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Reduction of side effects from aromatase inhibitors used for treating breast cancer

A technique of aromatase inhibitor and side effects, applied in the field of androgen reagents

Inactive Publication Date: 2011-08-10
HAVAH THERAPEUTICS PTY LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, none of these androgen replacement therapy settings treat women diagnosed with breast cancer

Method used

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  • Reduction of side effects from aromatase inhibitors used for treating breast cancer
  • Reduction of side effects from aromatase inhibitors used for treating breast cancer
  • Reduction of side effects from aromatase inhibitors used for treating breast cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0152] Embodiment 1 (workability)

[0153] The following examples demonstrate the benefit of administering a pharmaceutical composition comprising an androgenic agent and aromatase to an individual diagnosed with breast cancer.

[0154] Five postmenopausal women with similar patient sociodemographic characteristics and ages 49 to 65 years (median age 54 years) were selected for the study. Each woman was diagnosed with node-negative estrogen receptor and PR (progesterone receptor) positive BCa (breast cancer) with tumor sizes ranging from 1.9 cm to 2.3 cm (median tumor size 2.1 cm) and in After selected postoperative procedures (such as mastectomy, lumpectomy, or quarter resection for primary breast cancer) and after chemotherapy. No one ever tried hormone replacement therapy.

[0155] Each woman selected received 4 weeks of aromatase inhibitor therapy (anastrozole 1mg (ARIMIDEX ), oral tablet once daily), followed by an additional 8 weeks of the same aromatase inhibitor th...

Embodiment 2-13

[0163] Examples 2-13 (prophetic)

[0164] The following examples demonstrate the advantages of co- or sequential administration of pharmaceutical compositions comprising androgenic agents and / or aromatase inhibitors to individuals diagnosed with breast cancer. It is to be understood that treatment of a patient with the disclosed products (in these examples as well as in the rest of the specification) can be initiated on Day 1 and continued for an appropriate period of time to effectively treat the patient without first over a period of time Apply the aromatase inhibitor itself. It is contemplated that the treatment period will last for about 3 months, about 6 months, about 1 year, about 2 years, about 4 years, or any longer or shorter period of time deemed appropriate.

Embodiment 2

[0165] Example 2 (Prophetic)

[0166] Each selected woman was given a 1 mg anastrozole tablet orally once daily (ARIMIDEX ) for 4 weeks of aromatase inhibitor therapy followed by an additional 8 weeks of the same aromatase inhibitor and at least one of the following amounts of testosterone undecanoate: 20 mg, 40 mg or 80 mg once daily. The combination of anastrozole and testosterone undecanoate is administered in a single-dose capsule containing crystalline anastrozole and encapsulated testosterone undecanoate in oil suspension. Adverse effects associated with anastrozole treatment were measured as described in Example 1. Data are expected to show improvement in at least one or more side effects. It is to be understood that the above treatments can also be started with combination products starting on day 1 and continued for a suitable period of time to effectively treat the patient. It is contemplated that treatment will last from about 6 months to about 4 years or any ti...

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PUM

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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.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of priority to 1) Australian Provisional Serial No. 2005905768 filed 19 October 2005, 2) US Provisional Serial No. 60 / 732,662 filed 3 November 2005, and 3) 2006 U.S. Provisional Serial No. 60 / 798,308, filed May 8. These applications are incorporated herein by reference in their entirety. field of invention [0003] The present invention relates to reducing side effects caused by aromatase inhibitors used to treat individuals with breast cancer. In particular, the invention provides compositions, methods and kits for reducing side effects of aromatase inhibitor-treated postmenopausal women with breast cancer comprising administering an effective amount of an androgenic agent. Furthermore, the present invention provides compositions, methods and kits for reducing side effects associated with aromatase inhibitor therapy in postmenopausal women with breast cancer comprising administering...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61P35/00A61K31/56
Inventor 斯蒂芬·奈杰尔·比勒尔
Owner HAVAH THERAPEUTICS PTY LTD