Methods of reducing mammographic breast density and/or breast cancer risk
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.
1. A method of reducing breast pain in a patient in need thereof, comprising administering to the patient:
i) an effective amount of androgenic agent selected from the group consisting of testosterone, methyltestosterone, testosterone undecanoate, testosterone propionate, testosterone cypionate, and testosterone enanthate; and
ii) an effective amount of an aromatase inhibitor selected from the group consisting of: exemestane, formestane, anastrozole, letrozole, vorozole, and fadrozole;
wherein the method mitigates the treated patient's risk of developing breast cancer.
2. The method of claim 1 , wherein the method mitigates or reduces breast stiffness in the patient's breast by at least 5% over a 2 week, 1 month, 2 month, 3 month, 6 month, 9 month, 1 year period, or 5 year period.
3. The method of claim 1 , wherein the method reduces the treated patient's risk of developing breast cancer.
4. The method of claim 1 , wherein the method reduces breast pain in at least one of the patient's breasts.
5. The method of claim 1 , wherein the method reduces the patient's breast pain:
i) associated with having a mammography image taken; and/or
ii) in at least one of the patient's breasts between one or more annual intervening mammographic detections.
6. The method of claim 1 , wherein the method:
i) mitigates or reduces the patient's pain during breast compression; and/or
ii) improves breast compression during mammographic visualization or detection of the breast between one or more annual intervening mammographic detections.
7. The method of claim 1 , wherein the method mitigates or reduces the patient's pain according to the visual analog scale (VAS) during breast compression.
8. The method of claim 1 , wherein the method reduces and/or treats macromastia in at least one of the patient's breasts between one or more annual intervening mammographic detections.
9. The method of claim 1 , wherein the method reduces breast inflammation.
10. The method of claim 1 , wherein the method increases or improves the patient's fat to breast tissue ratio from 1:19 to 19:1 over a 3 month period, over a 6 month period, over a 9 month period, over a 1 year period, or over a 5 year period.
11. The method of claim 1 , wherein the method stabilizes and/or increases levels of androgen receptor expression in breast tissue in at least one of the patient's breasts between one or more annual intervening mammographic detections.
12. The method of claim 1 , wherein the method reduces or reverses peri-menopausal symptoms.
13. The method of claim 1 , wherein the androgen agent is testosterone and the aromatase inhibitor is anastrozole.
14. The method of claim 13 , wherein the testosterone is administered by subcutaneous implant.
15. The method of claim 13 , wherein:
i) the effective amount of the testosterone is 2-200 mg; and
ii) the effective amount of the anastrozole is 0.5-10 mg.
16. The method of claim 15 , wherein the testosterone is administered by subcutaneous implant.
17. The method of claim 1 , wherein the patient is pre-menopausal.
18. The method of claim 1 , wherein the patient is peri-menopausal.
19. The method of claim 1 , wherein the patient is post-menopausal.
20. The method of claim 1 , wherein the patient has, or is diagnosed with having, a breast with a mammographic breast density of 7.5% or greater.
21. The method of claim 1 , wherein the patient has, or is diagnosed with having, a breast with an area breast density percentage (ABD %) of 7.5% or greater.
22. The method of claim 21 , wherein the method reduces the ABD % or absolute area breast density (AABD) of the patient's breast by at least 2% over a 2 week, 1 month, 2 month, 3 month, 6 month, 9 month, or 1 year period.
23. The method of claim 1 , wherein the patient has, or is diagnosed with having, a breast with a volume breast density percentage (VBD %) of 7.5% or greater.
24. The method of claim 23 , wherein the method reduces the VBD % or absolute volume breast density (AVBD) of the patient's breast by at least 2% over a 2 week, 1 month, 2 month, 3 month, 6 month, 9 month, or 1 year period.
25. The method of claim 1 , wherein the patient has, or is diagnosed with having, a breast with a BIRADS score of 3 or 4 (or c or d).
26. The method of claim 1 , wherein the method provides a reduction in macromastia or reduces breast inflammation associated with macromastia.
27. The method of claim 1 , wherein the method provides a reduction in breast cysts or reduces breast inflammation associated with breast cysts.
28. The method of claim 1 , wherein the method provides a reduction in breast elasticity.