Status:
COMPLETED
Karolinska Interventional Study of Mammograhic Density (Karisma-1)
Lead Sponsor:
Karolinska Institutet
Conditions:
Breast Cancer
Mammographic Density
Eligibility:
FEMALE
40-74 years
Phase:
PHASE1
PHASE2
Brief 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 chan...
Detailed Description
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04079517
Start Date
March 1 2015
End Date
March 1 2016
Last Update
February 6 2025
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