Methods of Reducing Mammographic Breast Density and/or Breast Cancer Risk

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.

1 - 86 . (canceled) 
     
     
         87 . A method of treating mammographic breast density and/or breast stiffness in a patient in need thereof, comprising orally administering to the patient:
 i) an effective amount of a selective androgenic receptor modulator; and   ii) 0.1-6 mg of anastrozole.   
     
     
         88 . The method of  claim 87 , wherein the selective androgenic receptor modulator is selected from the group consisting of:
 (2S)-3-(4-cyanophenoxy)-N-[4-cyano-3-(trifluoromethyl)phenyl]-2-hydroxy-2-methylpropanamide (also known as Enobosarm, Ostarine, GTx-024, and MK-2866);   (7R,7aS)-2-chloro-4-(7-hydroxy-1,3-dioxotetrahydropyrrolo[1,2-c]imidazol-2-yl)-3-methylbenzonitrile (also known as BMS-564,929);   4-((R)-2-((R)-2,2,2-trifluoro-1-hydroxyethyl)pyrrolidin-1-yl)-2-trifluoromethyl)benzonitrile (also known as LGD-4033, or Ligandrol);   4-(3-hydroxy-8-aza-bicyclo[3.2.1]octyl)-naphthalene-1-carbonitrile (also known as AC-262,356);   JNJ-28330835;   6-(bis-(2,2,2-trifluoroethyl)amino)-4-trifluoromethyl-1H-quinolin-2-one (also known as LGD-2226);   9-chloro-2-ethyl-1-methyl-3-(2,2,2-trifluoroethyl)-3H-pyrrolo[3,2-]quinolin-7(6H)-one (also known as LGD-3303);   2-[4-(dimethylamino)-6-nitro-1,2,3,4-tetrahydroquinolin-2-yl]-2-methylpropan-1-ol (also known as S-40503); or   (2S)—N-(4-cyano-3-trifluoromethylphenyl)-3-(3-fluoro-4-chlorophenoxy)-2-hydroxy-2-methyl-propanamide (also known as S-23); or   derivatives thereof.   
     
     
         89 . The method of  claim 87 , wherein the effective amount of the selective androgenic receptor modulator is in the range of between 10-120 mg. 
     
     
         90 . The method of  claim 87 , wherein the patient is peri-menopausal. 
     
     
         91 . The method of  claim 87 , wherein the patient's breast has a mammographic breast density of 25% or greater. 
     
     
         92 . The method of  claim 87 , wherein the method enhances, increases, or improves, mammographic visualization or detection of the breast. 
     
     
         93 . The method of  claim 87 , wherein the method enhances, increases, or improves, breast compression during mammographic visualization or detection of the breast. 
     
     
         94 . The method of  claim 87 , wherein the method enhances, increases, or improves, the treated patient's compliance of having regular mammographic visualizations or detections. 
     
     
         95 . The method of  claim 87 , wherein the subcutaneous implant comprises:
 i) an effective amount of a selective androgenic receptor modulator; and   ii) 1 mg, 2 mg, 3 mg, 4 mg, 5 mg, or 6 mg of the anastrozole.   
     
     
         96 . The method of  claim 95 , wherein the selective androgenic receptor modulator is selected from the group consisting of:
 (2S)-3-(4-cyanophenoxy)-N-[4-cyano-3-(trifluoromethyl)phenyl]-2-hydroxy-2-methylpropanamide (also known as Enobosarm, Ostarine, GTx-024, and MK-2866);   (7R,7aS)-2-chloro-4-(7-hydroxy-1,3-dioxotetrahydropyrrolo[1,2-c]imidazol-2-yl)-3-methylbenzonitrile (also known as BMS-564,929);   4-((R)-2-((R)-2,2,2-trifluoro-1-hydroxyethyl)pyrrolidin-1-yl)-2-trifluoromethyl)benzonitrile (also known as LGD-4033, or Ligandrol);   4-(3-hydroxy-8-aza-bicyclo[3.2.1]octyl)-naphthalene-1-carbonitrile (also known as AC-262,356);   JNJ-28330835;   6-(bis-(2,2,2-trifluoroethyl)amino)-4-trifluoromethyl-1H-quinolin-2-one (also known as LGD-2226);   9-chloro-2-ethyl-1-methyl-3-(2,2,2-trifluoroethyl)-3H-pyrrolo[3,2-f]quinolin-7(6H)-one (also known as LGD-3303);   2-[4-(dimethylamino)-6-nitro-1,2,3,4-tetrahydroquinolin-2-yl]-2-methylpropan-1-ol (also known as S-40503); or   (2S)—N-(4-cyano-3-trifluoromethylphenyl)-3-(3-fluoro-4-chlorophenoxy)-2-hydroxy-2-methyl-propanamide (also known as S-23); or   derivatives thereof.   
     
     
         97 . The method of  claim 95 , wherein the effective amount of the selective androgenic receptor modulator is in the range of between 10-120 mg. 
     
     
         98 . The method of  claim 95 , wherein the patient is premenopausal. 
     
     
         99 . The method of  claim 95 , wherein the patient is peri-menopausal. 
     
     
         100 . The method of  claim 95 , wherein the patient is post-menopausal. 
     
     
         101 . The method of  claim 95 , wherein the patient's breast has a BIRADS score of 3 or 4 (or c or d). 
     
     
         102 . The method of  claim 95 , wherein the patient's breast has a mammographic breast density of 7.5% or greater. 
     
     
         103 . The method of  claim 95 , wherein the method reduces or decreases the mammographic breast density of the patient's breast between one or more annual intervening mammographic detections. 
     
     
         104 . The method of  claim 95 , wherein the method reduces or decreases the breast stiffness of the patient's breast between one or more annual intervening mammographic detections.