Patent EA-002054-B1 (EA)
Title: Method for preventing breast cancer
Inventor: COHEN FREDERIC J
IPC: A61P35/00
Filed: 1997-10-29
Abstract: 1. A method for preventing breast cancer in a human which comprises administering to said human for a sufficient term an effective dose of a compound of the formula   or a pharmaceutical ly acceptable salt or solvate thereof, said term being at least one year. 2. The method of Claim 1 wherein said effective dose is between about 30mg to about 200mg/day. 3. The method of Claim 1 wherein said effective dose is between about 50mg to about 150mg/day. 4. The method of Claim 1 wherein said effective dose is between about 60mg to about 120mg/day. 5. The method of Claim 1 wherein said effective dosage is about 60mg/day. 6. The method of Claim 1 wherein said term is at least two years. 7. The method of Claim 1 wherein said term is chronic. 8. The method of Claim 1 wherein said compound is the hydrochloride salt thereof. 9. The method of Claim 1 wherein said human is a post-menopausal female, at no particular risk of developing breast cancer. 10. The method of Claim 1 where said breast cancer is de novo. 11. The method of claim 1 wherein said human is a post-menopausal female. 12. A method for preventing breast cancer in a post-menopausal human female which comprises administering to said post-menopausal human female for a sufficient term an effective dose of a compound of the formula   or a pharmaceutically acceptable salt or solvate thereof, said term being at least one year. 13. The method of Claim 12 wherein said effective dose is between about 30mg to about 200mg/day. 14. The method of Claim 12 wherein said effective dose is between about 50mg to about 150mg/day. 15. The method of Claim 12 wherein said effective dose is between about 60mg to about 120mg/day. 16. The method of Claim 12 wherein said effective dosage is about 60mg/day. 17. The method of Claim 12 wherein said term is at least two years. 18. The method of Claim 12 wherein said term is chronic. 19. The method of Claim 12 wherein said compound is the hydrochloride salt thereof. 20. The method of Claim 12 wherein said human is a post-menopausal female, at no particular risk of developing breast cancer. 21. The method of Claim 12 where said breast cancer is de novo. 22. A method for preventing breast cancer comprising administrating to a human for a sufficient term an effective dose of a compound of formula 1   or a pharmaceutically acceptable salt or solvate thereof, said human being at no particular risk of developing breast cancer, said term being at least one year. 23. The method of Claim 22 wherein said effective dose is between about 30mg to about 200mg/day. 24. The method of Claim 22 wherein said effective dose is between about 50mg to about 150mg/day. 25. The method of Claim 22 wherein said effective dose is between about 60mg to about 120mg/day. 26. The method of Claim 22 wherein said effective dosage is about 60mg/day. 27. The method of Claim 22 wherein said term is at least two years. 28. The method of Claim 22 wherein said term is chronic. 29. The method of Claim 22 wherein said compound is the hydrochloride salt thereof. 30. The method of claim 1 or 3 wherein said human is a post-menopausal female. 31. An article of manufacture comprising packaging material and a pharmaceutical agent contained within said packaging material, wherein said packaging material comprises a label which indicates said pharmaceutical agent may be administered, for a sufficient term at an effective dose, for preventing breast cancer in a human and wherein said pharmaceutical agent is a compound of formula I   or a pharmaceutically acceptable salt or solvate thereof, said term is at least one year. 32. An article of manufacture of Claim 31 wherein said label indicates an effective dose of the compound of formula I is between about 30 mg to about 200 mg/day. 33. An article of manufacture of Claim 31 wherein said label indicates an effective dose of the compound of formula I is between about 50 mg to about 150 mg/day. 34. An article of manufacture of Claim 31 wherein said label indicates an effective dose of the compound of formula I is between about 60 mg to about 120 mg/day. 35. An article of manufacture of Claim 31 wherein said label indicates an effective dosage of the compound of formula I is about 60 mg/day. 36. An article of manufacture of Claim 31 wherein said label indicates the term of administration is at least two years. 37. An article of manufacture of Claim 31 wherein said label indicates the term of administration is chronic. 38. An article of manufacture of Claim 31 wherein said compound is the hydrochloride salt thereof. 39. An article of manufacture of Claim 31 wherein said human is a post-menopausal female, at no particular risk of developing breast cancer. 40. An article of manufacture of Claim 31 where said breast cancer is de novo. 41. An article of manufacture of Claim 31 wherein said human is a post-menopausal female. 42. An article of manufacture comprising packaging material and a pharmaceutical agent contained within said packaging material, wherein said packaging material comprises a label which indicates said pharmaceutical agent may be administered, for a sufficient term and at an effective dose, for preventing breast cancer in a post-menopausal human female wherein said pharmaceutical agent is a compound of formula I   or a pharmaceutically acceptable salt or solvate thereof, said term is at least one year. 43. An article of manufacture of Claim 42 wherein said label indicates an effective dose of the compound of formula I is between about 30 mg to about 200 mg/day. 44. An article of manufacture of Claim 42 wherein said label indicates an effective dose of the compound of formula I is between about 50 mg to about 150 mg/day. 45. An article of manufacture of Claim 42 wherein said label indicates an effective dose of the compound of formula I is between about 60 mg to about 120 mg/day. 46. An article of manufacture of Claim 42 wherein said label indicates an effective dosage of the compound of formula I is about 60 mg/day. 47. An article of manufacture of Claim 42 wherein said label indicates the term of administration is at least six months. 48. An article of manufacture of Claim 42 wherein said label indicates the term of administration is chronic. 49. An article of manufacture of Claim 42 wherein said compound is the hydrochloride salt thereof. 50. An article of manufacture of Claim 42 wherein said post-menopausal female is at no particular risk of developing breast cancer. 51. An article of manufacture of Claim 42 where, said breast cancer is de novo. 52. An article of manufacture comprising packaging material and a pharmaceutical agent contained within said packaging material, wherein said packaging material comprises a label which indicates said pharmaceutical agent may be administered, for a sufficient term at an effective dose, for preventing breast cancer in a human at no particular risk of developing breast cancer wherein said pharmaceutical agent is a compound of formula I   or a pharmaceutically acceptable salt or solvate thereof , said term is at least one year. 53. An article of manufacture of Claim 52 wherein said label indicates the effective dose of a compound of Formula I is between about 30 mg to about 200 ing/day. 54. An article of manufacture of Claim 52 wherein said label indicates the effective dose of a compound of Formula I is between about 50 mg to about 150 mg/day. 55. An article of manufacture of Claim 52 wherein said label indicates the effective dose of a compound of Formula I is between about 60 mg to about 120 mg/day. 56. An article of manufacture of Claim 52 wherein said label indicates the effective dosage of a compound of Formula I is about 60 mg/day. 57. An article of manufacture of Claim 52 wherein said label indicates the term is at least two years. 58. An article of manufacture of Claim 52 wherein said label indicates the term is chronic. 59. An article of manufacture of Claim 52 wherein said compound is the hydrochloride salt thereof. 60. An article of manufacture of Claim 52 wherein said human is a post-menopausal female. 61. The use of a compound of the formula   or a pharmaceutically acceptable salt or solvate thereof, in the preparation of a medicament for preventing breast cancer in a human, said medicament to be administered to said human for a sufficient term and at an effective dose, said term being at least one year. 62. The use of Claim 61 wherein said effective dose is between about 30 mg to about 200 mg/day. 63. The use of Claim 61 wherein said effective dose is between about 50 mg to about 150 mg/day. 64. The use of Claim 61 wherein said effective .dose is between about 60 mg to about 120 mg/day. 65. The use of Claim 61 wherein said effective dosage is about 60 mg/day. 66. The use of Claim 61 wherein said term is at least two years. 67. The use of Claim 61 wherein said term is chronic. 68. The use of Claim 61 wherein said compound is the hydrochloride salt thereof. 69. The use of Claim 61 wherein said human is a post-menopausal female, at no particular risk of developing breast cancer. 70. The use of Claim 61 where said breast cancer is de novo. 71. The use of Claim 61 wherein said human is a post-menopausal female. 72. The use of a compound of the formula   or a pharmaceutically acceptable salt or solvate thereof, in the preparation of a medicament for preventing breast cancer in a post-menopausal human female, said medicament to be administered to said post-menopausal human female for a sufficient term and at an effective dose, said term being at least one year. 73. The use of Claim 72 wherein said effective dose is between about 30 mg to about 200 mg/day. 74. The use of Claim 72 wherein said effective dose is between about 50 mg to about 150 mg/day. 75. The use of Claim 72 wherein said effective dose is between about 60 mg to about 120 mg/day. 76. The use of Claim 72 wherein said effective dosage is about 60 mg/day. 77. The use of Claim 72 wherein said term is at least two years. 78. The