Novel Method of Diagnosing, Monitoring, Staging, Imaging and Treating Breast Cancer

Abstract

The present invention provides new markers and methods for detecting, diagnosing, monitoring, staging, prognosticating, imaging and treating breast cancer.

1 . A BCSG comprising:
 (a) a polynucleotide of SEQ ID NO:1, 2, 3, 4, 5, 18 or 20 or a variant thereof;   (b) a protein expressed by a polynucleotide of SEQ ID NO:1, 2, 3, 4, 5, 18 or 20 or a variant thereof; or   (c) a polynucleotide which is capable of hybridizing under stringent conditions to the antisense sequence of SEQ ID NO: 1, 2, 3, 4, 5, 18 or 20.   
     
     
         2 . The BCSG of  claim 1  comprising a protein of SEQ ID NO:19 or 21. 
     
     
         3 . A method for diagnosing the presence of breast cancer in a patient comprising:
 (a) determining levels of a BCSG of  claim 1  in cells, tissues or bodily fluids in a patient; and   (b) comparing the determined BCSG levels with levels of BCSG in cells, tissues or bodily fluids from a normal human control, wherein a change in determined levels of BCSG in said patient versus normal human control is associated with the presence of breast cancer.   
     
     
         4 . A method of diagnosing metastases of breast cancer in a patient comprising:
 (a) identifying a patient having breast cancer that is not known to have metastasized;   (b) determining levels of a BCSG of  claim 1  in cells, tissues, or bodily fluid from said patient; and   (c) comparing the determined BCSG levels with levels of BCSG in cells, tissue, or bodily fluid of a normal human control, wherein an increase in determined BCSG levels in the patient versus the normal human control is associated with breast cancer which has metastasized.   
     
     
         5 . A method of staging breast cancer in a patient having breast cancer comprising:
 (a) identifying a patient having breast cancer;   (b) determining levels of a BCSG of  claim 1  in a sample of cells, tissue, or bodily fluid from said patient; and   (c) comparing determined BCSG levels with levels of BCSG in cells, tissues, or bodily fluid of a normal human control, wherein an increase in determined BCSG levels in said patient versus the normal human control is associated with breast cancer which is progressing and a decrease in the determined BCSG levels is associated with breast cancer which is regressing or in remission.   
     
     
         6 . A method of monitoring breast cancer in a patient for the onset of metastasis comprising:
 (a) identifying a patient having breast cancer that is not known to have metastasized;   (b) periodically determining levels of a BCSG of  claim 1  in samples of cells, tissues, or bodily fluid from said patient; and   (c) comparing the periodically determined BCSG levels with levels of BCSG in cells, tissues, or bodily fluid of a normal human control, wherein an increase in any one of the periodically determined BCSG levels in the patient versus the normal human control is associated with breast cancer which has metastasized.   
     
     
         7 . A method of monitoring a change in stage of breast cancer in a patient comprising:
 (a) identifying a patient having breast cancer;   (b) periodically determining levels of a BCSG of  claim 1  in cells, tissues, or bodily fluid from said patient; and   (c) comparing the periodically determined BCSG levels with levels of BCSG in cells, tissues, or bodily fluid of a normal human control, wherein an increase in any one of the periodically determined BCSG levels in the patient versus the normal human control is associated with breast cancer which is progressing in stage and a decrease is associated with breast cancer which is regressing in stage or in remission.   
     
     
         8 . A method of identifying potential therapeutic agents for use in imaging and treating breast cancer comprising screening molecules for an ability to bind to a BCSG of  claim 1  wherein the ability of a molecule to bind to BCSG is indicative of the molecule being useful in imaging and treating breast cancer. 
     
     
         9 . An antibody which specifically binds a BCSG of  claim 1 . 
     
     
         10 . A method of imaging breast cancer in a patient comprising administering to the patient the antibody of  claim 9 . 
     
     
         11 . The method of  claim 10  wherein said antibody is labeled with paramagnetic ions or a radioisotope. 
     
     
         12 . A method of treating breast cancer in a patient comprising administering to the patient the antibody of  claim 9 . 
     
     
         13 . The method of  claim 12  wherein the antibody is conjugated to a cytotoxic agent. 
     
     
         14 . A method of treating breast cancer in a patient comprising administering to the patient a molecule which downregulates expression or activity of a BCSG of  claim 1 . 
     
     
         15 . A method of inducing an immune response against a target cell expressing a BCSG of  claim 1  comprising delivering to a human patient an immunogenically stimulatory amount of a BCSG protein of  claim 1  so that an immune response is mounted against the target cell. 
     
     
         16 . A vaccine for treating breast cancer comprising a BCSG of  claim 1 .