Methods of reducing mammographic breast density and/or breast cancer risk
Inventors
Assignees
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Publication Number
US-10525063-B2
Publication Date
2020-01-07
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 administering an androgenic agent together with an aromatase inhibitor to reduce breast density in a patient in need thereof. 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, formestane, anastrozole, letrozole, vorozole, and fadrozole.
The disclosure describes methods and compositions combining an androgenic agent with an aromatase inhibitor to treat or prevent pathologic mammographic breast density and breast stiffness. The combined treatment is directed to pre-, peri-, and post-menopausal women and to reducing breast density and related breast mechanical characteristics, including stiffness and elasticity changes.
The combined treatment is positioned as mitigating risk of developing breast cancer and supporting favorable mammographic performance. It also describes modulation of breast tissue biomarkers and androgen-related markers, including androgen receptor expression, CD36, GCDFP15, and measurement frameworks such as VBD%, AVBD, ABD%, AABD, Boyd stiffness, MBD, and MRI background parenchymal enhancement (BPE).
Claims Coverage
The document provides one explicit independent method claim covering co-administration of a specified androgenic agent and a specified aromatase inhibitor to reduce breast density and mitigate risk of developing breast cancer. Dependent claims refine the independent claim by narrowing drug selections, specifying administration routes and dosage forms, and adding breast-density reduction thresholds and imaging-related outcomes.
Reducing breast density with combined androgenic agent and aromatase inhibitor
Administering 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, to reduce breast density and mitigate the treated patient’s risk of developing breast cancer.
Claim coverage centers on the combined administration of a specified androgenic agent with a specified aromatase inhibitor to reduce breast density while mitigating breast-cancer risk. Dependent refinements further select particular agents and routes, define dosage ranges, impose quantified breast-density reduction thresholds over follow-up periods, and add imaging- and patient-selection related limitations.
Stated Advantages
Reduces breast density in a patient in need thereof.
Mitigates the treated patient’s risk of developing breast cancer.
Reduces breast stiffness/pain.
Reduces MRI background parenchymal enhancement (BPE).
Reduces breast cysts.
Maintains endocrine safety as indicated by FSH and LH.
Improves breast compression to enhance mammographic visualization or detection of the breast between annual intervening mammographic detections.
Improves mammographic performance, including increased mammographic sensitivity and reduced false positives/interval cancer risk.
Supports breast involution and favorable cellular outcomes characterized as net cell death over proliferation.
Modulates breast tissue mechanics, including breast stiffness and related elasticity/mechano-transduction effects.
Stabilizes or increases androgen receptor expression and modulates biomarkers such as CD36 and GCDFP15.
Documented Applications
Reducing breast density using testosterone and an aromatase inhibitor in women, with monitoring of breast density metrics (MBD, VBD%, AVBD).
Breast density reduction outcomes assessed with biomarkers/endpoints including FAI and serum anastrozole levels, and imaging-related measures including MRI background parenchymal enhancement (BPE) and mammographic detection-related outcomes.
Treatment or prevention of pathologic mammographic breast density and/or breast stiffness in pre-, peri-, and post-menopausal women.
Reducing breast-cancer risk associated with breast density by combined administration of an androgenic agent and an aromatase inhibitor.
Improving imaging performance in mammography, including enhancing detection-related outcomes between annual intervening mammographic detections.
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