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US4666885A Expired / Lapsed US ⏱️ 0.0 years remaining

Combination therapy for treatment of female breast cancer

Assignee: Individual
•
Filing: 1985-02-08
•
Granted: 1987-05-19
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Expires: 2005-02-08
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Abstract

Abstract A method of treatment of breast cancer in susceptible animals whose ovarian hormonal secretions are blocked by surgical or chemical means, e.g., by use of an LH-RH agonist, e.g., [D-Trp 6 , des-Gly-NH 2 10 ]LH-RH ethylamide with a therapy comprising administering an antiandrogen, e.g., flutamide and an optionally, an inhibitor of adrenal sex steroid biosynthesis e.g., aminoglutethimide, pharmaceutical compositions useful for such treatment and two, four and five component pharmaceutical kits containing such compositions are disclosed.

Inventors

  • 👤 Fernand Labrie

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-26 12:28
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/33; A61K31/395; A61K31/435; A61K31/44; A61K31/445; A61K31/495; A61K38/00; A61K38/04; Y; Y10; Y10S; Y10S930/00; Y10S930/01; Y10S930/13

Claims Analysis

Total Claims: 38
Claim 1
Independent Claim 50 words
A method of treating breast cancer in a warm-blooded female animal in need of such treatment which comprises blocking the ovarian hormonal secretions of said animal by surgical or chemical means and in association therewith administering to said animal a therapeutically effective amount of an antiandrogen or pharmaceutical compositions thereof.
Claim 2
Independent Claim 50 words
A method of treating breast cancer in a warm-blooded female animal in need of such treatment which comprises blocking the ovarian hormonal secretions of said animal by surgical or chemical means and in association therewith administering to said animal a therapeutically effective amount of an antiandrogen or pharmaceutical compositions thereof.
Claim 3
Dependent Claim 11 words
The method of claim 1 wherein the ovaries are surgically removed.
Claim 4
Dependent Claim 35 words
The method of claim 1 wherein the ovarian hormonal secretions are blocked by administering an amount of a LH--RH agonist or a LH--RH antagonist or a pharmaceutical composition thereof effective to block said hormonal secretions.
Claim 5
Dependent Claim 20 words
The method according to claim 1 wherein the LH--RH agonist is administered parenterally together with a pharmaceutically acceptable parenteral carrier.
Claim 6
Dependent Claim 18 words
The method of claim 1 wherein the antiandrogen is administered orally, together with a pharmaceutically acceptable oral carrier.
Claim 7
Dependent Claim 64 words
The method of claim 1 wherein the LH--RH agonist is a nonapeptide or a decapeptide represented by the formula: L-pyroglutamyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-X-Y-L-arginyl-L-prolyl-Z, wherein X is D-tryptophyl, D-leucyl, D-alanyl, iminobenzyl-D-histyl, 3-(2-naphthyl)-D-alanyl, O-tert-butyl-D-seryl, D-tyrosyl, D-lysyl, D-phenylalanyl or N-methyl-D-alanyl and wherein Y is L-leucyl, D-leucyl, N.sup.α -methyl-D-leucyl, N.sup.α -methyl-L-leucyl or D-alanyl and wherein Z is glycyl-NHR 1 or NHR 1 wherein R 1 is H, lower alkyl or haloloweralkyl.
Claim 8
Dependent Claim 19 words
The method of claim 1 wherein the LH--RH agonist or LH--RH antagonist is administered as a subcutaneous depot injection.
Claim 9
Dependent Claim 10 words
The method of claim 1 wherein the antiandrogen is 1-(3'-trifluoromethyl-4'-nitrophenyl)-4,4-dimethylimidazoline-2,5-dione.
Claim 10
Dependent Claim 10 words
The method of claim 1 wherein the antiandrogen is 4'-nitro-3'-trifluoromethylisobutyranilide.
Claim 11
Independent Claim 44 words
A method of treating breast cancer in a castrated warm-blooded female animal having breast cancer which comprises administering to said animal a therapeutically effective amount of an association of an antiandrogen and at least one inhibitor of sex steroid biosynthesis or pharmaceutical compositions thereof.
Claim 12
Independent Claim 44 words
A method of treating breast cancer in a castrated warm-blooded female animal having breast cancer which comprises administering to said animal a therapeutically effective amount of an association of an antiandrogen and at least one inhibitor of sex steroid biosynthesis or pharmaceutical compositions thereof.
Claim 13
Dependent Claim 12 words
The method of claim 10 wherein the ovaries have been surgically removed.
Claim 14
Dependent Claim 35 words
The method of claim 10 wherein the ovarian hormonal secretions are blocked by administering an amount of a LH--RH agonist or a LH--RH antagonist or a pharmaceutical composition thereof effective to block said hormonal secretions.
Claim 15
Dependent Claim 14 words
The method of claim 10 which further comprises administering hydrocortisone or pharmaceutical compositions thereof.
Claim 16
Dependent Claim 28 words
The method of claim 10 wherein the antiandrogen and at least one inhibitor of sex steroid biosynthesis are each administered orally, together with a pharmaceutically acceptable oral carrier.
Claim 17
Dependent Claim 19 words
The method of claim 10 wherein the inhibitor of sex steroid biosynthesis is aminoglutethimide or a pharmaceutical composition thereof.
Claim 18
Dependent Claim 19 words
The method of claim 10 wherein the inhibitor of sex steroid biosynthesis is ketoconazole or a pharmaceutical composition thereof.
Claim 19
Dependent Claim 10 words
The method of claim 10 wherein the antiandrogen is 1-(3'-trifluoromethyl-4'-nitrophenyl)-4,4-dimethylimidazoline-2,5-dione.
Claim 20
Dependent Claim 10 words
The method of claim 10 wherein the antiandrogen is 4'-nitro-3'-trifluoromethylisobutyranilide.
Claim 21
Independent Claim 50 words
A method of treating breast cancer in a warm-blooded female animal having breast cancer which comprises administering to said animal a therapeutically effective amount of an association of a LH--RH agonist or a LH--RH antagonist, an antiandrogen and at least one inhibitor of sex steroid biosynthesis or pharmaceutical compositions thereof.
Claim 22
Independent Claim 50 words
A method of treating breast cancer in a warm-blooded female animal having breast cancer which comprises administering to said animal a therapeutically effective amount of an association of a LH--RH agonist or a LH--RH antagonist, an antiandrogen and at least one inhibitor of sex steroid biosynthesis or pharmaceutical compositions thereof.
Claim 23
Dependent Claim 19 words
The method of claim 19 wherein the LH--RH agonist is administered parenterally together with a pharmaceutically acceptable parenteral carrier.
Claim 24
Dependent Claim 25 words
The method of claim 19 wherein the inhibitor(s) of sex steroid biosynthesis and the antiandrogen are each administered orally, together with pharmaceutically acceptable oral carrier.
Claim 25
Dependent Claim 23 words
The method of claim 19 wherein the LH--RH agonist is administered at a daily parenteral dose of between about 250 and 500 μg.
Claim 26
Dependent Claim 42 words
The method of claim 19 wherein the antiandrogen is administered at a daily oral dose of between about 0.20 and 40 mg/kg and the inhibitor of steroid formation is administered at a daily oral dose of between about 0.20 and 40 mg/kg.
Claim 27
Dependent Claim 19 words
The method of claim 19 wherein one inhibitor of sex steroid biosynthesis or a pharmaceutical composition thereof is administered.
Claim 28
Dependent Claim 19 words
The method of claim 24 wherein the inhibitor of sex steroid biosynthesis is ketoconazole or a pharmaceutical composition thereof.
Claim 29
Dependent Claim 19 words
The method of claim 24 wherein the inhibitor of sex steroid biosynthesis is aminoglutethimide or a pharmaceutical composition thereof.
Claim 30
Dependent Claim 18 words
The method of claim 19 wherein two inhibitors of sex steroid biosynthesis or pharmaceutical composition thereof are administered.
Claim 31
Dependent Claim 20 words
The method of claim 27 wherein the two inhibitors of steorid biosynthesis are aminoglutethimide and ketoconazole or pharmaceutical compositions thereof.
Claim 32
Independent Claim 61 words
The method of inhibiting the growth of breast tumors in a warm blood female animal whose ovarian hormonal secretions have been previously blocked by surgical or chemical means which comprises administering to the warm-blooded animal having such tumors a therapeutically effective amount of an association of an antiandrogen, hydrocortisone and an inhibitor of adrenal sex steroid biosynthesis, or pharmaceutical compositions thereof.
Claim 33
Independent Claim 61 words
The method of inhibiting the growth of breast tumors in a warm blood female animal whose ovarian hormonal secretions have been previously blocked by surgical or chemical means which comprises administering to the warm-blooded animal having such tumors a therapeutically effective amount of an association of an antiandrogen, hydrocortisone and an inhibitor of adrenal sex steroid biosynthesis, or pharmaceutical compositions thereof.
Claim 34
Dependent Claim 12 words
The method of claim 29 wherein the ovaries have been surgically removed.
Claim 35
Dependent Claim 36 words
The method of claim 29 wherein the ovarian hormonal secretions are blocked by administering an amount of a LH--RH agonist or a LH--RH antagonist or a pharmaceutical composition there of effective to block said hormonal secretions.
Claim 36
Dependent Claim 27 words
The method of claim 31 wherein the antiandrogen and an inhibitor of adrenal sex steroid biosynthesis are each administered orally together with a pharmaceutically acceptable oral carrier.
Claim 37
Dependent Claim 10 words
The method of claim 29 wherein the antiandrogen is 1-(3'-trifluoromethyl-4'-nitrophenyl)-4,4-dimethylimidazoline-2,5-dione.
Claim 38
Dependent Claim 10 words
The method of claim 29 wherein the antiandrogen is 4'-nitro-3'-trifluoromethylisobutyranilide.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1990-05-18 1990-11-17 1991-05-19 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1994-05-18 1994-11-17 1995-05-19 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1998-05-18 1998-11-17 1999-05-19 $7700.00 Window Closed / Lapsed

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