IP Library Granted Patent US 10,525,063
Granted Patent B2
US 10,525,063 · App. 16/055,588 · Granted Jan 7, 2020

Methods of reducing mammographic breast density and/or breast cancer risk

Inventor: Stephen Nigel Birrell (Piccadilly, AU)
Assignee: Havah Therapeutics Pty Ltd.
A61K31/568A61K9/0024A61K9/0053A61K31/4196A61K31/569A61K45/06
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Quick Facts
Patent No.
US 10,525,063
App. No.
16/055,588
Granted
Jan 7, 2020
Kind
B2
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.

Claims (27)

1. A method of reducing breast density 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 effective amount of androgenic agent is testosterone and the effective amount of the aromatase inhibitor is anastrozole and is administered by subcutaneous implant.

3. The method of claim 1 , 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.

4. The method of claim 3 , 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.

5. The method of claim 4 , wherein the method improves breast compression during mammographic visualization or detection of the breast between one or more annual intervening mammographic detections.

6. The method of claim 4 , 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.

7. The method of claim 4 , wherein the patient is pre-menopausal.

8. The method of claim 4 , wherein the patient is peri-menopausal.

9. The method of claim 4 , wherein the patient has, or is diagnosed with having, a breast with an area breast density percentage (ABD %) of 7.5% or greater.

10. The method of claim 9 , wherein the method reduces the ABD % or an 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.

11. The method of claim 4 , wherein the patient has, or is diagnosed with having, a breast with a volume breast density percentage (VBD %) of 7.5% or greater.

12. The method of claim 11 , wherein the method reduces the VBD % or an 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.

13. The method of claim 1 , wherein the method improves breast compression during mammographic visualization or detection of the breast between one or more annual intervening mammographic detections.

14. 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.

15. The method of claim 1 , wherein the patient is pre-menopausal.

16. The method of claim 1 , wherein the patient is peri-menopausal.

17. 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.

18. The method of claim 17 , wherein the method reduces the ABD % or an 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.

19. 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.

20. The method of claim 19 , wherein the method reduces the VBD % or an 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.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 4, 2021
From: BIRRELL, STEPHEN NIGEL
To: HAVAH THERAPEUTICS PTY LTD.
Reel/Frame 056133/0950 →
Continuity (3)
Continuation 15520278
Provisional Application 62067297 · Oct 22, 2014
Related Publication 20190167697A1 · Jun 6, 2019
Cited By (1)
US 12,383,563