The mammographic density reduction in healthy women.
Conditions
Interventions
Product Name: Endoxifen
Pharmaceutical Form: Cutaneous liquid
Pharmaceutical form of the placebo: Cutaneous liquid
Route of administration of the placeb
Sponsors
Atossa Genetics Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Participant in the Karma Cohort •Attending the national mammography screening program, i.e., aged 40-74 and have performed a screening mammogram maximum 3 months prior to study inclusion •Mammographic density =4.5 % density (volumetric) measured by Volpara, at the screening mammogram performed in connection to baseline (maximum 3 months prior to inclusion). The threshold value of 4.5% corresponds to the clinically used BI-RADS score A •Postmenopausal, defined as no period of menstruation during last 12 months independent of any hormonal treatment •Informed consent must be signed before any study specific assessments are performed 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Criteria related to study design •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 •A history of major surgery of the breast, e.g., reduction or enlargement, which might affect density measurements •Mammographic BI-RADS malignancy code 3, or above, at baseline mammography, or at mammography during time of treatment. Recall for additional examinations due to technical problems with the mammogram is accepted. •Currently using oestrogen and progesterone based hormone replacement therapy (oral or patches). Local treatment accepted (ex. Vagifem) •Non-medical approved drugs against hot-flashes including phytooestrogen Criteria related to safety •A history of thromboembolic disease such as embolies, deep vein thrombosis, stroke, TIA or myocardial infarction. •Known APC (Activated Protein C)-resistance, an inherited hemostatic disorder •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 Waran (warfarin) or other anti-coagulantsPrescribed and regular use of anticoagulants (defined as substances included in group B01A in the ATC-system) •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: To determine the effect size of breast density between topical placebo and two doses of topical endoxifen. The effect size will permit sample size calculations for statistical significance in a future phase III trial.;Secondary Objective: Assess tolerability and safety of topical endoxifen;Primary end point(s): Primary endpoint is to determine change, on an individual level, in mammographic breast density, measured at 3 and 6 months after study entry (= baseline screening mammography).;Timepoint(s) of evaluation of this end point: 3 and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 3 and 6 months.; Secondary end point(s): Determine dose dependent differences in compliance, side effects and local tolerability measured through questionnaires Determine dose dependent differences in laboratory assessments such as liver function tests (ALAT, ASAT, ALP, Bilirubin), coagulation function (INR, aPTT), sex hormone binding globulin (SHBG) | — |
Countries
Sweden
Contacts
Public ContactJanet Rea, VP Reg., Quality&Clin.
Atossa Genetics Inc
Outcome results
None listed