Methods And Compositions For Diagnosing Breast Cancer

Abstract

Mammastatin has an approximate molecular weight of 44 kDa in its inactive, non-phosphorylated form. Normal mammary cells express functional phosphorylated forms having approximate molecular weights of 53 kDa and 49 kDa. Metastatic mammary cells either do not express Mammastatin at all, or do not express the 53 kDa or 49 kDa, phosphorylated forms. Mammary cancer cells are inhibited in their growth by the administration of phosphorylated Mammastatin.

1 - 16 . (canceled) 
     
     
         17 . A method comprising the steps of:
 a) determining an amount of mammastatin in a patient's sample by contacting said mammastatin with an antibody that binds specifically to mammastatin encoded by SEQ ID NO: 1;   b) comparing the amount of determined mammastatin to a control, said control comprising an amount of mammastatin from a normal, non-breast cancer female; and   c) correlating an amount of mammastatin less than the control as a characteristic of breast cancer.   
     
     
         18 . The method of  claim 17 , wherein said antibody is a monoclonal antibody. 
     
     
         19 . The method of  claim 17 , wherein said antibody is selected from the group consisting of monoclonal antibody 3C6 and monoclonal antibody 6B8. 
     
     
         20 . The method of  claim 17 , wherein said sample comprises mammary tissue, mammary cells, or fluids from said patient. 
     
     
         21 . The method of  claim 17 , wherein said patient's sample comprises blood or blood serum from said patient. 
     
     
         22 . The method of  claim 17 , where said step of determining an amount of mammastatin comprises use of an immunoassay. 
     
     
         23 . The method of  claim 22 , wherein the immunoassay is selected from the group consisting of a Western blot, a dot blot, and an enzyme-linked immunoabsorbent assay. 
     
     
         24 . The method of  claim 17 , wherein said control comprises an amount of mammastatin of at least 10 ng/ml. 
     
     
         25 . The method of  claim 17 , wherein said control comprises mammary cells, or mammary tissue, or fluid obtained from a normal, non-breast cancer female. 
     
     
         26 . A mammastatin protein comprising at least one amino acid sequence selected from the group consisting of SEQ ID NO: 2 and SEQ ID NO: 3. 
     
     
         27 . A monoclonal antibody specific for the mammastatin protein of  claim 26 . 
     
     
         28 . A method comprising the steps of:
 a) determining an amount of mammastatin in a patient's sample by contacting said mammastatin with an antibody that binds specifically to a mammastatin protein comprising at least one amino acid sequence selected from the group consisting of SEQ ID NO: 2 and SEQ ID NO: 3;   b) comparing the amount of determined mammastatin to a control, said control comprising an amount of mammastatin from a normal, non-breast cancer female; and   c) correlating an amount of mammastatin less than the control as a characteristic of breast cancer.   
     
     
         29 . The method of  claim 28 , wherein said antibody is a monoclonal antibody. 
     
     
         30 . The method of  claim 28 , wherein said antibody is selected from the group consisting of monoclonal antibody 7G6, monoclonal antibody 3C6, and monoclonal antibody 6B8. 
     
     
         31 . The method of  claim 28 , wherein said sample comprises mammary tissue, mammary cells, or fluids from said patient. 
     
     
         32 . The method of  claim 28 , wherein said patient's sample comprises blood or blood serum from said patient. 
     
     
         33 . The method of  claim 28 , where said step of determining an amount of mammastatin comprises use of an immunoassay. 
     
     
         34 . The method of  claim 33 , wherein the immunoassay is selected from the group consisting of a Western blot, a dot blot, and an enzyme-linked immunoabsorbent assay. 
     
     
         35 . The method of  claim 28 , wherein said control comprises an amount of mammastatin of at least 10 ng/ml. 
     
     
         36 . The method of  claim 28 , wherein said control comprises mammary cells, or mammary tissue, or fluid obtained from a normal, non-breast cancer female.