Methods of reducing mammographic breast density and/or breast cancer risk
Inventors
Assignees
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Publication Number
US-11040044-B2
Publication Date
2021-06-22
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-memopausal 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 treatment of a patient involving administration of an androgenic agent together with an aromatase inhibitor. The androgenic agent is testosterone, and the aromatase inhibitor blocks conversion of the androgenic agent into an estrogen by aromatase enzyme.
The stated purpose includes stabilizing and/or increasing androgen receptor expression level in breast tissue of at least one breast, and/or reducing the risk of perturbation of the hypothalamic-pituitary axis or pituitary gland function. The disclosed approach is used in treatment to address mammographic breast density and breast stiffness associated with an increased risk of developing breast cancer.
The partial content further indicates that endocrine effects are monitored with serum biomarkers including FSH and LH. It also describes documented biological and imaging-related effects associated with the combined administration, including reduced mammographic breast density measures and improved mammographic and MRI visualization metrics.
Claims Coverage
The partial content provides three independent methods involving testosterone in combination with an aromatase inhibitor that blocks conversion into estrogen. Across these independent claims, the core inventive features cover stabilizing and/or increasing androgen receptor expression in breast tissue, reducing risk of perturbation of the hypothalamic-pituitary axis or pituitary gland function, and addressing levels of mammographic breast density and/or breast stiffness associated with increased breast cancer risk.
Stabilizing and/or increasing androgen receptor expression in breast tissue with testosterone plus aromatase inhibitor
A method for stabilizing and/or increasing androgen receptor expression level in breast tissue of at least one breast of a patient, by administering an effective amount of testosterone in combination with an effective amount of an aromatase inhibitor, wherein the aromatase inhibitor blocks conversion of the androgenic agent into an estrogen by aromatase enzyme.
Reducing risk of perturbation of the hypothalamic-pituitary axis with testosterone plus aromatase inhibitor
A method for reducing the risk of perturbation of the hypothalamic-pituitary axis in treatment of a patient involving administration of testosterone in combination with an aromatase inhibitor, wherein the aromatase inhibitor blocks conversion of the androgenic agent into an estrogen by aromatase enzyme.
Reducing risk of perturbation of pituitary gland function associated with mammographic breast density and/or breast stiffness
A method for reducing the risk of perturbation of pituitary gland function in the treatment of a patient for a level of mammographic breast density and/or breast stiffness associated with an increased risk of developing breast cancer, comprising administering to the patient testosterone in combination with an aromatase inhibitor, wherein the aromatase inhibitor blocks conversion of the androgenic agent into an estrogen by aromatase enzyme.
All independent claims center on combined administration of testosterone with an aromatase inhibitor that blocks conversion of the androgenic agent into estrogen by aromatase enzyme, to stabilize and/or increase androgen receptor expression in breast tissue and to reduce risk of hypothalamic-pituitary axis or pituitary gland function perturbation, including contexts tied to mammographic breast density and/or breast stiffness associated with increased breast cancer risk.
Stated Advantages
Stabilizing and/or increasing androgen receptor expression level in breast tissue.
Reducing the risk of perturbation of the hypothalamic-pituitary axis.
Reducing risk of perturbation of pituitary gland function.
Reducing the risk associated with mammographic breast density and/or breast stiffness that is associated with an increased risk of developing breast cancer.
Reducing the patient’s risk of developing breast cancer.
Reducing mammographic breast density and/or breast stiffness, including improvements reflected in VBD%, AVBD, ABD%, and BI-RADS categories.
Reducing breast pain and macromastia and decreasing breast elasticity/mechano-transduction concepts.
Inducing breast involution/net cell death over proliferation and lowering extracellular matrix degradation concepts.
Documented Applications
Treatment of a patient involving combined administration of testosterone with an aromatase inhibitor, used to stabilize and/or increase androgen receptor expression level in breast tissue and/or reduce risk of perturbation of the hypothalamic-pituitary axis.
Treatment context for levels of mammographic breast density and/or breast stiffness associated with an increased risk of developing breast cancer, where combined testosterone plus aromatase inhibitor is used to reduce risk of pituitary gland function perturbation.
Treatment to reduce the patient’s risk of developing breast cancer.
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