Methods of reducing mammographic breast density and/or breast cancer risk
Inventors
Assignees
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Publication Number
US-10471073-B2
Publication Date
2019-11-12
Expiration Date
Abstract
The present disclosure is directed to generally methods and/or compositions for treating mammographic breast density and/or breast stiffness in a patient in need thereof, such as a pre-menopausal, a peri-menopausal or a post-menopausal patient, comprising the administration of an effective amount of androgenic agent and an effective amount of an aromatase inhibitor. The present disclosure is also directed to methods and/or compositions for reducing breast pain. The present disclosure is also directed to method and/or compositions for reducing elasticity and/or decreasing mechano-transduction on the genome of breast cells. The present disclosure is also directed to methods and/or compositions for stabilizing and/or increasing the levels of androgen receptor expression in breast tissue.
Core Innovation
The invention relates to reducing mammographic breast density and/or breast stiffness in a patient by administering an effective amount of a selective androgen receptor modulator together with an effective amount of an aromatase inhibitor. The approach targets pathologically high mammographic breast density, including VBD%, AVBD, and ABD%, and/or breast stiffness in pre-, peri-, and post-menopausal patients using co-administration of androgenic agents and aromatase inhibitors.
The disclosure describes mammographic breast density outcomes and physical and tissue property measures, including reductions in mammographic breast density, absolute volumetric breast density (AVBD), volumetric/areal breast density percent (VBD%), and density categories such as BIRADS. It also states that the treatment reduces breast pain and breast stiffness and changes tissue composition and biological processes.
The disclosure further states that the co-administration improves mammographic sensitivity and reduces unnecessary further work-up by lowering false positives, and it also reduces MRI breast image background parenchymal enhancement while improving detection of abnormalities. It additionally describes changes in tissue composition such as increased fat-to-breast tissue ratio and reductions in cyst size and/or quantity, together with biomarker changes including increased CD36 and androgen receptor expression and altered GCDFP15.
Claims Coverage
The patent includes one independent method claim. The independent claim covers co-administration of a selective androgen receptor modulator with an aromatase inhibitor to reduce mammographic breast density and/or breast stiffness in a patient.
Co-administering a selective androgen receptor modulator with an aromatase inhibitor for density and stiffness reduction
Administering an effective amount of a selective androgen receptor modulator together with an effective amount of an aromatase inhibitor.
The core coverage is defined by the combined administration of a selective androgen receptor modulator and an aromatase inhibitor to reduce mammographic breast density and/or breast stiffness.
Stated Advantages
Reduces mammographic breast density and/or breast stiffness.
Reduces breast pain and breast stiffness.
Improves mammographic sensitivity and reduces false positives and unnecessary further work-up.
Reduces MRI breast image background parenchymal enhancement and improves detection of abnormalities.
Increases fat-to-breast tissue ratio and changes tissue composition and biomarkers, including CD36, androgen receptor expression, and GCDFP15.
Reduces breast cyst size and/or quantity.
Documented Applications
A method for reducing mammographic breast density and/or breast stiffness in a patient by co-administering a selective androgen receptor modulator and an aromatase inhibitor.
Treating pathologically high mammographic breast density, including VBD%, AVBD, and ABD%, and/or breast stiffness in pre-, peri-, and post-menopausal patients by co-administering a selective androgen receptor modulator and an aromatase inhibitor.
Monitoring therapy effects using mammographic density measures, stiffness, pain, fat-to-breast tissue ratio, biological markers such as CD36, androgen receptor, and GCDFP15, and imaging endpoints such as MRI background parenchymal enhancement, as well as assessment of breast cyst size and/or quantity.
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