Methods of reducing mammographic breast density and/or breast cancer risk
Inventors
Assignees
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Publication Number
US-10155005-B2
Publication Date
2018-12-18
Expiration Date
Abstract
The present disclosure is directed to generally methods for treating mammographic breast density and/or breast stiffness in a patient in need thereof, such as a premenopausal or perimenopausal patient, comprising the administration of an effective amount of androgenic agent and an effective amount of an aromatase inhibitor. These methods may also be useful in post-menopausal woman.
Core Innovation
The invention relates to a method of treating mammographic breast density and/or breast stiffness in a patient in need thereof by administering an androgenic agent together with anastrozole. The approach is directed to mitigating or reducing the treated patient's risk of developing breast cancer. The method specifies an androgenic agent selected from testosterone, methyltestosterone, enanthate testosterone, propionate testosterone, cypionate testosterone, and undecanoate testosterone.
The invention addresses breast tissue properties described as mammographic breast density and breast stiffness, and ties treatment to breast cancer risk mitigation. The disclosed framework encompasses administering the androgenic agent and anastrozole as part of a treating method, with anastrozole administered in an amount of 0.1-10 mg. The patent also frames dosing concepts using patient characterization parameters such as mammographic breast density and breast stiffness, together with aromatase inhibitor and androgen indices as described in the disclosure.
The document further describes ways to assess mammographic breast density using 2-D or 3-D determination and to assess imaging/composition categories, including BIRADS-based categorization. In addition, the disclosure describes anticipated clinical and imaging effects such as involution and net cell death over proliferation, together with changes in extracellular matrix degradation and measures of breast compression and pain.
Claims Coverage
The independent claim coverage includes 1 independent claim (clm-00001). Across the dependent claims described in the provided material, the inventive features mainly refine patient eligibility and treatment endpoints for mammographic breast density and related imaging measures, and narrow anastrozole and androgen selections or dosage ranges.
Androgenic agent with anastrozole for risk mitigation
Administering to a patient in need thereof an effective amount of an androgenic agent selected from testosterone, methyltestosterone, enanthate testosterone, propionate testosterone, cypionate testosterone, and undecanoate testosterone, and administering 0.1-10 mg of anastrozole, wherein the method mitigates or reduces the treated patient's risk of developing breast cancer.
BIRADS score reduction over annual mammographic detections
The method reduces or minimizes a patient's BIRADS score by at least 1 point between one or more annual mammographic detections.
2-D mammographic breast density threshold
Determining that a patient’s breast has a mammographic breast density of at least 25% using a 2-D determination.
3-D mammographic breast density threshold
Determining the patient’s breast mammographic breast density as at least 7.5% using 3-D determination.
Anastrozole route selection
Administering anastrozole to the patient orally, transdermally, or via a subcutaneous implant.
Testosterone effective amount range
The method further requires that the effective amount of testosterone is within the range of 30 to 150 mg.
Overall claim coverage centers on the co-administration of a specified androgenic agent with anastrozole to treat mammographic breast density and/or breast stiffness while mitigating breast cancer risk. The dependent claim refinements focus on imaging-based eligibility and response metrics (BIRADS and mammographic density thresholds using 2-D or 3-D determination), on specifying anastrozole administration routes, and on constraining testosterone to a specified effective amount range (30 to 150 mg).
Stated Advantages
Mitigates or reduces the treated patient's risk of developing breast cancer.
Reduces or minimizes mammographic breast density.
Reduces breast stiffness.
Documented Applications
Treating mammographic breast density and/or breast stiffness in a patient in need thereof by administering an androgenic agent selected from specified testosterone forms together with anastrozole to mitigate or reduce breast cancer risk.
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