To evaluate the impact of a selective androgen receptor modulator combined with an aromatase inhibitor in reducing high mammographic breast density.
High mammographic breast density is a well recognized risk factor for the development of breast cancer and the masking of malignancy within the breast. Previous chemoprevention studies have revealed that only tamoxifen is efficacious in premenopausal women in the reduction of breast cancer. In order for this to occur mammographic density has to be reduced. Unfortunately the side effect profile of tamoxifen is such that not many women are taking up this therapeutic intervention. This trial is trying to establish a combination therapy to reduce mammographic breast density. This phase 1 pilot study is combining oral enobosarm, a selective androgen receptor modulator, and oral anastrozole, an aromatase inhibitor, to study the impact of this combination treatment on mammographic breast density and breast elasticity. Safety and tolerability we also analyzed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Oral combination therapy of enobosarm and anastrozole
Wellend Health
Toorak Gardens, South Australia, Australia
Mammographic breast density
Volumetric analysis of fibroglandular density change on mammography utilizing Volpara software
Time frame: 12 months
Breast tissue elasticity
Evaluation of breast elasticity change by direct shear wave ultrasonic measurement
Time frame: 1 month
Breast tissue elasticity
Evaluation of breast elasticity change by direct shear wave ultrasonic measurement
Time frame: 3 months
Breast tissue elasticity
Evaluation of breast elasticity change by direct shear wave ultrasonic measurement
Time frame: 6 months
Breast pain scale
Breast pain measured on a 100 mm visual analog scale
Time frame: 1 month, 3 months, 12 months
Serum gonadotropin levels
serum follicular stimulating hormone and luteinizing hormone levels
Time frame: 1 month, 3 months, 12 months
Menopausal symptoms
Menopause symptoms as recorded on a menopause symptoms scale
Time frame: 3 months, 12 months
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