Low Dose Tamoxifen for Mammographic Density Reduction (NCT03346200) | Clinical Trial Compass
CompletedPhase 2
Low Dose Tamoxifen for Mammographic Density Reduction
1,440 participantsStarted 2016-11
Plain-language 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.
Who can participate
Age range40 Years – 74 Years
SexFEMALE
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Inclusion Criteria:
* Attending the national mammography screening program, i.e. aged 40-74 and has performed a screening mammogram maximum 3 months prior to study inclusion
* Having a measurable mammographic density, i.e. ≥4.5 % density (volumetric) measured by Volpara
* Informed consent must be signed before any study specific assessments have been performed
Exclusion Criteria:
* Pregnancy at start, during time of study medication and up to 3 months after quitting study medication
* Breast feeding at start, during time of study medication and up to 3 months after quitting study medication
* Any previous or current diagnosis of breast cancer (including carcinoma in situ)
* Mammographic BI-RADS code 3 or above at baseline mammography, or at a diagnostic mammography during time of treatment (the first 6 months of the study)
* Any previous diagnosis of cancer with the exception of non-melanoma skin cancer and in situ cancer of the cervix
* Currently using oral 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 thrombo-embolic disease such as embolies, deep vein thrombosis, stroke, TIA or cardiac arrest.
* Known APC (Activated protein C )- resistance, an inherited hemostatic disorder
* A history of major surgery of the breast, e.g. reduction or enlargement, which might affect density measurement…