Status:
COMPLETED
Low Dose Tamoxifen for Mammographic Density Reduction
Lead Sponsor:
Per Hall
Conditions:
Risk Reduction
Mammographic Density Reduction
Eligibility:
FEMALE
40-74 years
Phase:
PHASE2
Brief 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...
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. I...
Eligibility Criteria
Inclusion
- 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
- 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 measurements
- Women who have an increased risk of venous thrombosis due to immobilization, e.g. using wheelchair
- Known uncontrolled 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 Seroxat (paroxetine), Fontex (fluoxetin) and Zyban / Voxra (bupropion)
- Use of Waran (warfarin)
- Non-medical approved drugs against hot-flashes including phytooestrogen
- Not able to understand study information and/or informed consent
Key Trial Info
Start Date :
November 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
1440 Patients enrolled
Trial Details
Trial ID
NCT03346200
Start Date
November 1 2016
End Date
December 1 2019
Last Update
March 7 2025
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