IP Library Granted Patent US 11,883,414
Granted Patent B2
US 11,883,414 · App. 17/344,052 · Granted Jan 30, 2024

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

Inventor: Stephen Nigel Birrell (Picadilly, AU)
Assignee: Havah Therapeutics Pty Ltd.
A61K31/568A61K9/0024A61K9/0053A61K31/4196A61K31/569A61K45/06
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Quick Facts
Patent No.
US 11,883,414
App. No.
17/344,052
Granted
Jan 30, 2024
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 (14)

1. 1 . A method of reducing background parenchymal enhancement (BPE) 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 2 , 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 the method improves breast compression during mammographic visualization or detection of the breast between one or more annual intervening mammographic detections.

5. The method of claim 3 , 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.

6. The method of claim 3 , wherein the patient is pre-menopausal.

7. The method of claim 3 , wherein the patient is peri-menopausal.

8. The method of claim 3 , wherein the BPE reduces by at least 1 Breast Imaging-Reporting and Data System (BI-RADS®) level after 1 year, 2 years, 3 years, 4 years or 5 years of treatment.

9. The method of claim 8 , wherein the BPE reduces by at least 2 BI-RADS® levels after 1 year, 2 years, 3 years, 4 years or 5 years of treatment.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 27, 2021
From: BIRRELL, STEPHEN NIGEL
To: HAVAH THERAPEUTICS PTY LTD.
Reel/Frame 056983/0673 →
Continuity (5)
Continuation 16704535 · Dec 5, 2019
Continuation 16055588 · Aug 6, 2018
Continuation 15520278
Provisional Application 62067297 · Oct 22, 2014
Related Publication 20220079954A1 · Mar 17, 2022
Cited By (1)
US 12,383,563