# US 10,765,684 B2 · Reduction of side effects from aromatase inhibitors used for treating breast cancer

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- Number: US 10,765,684 B2
- Document ID: US10765684B2
- Status: Granted
- Kind: B2
- Application number: 15/990,316
- Filed: 2018-05-25
- Published: 2019-05-02
- Granted: 2020-09-08
- Earliest claimed: 2005-10-19
- Assignees: Havah Therapeutics Pty Ltd.
- Applicants: Havah Therapeutics Pty Ltd
- Inventors: Stephen Nigel Birrell
- Web page: https://patentgrep.com/patent/US10765684B2

## CPC

- A61K 31/568: substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/20: Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)}
- A61K 31/4196: 1,2,4-Triazoles
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/08: for nausea, cinetosis or vertigo; Antiemetics
- A61P 1/12: Antidiarrhoeals
- A61P 1/14: Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/06: Antihyperlipidemics
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/08: Vasodilators for multiple indications
- A61P 9/12: Antihypertensives
- A61P 11/04: for throat disorders
- A61P 11/14: Antitussive agents
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 15/10: for impotence
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61P 19/10: for osteoporosis
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61P 25/20: Hypnotics; Sedatives
- A61P 25/22: Anxiolytics
- A61P 25/24: Antidepressants
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 35/00: Antineoplastic agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention is directed generally to pharmaceutical compositions, methods, and kits for improving side effects associated with aromatase inhibitor treatment in a subject diagnosed with breast cancer. More specifically, the present invention provides compositions, methods, and kits comprising an aromatase inhibitor and an androgenic agent.

## Claims

### Claim 1

A method of mitigating one or more side effects in a postmenopausal patient being treated for breast cancer, comprising administering to said patient:
a) 30-50 mg per day of testosterone or testosterone undecanoate; and
b) an effective amount per day of an aromatase inhibitor; wherein the mitigated one or more side effects comprises urinary tract infection or breast pain.

### Claim 2 (depends on 1)

The method of claim 1, wherein the testosterone or testosterone undecanoate is administered orally.

### Claim 3 (depends on 1)

The method of claim 1, wherein the testosterone is administered in tablet form.

### Claim 4 (depends on 3)

The method of claim 3, wherein the tablet is administered once a day.

### Claim 5 (depends on 1)

The method of claim 1, wherein 30 mg per day of testosterone is administered.

### Claim 6 (depends on 1)

The method of claim 1, wherein 40 mg per day of testosterone undecanoate is administered.

### Claim 7 (depends on 1)

The method of claim 1, wherein 35 mg per day of testosterone is administered.

### Claim 8 (depends on 1)

The method of claim 1, wherein the aromatase inhibitor is anastrozole.

### Claim 9 (depends on 8)

The method of claim 8, wherein the effective amount of the anastrozole is about 1 mg per day.

### Claim 10 (depends on 8)

The method of claim 8, wherein the anastrozole is administered orally.

### Claim 11 (depends on 8)

The method of claim 8, wherein the anastrozole is administered in tablet form.

### Claim 12 (depends on 11)

The method of claim 11, wherein the tablet is administered once a day.

### Claim 13 (depends on 8)

The method of claim 8, wherein 30 mg per day of testosterone is orally administered and 1 mg per day of the anastrozole is orally administered.

### Claim 14 (depends on 1)

The method of claim 1, wherein the aromatase inhibitor treatment is an adjuvant therapy treatment to said patient already having received chemotherapy.

### Claim 15 (depends on 13)

The method of claim 13, wherein the aromatase inhibitor treatment is an adjuvant therapy treatment to said patient already having received chemotherapy.

### Claim 16 (depends on 13)

The method of claim 13, wherein the aromatase inhibitor treatment is an adjuvant therapy treatment to said patient already having received chemotherapy.

### Claim 17 (depends on 4)

The method of claim 4, wherein 30 mg per day of testosterone is administered.

### Claim 18 (depends on 13)

The method of claim 13, wherein the anastrozole is administered in tablet form.

### Claim 19 (depends on 18)

The method of claim 18, wherein the tablet is administered once a day.