This is a randomized, double-blinded, placebo-controlled dose-response efficacy study of oral (Z)-endoxifen in premenopausal women with measurable breast density. There will be 5 in-clinic visits (Screening, Day 1, Months 1, 3 and 6) and 3 self-report visits (Months 2, 4 and 5). Standard of care mammograms will be used for the screening mammogram as well as the 24-month follow up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Z-Endoxifen
Placebo
Karma Study Centre
Stockholm, Sweden
Change of mammographic density area (cm2) assessed by iCAD® software
Change from baseline
Time frame: 6 months
Change of mammographic density area (cm2) assessed by iCAD® software
Change from baseline
Time frame: 3 months
Change of mammographic density area (cm2) assessed by Stratus software
Change from baseline
Time frame: 6 months
Change of mammographic density area (cm2) assessed by Stratus software
Change from baseline
Time frame: 3 months
Change from baseline responses to the Breast Cancer Prevention Trial Eight Symptom Scale (BESS)
5-point Likert-type scale
Time frame: 6 months
Comparison of adverse events
assessment of adverse events
Time frame: 6 months
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