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

• US 9,351,977 B2
• Filed: 10/22/2015
• Issued: 05/31/2016
• Est. Priority Date: 10/22/2014
• Status: Active Grant

• Current Assignee: Havah Therapeutics Pty., Ltd.
• Original Assignee: Chavah Pty Ltd.
• Inventors: Birrell, Stephen Nigel
• Primary Examiner(s): CHANDRAKUMAR, NIZAL S
• Application Number:
  US14/920,192
• Publication Number:
  US 20160113947A1
• Time in Patent Office: 222 Days
• Field of Search: 514/171
• US Class Current: 1/1
• 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 a subcutaneous implant comprising:

i) an effective amount of testosterone; and

ii) 0.1-4 mg of anastrozole.

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

3. The method of claim 1, wherein the patient'"'"'s breast has a mammographic breast density of 25% or greater.

4. The method of claim 1, wherein the method enhances, increases, or improves, mammographic visualization or detection of the breast.

5. The method of claim 1, wherein the method enhances, increases, or improves, breast compression during mammographic visualization or detection of the breast.

6. The method of claim 1, wherein the method enhances, increases, or improves, the treated patient'"'"'s compliance of having regular mammographic visualizations or detections.

7. The method of claim 1, wherein the subcutaneous implant comprises:

i) 50-150 mg of the testosterone; and

ii) 1 mg, 2 mg, or 3 mg of the anastrozole.

8. The method of claim 7, wherein the patient is premenopausal.

9. The method of claim 7, wherein the patient is peri-menopausal.

10. The method of claim 7, wherein the patient is post-menopausal.

11. The method of claim 7, wherein the patient'"'"'s breast has a BIRADS score of 3 or 4 (or c or d).

12. The method of claim 7, wherein the patient'"'"'s breast has a mammographic breast density of 7.5% or greater.

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

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