Use of 4-hydroxy tamoxifen in treatment and prevention of benign breast disease

A technology for hydroxy tamoxifen and breast diseases, which can be applied in the direction of diseases, drug combinations, drug delivery, etc., and can solve problems such as increased risk of breast cancer

Active Publication Date: 2011-08-31
BESINS HEALTHCARE LUXEMBOURG (LU)
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The risk of developing breast cancer is further increased when the presence of benign breast disease is combined with a family history of breast cancer

Method used

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  • Use of 4-hydroxy tamoxifen in treatment and prevention of benign breast disease
  • Use of 4-hydroxy tamoxifen in treatment and prevention of benign breast disease
  • Use of 4-hydroxy tamoxifen in treatment and prevention of benign breast disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Example 1: Verification of transdermal release of 4-hydroxy tamoxifen

[0059] [ 3 An alcohol solution of H]-4-hydroxy tamoxifen was applied directly to the breasts of four breast cancer patients. After surgery, both the resected tissue and the breast tissue surrounding the tumor are radiosuppressed (Kuttenn et al., 1985).

[0060] In a follow-up study, 9 of 12 patients scheduled for surgical resection of hormone-dependent breast cancer received Z-[ 3 H]-4-hydroxy tamoxifen (80μCi) treatment, 3 received Z-[ 3 Treatment with H]-tamoxifen (80 μCi) was used for comparison. [ 3 H]-labeled drug is applied directly to the patient's diseased breast. Three areas of breast tissue—the tumor, the tissue immediately surrounding the tumor, and normal tissue—were excised and immediately frozen in liquid nitrogen. In addition, plasma and urine samples were obtained at predetermined intervals and frozen for analysis.

[0061] Table 2 shows the analysis results. 4-Hydroxy tamoxi...

Embodiment 2

[0070] Example 2: Pharmacokinetic and pharmacodynamic verification of transdermally administered 4-hydroxy tamoxifen compared to oral administration of 20 mg tamoxifen

[0071] This study compared tissue and plasma concentrations of 4-hydroxy tamoxifen after transdermal administration of a hydroalcoholic gel to those after oral tamoxifen (Pujol, 1995).

[0072] Thirty-one patients scheduled for breast cancer surgery were randomly assigned to 1 of 5 groups. As listed in Table 3, they were treated with either oral tamoxifen or transdermal 4-hydroxy tamoxifen. Treatment was performed daily for 3-4 weeks before surgery. The study evaluated three different doses of 4-hydroxy tamoxifen (0.5, 1, or 2 mg / day) and two-area application (applied to both breasts or to a large skin surface including arms, forearms, and shoulders). ). A group of patients received oral tamoxifen ( ) 20mg / day (10mg each time, twice a day) treatment.

[0073] Table 3: Treatment Groups

[0074]

[007...

Embodiment 3

[0092] Example 3: Tolerance and pharmacokinetic verification of transdermal administration of 4-hydroxy tamoxifen to healthy women

[0093] This study demonstrates the tolerability and pharmacokinetics of topically applied 4-hydroxytamoxifen gel in healthy premenopausal women aged 18-45 years. Each participant applied the gel on each day of two menstrual cycles.

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PUM

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Abstract

The present invention provides methods for treating and preventing benign breast disease by administering 4-hydroxy tamoxifen to a patient. When percutaneously administered to a patient's breasts, 4-hydroxy tamoxifen concentrates locally, and exerts an anti-estrogenic effect. In patients with benign breast disease, this effect induces disease regression. In patients at risk for developing breast cancer, the anti-estrogenic effect prevents formation of benign breast conditions that can lead to cancer.

Description

technical field [0001] The present invention relates to the treatment and prevention of benign breast disease with 4-hydroxy tamoxifen (4-OHT). Background technique [0002] Benign breast disease refers to common, nonmalignant abnormalities in breast tissue. These aberrations consist of numerous lesions with well-defined histologic features and can be classified as proliferative or nonproliferative. Notable examples include adenosis, cyst, ductal dilatation, fibroadenoma, fibrocystic disease, fibrosis, hyperplasia, and metaplasia. Benign breast disease is estrogen-related and thus primarily affects adult premenopausal women. In these populations, benign breast disease can interfere with childbirth and contraception, and current treatment options negatively impact patients' quality of life. [0003] Although benign breast disease rarely poses a direct threat to the patient's health, it often causes persistent emotional anxiety and physical pain. In particular, benign lesi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/138A61K47/14A61K47/38A61P5/32A61P15/00A61K47/02A61K47/10
CPCA61K47/14A61K47/38A61K47/02A61K47/10A61K31/138A61K9/0014A61P15/00A61P35/00A61P5/32
Inventor 伊丽莎白·莱内斯图尔
Owner BESINS HEALTHCARE LUXEMBOURG (LU)
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