Methods of reducing mammographic breast density and/or breast cancer risk
Inventors
Assignees
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Publication Number
US-10064874-B2
Publication Date
2018-09-04
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 describes methods and pharmaceutical formulations that combine an androgenic agent with an aromatase inhibitor for treating a patient. The androgenic agent is selected from testosterone, methyltestosterone, testosterone undecanoate, testosterone propionate, testosterone cypionate, and testosterone enanthate, and the aromatase inhibitor is selected from exemestane, anastrozole, letrozole, formestane, vorozole, and fadrozole.
The disclosed approach includes administering the agents in a single combined formulation or administering them separately while concurrently or sequentially dosing the patient. The method is directed to reducing breast pain while mitigating the treated patients risk of developing breast cancer.
The disclosure also includes breast density, breast stiffness, and breast pain measurements, with imaging-based measures such as mammographic breast density metrics and MRI background parenchymal enhancement. It describes associations with reductions in interval breast cancer risk, false-positive recalls, and changes in breast stiffness and pain measures.
Claims Coverage
The independent claim covers one inventive feature: combined administration of an androgenic agent and an aromatase inhibitor for reducing breast pain while mitigating risk of developing breast cancer.
Reducing breast pain with paired androgenic agent and aromatase inhibitor to mitigate breast cancer risk
Administering to a patient an effective amount of an androgenic agent selected from testosterone, methyltestosterone, testosterone undecanoate, testosterone propionate, testosterone cypionate, and testosterone enanthate, together with an effective amount of an aromatase inhibitor selected from exemestane, formestane, anastrozole, letrozole, vorozole, and fadrozole, wherein the method mitigates the treated patients risk of developing breast cancer.
The claim set centers on the combined administration of a specified androgenic agent with a specified aromatase inhibitor for reducing breast pain and mitigating risk of developing breast cancer.
Stated Advantages
Reduces breast pain.
Mitigates the treated patients risk of developing breast cancer.
Improves mammographic sensitivity.
Reduces false-positive recalls.
Reduces interval breast cancer risk.
Improves compliance.
Minimizes peri-/post-menopausal side effects.
Documented Applications
Treatment of mammographic breast density, breast stiffness, and breast pain in pre-, peri-, and post-menopausal patients, with mitigation of breast cancer risk.
Use in mammography contexts with BI-RADS/density thresholds and reduction of false-positive recalls and interval breast cancer risk.
A method for reducing breast pain in a patient in need thereof while mitigating the patients risk of developing breast cancer.
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