A randomized, open pilot study to investigate the mammographic density reduction in healthy women ,within the Karma cohort, for two different doses of tamoxifen.
Conditions
Interventions
Trade Name: Tamoxifen Mylan
Pharmaceutical Form: Tablet
INN or Proposed INN: TAMOXIFEN
CAS Number: 10540-29-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
T
Sponsors
Karolinska Institute
Eligibility
Sex/Gender
All
Inclusion criteria
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 1/3. •Informed signed consent must be signed before any study specific assessments have been collectedperformed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: •Being pregnant or planning to become pregnant during the study •Any previous or current diagnosis of breast cancer (including carcinoma in situ) •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 trombo-embolic disease such as embolies, 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To identify time to mammographic density change in healthy women using two different doses of tamoxifen;Secondary Objective: Secondary objectives: To evaluate the effect on mammographic density of 10 mg of tamoxifen;Primary end point(s): Change in mammographic density at 3, 6 and 12 months following start of two different tamoxifen doses therapy;Timepoint(s) of evaluation of this end point: 3, 6 and 12 months following start of two different tamoxifen doses therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: Change in mammographic density at 3, 6 and 12 months after start of 10 mg tamoxifen;Timepoint(s) of evaluation of this end point: Change in mammographic density at 3, 6 and 12 months after start of 10 mg tamoxifen | — |
Countries
Sweden
Contacts
Public ContactKarma Study Center
Södersjukhuset
Outcome results
None listed