Low Dose Tamoxifen for Mammographic Density Reduction

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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

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Risk Reduction Mammographic Density Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Randomised dose of tamoxifen 1 pill/day for 180 days

Intervention Type DRUG

Placebo Oral Tablet

Randomised dose of tamoxifen 1 pill/day for 180 days

Intervention Type DRUG

Eligibility Criteria

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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 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes