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

• US 10,155,005 B2
• Filed: 03/16/2017
• Issued: 12/18/2018
• Est. Priority Date: 10/22/2014
• Status: Active Grant

• Current Assignee: Havah Therapeutics Pty., Ltd.
• Original Assignee: Havah Therapeutics Pty., Ltd.
• Inventors: Birrell, Stephen Nigel
• Primary Examiner(s): Chandrakumar, Nizal S
• Application Number:
  US15/460,895
• Publication Number:
  US 20170246185A1
• Time in Patent Office: 642 Days
• Field of Search: 514171
• CPC Class Codes: A61K 31/4196 1,2,4-Triazoles
• CPC Class Codes: A61K 31/568 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
• CPC Class Codes: A61K 31/569 substituted in position 17 alpha, e.g. ethisterone
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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.

Claims

1. A method of treating mammographic breast density and/or breast stiffness in a patient in need thereof, comprising administering to the patient:

i) an effective amount of an androgenic agent selected from the group consisting of;

testosterone, methyltestosterone, enanthate testosterone, propionate testosterone, cypionate testosterone, and undecanoate testosterone; and

ii) 0.1-10 mg of anastrozole;

wherein the method mitigates or reduces the treated patient'"'"'s risk of developing breast cancer.

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

3. The method of claim 1, wherein the patient is premenopausal.

4. The method of claim 1, wherein the patient'"'"'s breast has a mammographic breast density of 25% or greater via 2-D determination.

5. The method of claim 1, wherein the patient'"'"'s breast has a BIRADS score of 3 or 4 (or c or d).

6. The method of claim 1, wherein the patient'"'"'s breast has a mammographic breast density of 7.5% or greater via 3-D determination.

7. The method of claim 1, wherein the method reduces or decreases the mammographic breast density of the patient'"'"'s breast between one or more annual intervening mammographic detections.

8. The method of claim 1, wherein the method reduces or decreases the breast stiffness of the patient'"'"'s breast between one or more annual intervening mammographic detections.

9. The method of claim 1, wherein the method reduces or decreases the patient'"'"'s pain during breast compression.

10. The method of claim 1, wherein the method reduces or minimizes the patient'"'"'s BIRADS score by 1 or more points between one or more annual intervening mammographic detections.

11. The method of claim 1, wherein the method enhances, increases, or improves, one or more of the following:

i) mammographic visualization or detection of the patient'"'"'s breast;

ii) breast compression during mammographic visualization or detection of the patient'"'"'s breast;

iii) the treated patient'"'"'s compliance of having regular mammographic visualizations or detections;

or

iv) combinations thereof.

12. The method of claim 1, wherein the anastrozole is administered to the patient orally, transdermally or via a subcutaneous implant.

13. The method of claim 1, wherein the anastrozole is administered in an amount of 1 mg, 2 mg, 3 mg, 4 mg, 5 mg, or 6 mg.

14. The method of claim 1, wherein the androgenic agent is administered to the patient via a subcutaneous implant, injection, transdermally, or by intramuscular administration.

15. The method of claim 14, wherein the androgenic agent is testosterone.

16. The method of claim 15, wherein the effective amount of the testosterone is in the range of between 30-150 mg.

17. The method of claim 1, wherein the androgenic agent is enanthate testosterone, propionate testosterone, cypionate testosterone, or undecanoate testosterone.

18. The method of claim 1, wherein the androgenic agent is methyltestosterone.

19. The method of claim 1, wherein the patient is post-menopausal.