Composition for and method of preventing or treating breast cancer

Abstract

The present invention is a composition for preventing, minimizing, or reversing the development or growth of breast cancer. The composition contains a combination of a selective estrogen receptor modulator selected from at least one of raloxifene, droloxifene, toremifene, 4′-iodotamoxifen, and idoxifene and at least one isoflavone selected from genistein, daidzein, biochanin A, formononetin, and their respective naturally occurring glucosides and glucoside conjugates. The present invention also provides a method of preventing, minimizing, or reversing the development or growth of breast cancer in which a selective estrogen receptor modulator selected from at least one of raloxifene, droloxifene, toremifene, 4′-iodotamoxifen, and idoxifene is co-administered with at least one isoflavone selected from genistein, daidzein, biochanin A, formononetin, and their naturally occuring glucosides and glucoside conjugates to a woman having or predisposed to having breast cancer.

What is claimed is:  
     
         1 . A method for preventing, minimizing, or reversing the development or growth of breast cancer in a woman comprising co-administering to said woman droloxifene and genistein, said droloxifene being administered to said woman in an amount effective to prevent, minimize, or reverse the development or growth of breast cancer, and said genistein being administered for the purpose of preventing or minimizing uterine hypertrophy induced by administration of said droloxifene wherein said genistein is administered in an amount effective to prevent or minimize uterine hypertrophy induced by administration of droloxifene.  
     
     
         2 . The method of    claim 1    wherein co-administration of said droloxifene and said genistein is concurrent.  
     
     
         3 . The method of    claim 1    wherein co-administration of said droloxifene and said genistein is sequential.  
     
     
         4 . The method of    claim 1    wherein from about 0.5 mg to about 500 mg of said droloxifene is administered to said woman per day.  
     
     
         5 . The method of    claim 4    wherein from about 5 mg to about 100 mg of said droloxifene is administered to said woman per day.  
     
     
         6 . The method of    claim 1    wherein from about 1 mg to about 1000 mg of said genistein is administered to said woman per day.  
     
     
         7 . The method of    claim 6    wherein from about 10 mg to about 200 mg of said genistein is administered to said woman per day.  
     
     
         8 . The method of    claim 1    wherein said genistein is administered to said woman in an amount sufficient to augment prevention, minimization, or reversal of the development or growth of breast cancer provided by said droloxifene.  
     
     
         9 . The method of    claim 1    wherein said genistein is administered to said woman to prevent or minimize the development of endometrial cancer.  
     
     
         10 . The method of    claim 1    wherein said droloxifene and said genistein are administered in a pharmaceutical preparation.  
     
     
         11 . The method of    claim 10    wherein said pharmaceutical preparation is a tablet, capsule, powder, suspension, or solution.