Methods of reducing mammographic breast density and/or breast cancer risk
Inventors
Assignees
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Publication Number
US-11883414-B2
Publication Date
2024-01-30
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 a method of reducing background parenchymal enhancement (BPE) in a patient in need thereof. The method comprises administering to the 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. The method is directed to mitigating the treated patient’s risk of developing breast cancer.
The disclosure includes administration using pharmaceutical formulation and administration options for the combined agents. The therapy can be provided via injectable, transdermal patch, oral tablets/capsules, buccal administration, and subcutaneous pellets, including combined single-dose versus separate formulations or kits. Timing relationships between the androgenic agent and aromatase inhibitor can be concurrent or staggered, including once-daily schedules.
The disclosure also describes dosage forms and pharmaceutical formulation examples for delivering the androgenic agent and aromatase inhibitor, including tablets, capsules, emulsions including alpha-tocopherol and TPGS self-emulsifying systems, enteric coatings, and sustained or controlled release implants and transdermal patches. The described effects include reductions in BPE, including MBD/VBD/AVBD measures, reductions in breast pain and changes in breast stiffness/elasticity, endocrine safety signals via unchanged FSH/LH, mechanistic and biophysical improvements including CD36 upregulation, increased androgen receptor expression, increased GCDFP15, and improvements in MRI background parenchymal enhancement and cyst size/quantity.
Claims Coverage
The provided material includes one independent claim centered on reducing background parenchymal enhancement (BPE) by co-administering a specified androgenic agent with a specified aromatase inhibitor, with breast cancer risk mitigation as the purpose. The remaining content refines drug selection, route, biomarker and clinical effects, and quantified BPE reduction over treatment durations.
Reducing BPE by androgenic agent plus 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, and an effective amount of an aromatase inhibitor selected from exemestane, formestane, anastrozole, letrozole, vorozole, and fadrozole, wherein the method mitigates the treated patient’s risk of developing breast cancer while reducing background parenchymal enhancement (BPE).
Across the provided material, the core inventive concept is co-administration of a specified androgenic agent with a specified aromatase inhibitor to reduce BPE and mitigate risk of developing breast cancer. The content further specifies particular agent choices, route, improvements between annual mammographic detections, androgen receptor expression stabilization/increase, and quantified BI-RADS level decreases over defined treatment durations.
Stated Advantages
Reduces background parenchymal enhancement (BPE).
Mitigates the treated patient’s risk of developing breast cancer.
Improves mammographic performance, including improved mammographic sensitivity and reduced false-positive recalls.
Stabilizes and/or increases androgen receptor expression levels in breast tissue.
Decreases BPE by at least one BI-RADS level after 1 to 5 years of treatment.
Improves breast compression during mammographic visualization or detection between annual intervening mammographic detections.
Reduces breast stiffness and elasticity and reduces breast pain, including pain during compression.
Documented Applications
Use in a patient in need thereof for reducing background parenchymal enhancement (BPE).
Breast imaging and breast cancer risk mitigation by mitigating the treated patient’s risk of developing breast cancer while reducing BPE.
Application of the disclosed method to improve mammographic sensitivity and reduce false-positive recalls.
Application in patient monitoring and imaging-related functional outcomes between annual mammographic detections, including improved breast compression and quantified BPE decreases using BI-RADS level changes.
Application reporting endocrine and tissue-related effects, including stabilization/increase of androgen receptor expression levels in breast tissue and MRI background parenchymal enhancement improvements, as described in the document’s in-scope examples.
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