (fibroglandular dense tissue area divided by total breast area) of left and right breasts at baseline was calculated and compared with average percent density at the end of the trial period and density change was defined as the difference between these two measures.

Secondary outcomes

Symptom Score

Time frame: 9 months

Symptom score change, compared to baseline for each dose arm. Questionnaires were used at 0, 1, 3, 6, 9 months. Vasomotor, gynecological, sexual, and musculoskeletal symptoms were assessed using a 5-grade Likert severity scale ranging from "no symptom at all" to "very much symptoms". A higher symptom score equals less symptoms, i.e. a better outcome.

The questionnaire was based on the Functional Assessment of Cancer Therapy - Endocrine Subscale 7 (FACT-ES.7).

The presented score was calculated as the sum of the last month's symptom severity levels and are presented as the absolute differences in symptom score on a scale ranging from any minus five to any plus five. A higher symptom score equals less symptoms, i.e. a better outcome.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: Karisma-1

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Sep 6, 2019
Registry last updated: Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed