Methods for predicting the efficacy of treatment

Abstract

Clinical tests for testing therapeutic sensitivity of cancerous breast tissue and methods and kits for performing the same are described herein. Embodiments of the present invention are directed to methods for predicting the efficacy of treatment of breast cancer. In addition, certain embodiments are directed to a kit for testing therapeutic sensitivity of breast cancer tissue.

1 - 16 . (canceled) 
     
     
         17 . A method for predicting the efficacy of treatment of breast cancer comprising: analyzing an expression profile of marker genes from a cancerous breast tissue; and predicting the efficacy of treatment if the expression profile from the cancerous breast tissue matches a predetermined expression profile that indicates a patient will respond to the treatment wherein the marker gene is selected from a group consisting of ASPM, NCAPG, CDKN3, AURKA, FOXM1, CEP55, TNFRSF6B, FGFBP1, CAPRIN2, TUBG1, ZWILCH, RRM2, ACTB, ACTN1, EPHA2, TRIP13, CKS2, VRK1, DUSP4, EIF4A1, SERPINE2, ODC1 and combinations thereof. 
     
     
         18 . The method of  claim 17  further comprising developing an expression profile from said marker genes. 
     
     
         19 . The method of  claim 17 , wherein the treatment is selected from a chemotherapeutic agent, radiation and a combination thereof. 
     
     
         20 . The method of  claim 19 , wherein the chemotherapeutic agent comprises alkylating agents, antimetabolites, anthracyclines, anti-tumor inhibitors, anti-mitotic agents, topoisomerase I inhibitors, topoisomerase II inhibitors, corticosteroids and combinations thereof. 
     
     
         21 . The method of  claim 17  further comprising providing chemotherapy to said patients. 
     
     
         22 . The method of  claim 17 , further comprising generating a report indicating the likelihood of long-term survival without breast cancer recurrence in a patient. 
     
     
         23 . A kit for testing therapeutic sensitivity of breast cancer tissue comprising: a means for identifying the expression profile of a tissue sample having probes to a specific set of genes or proteins associated with the disease; and labels, reagents, and other materials or instructions for labeling and preparing reagents and other materials necessary to develop an expression profile of one or more marker genes. 
     
     
         24 . The kit of  claim 23 , wherein the marker gene is selected from a group consisting of ASPM, NCAPG, CDKN3, AURKA, FOXM1, CEP55, TNFRSF6B, FGFBP1, CAPRIN2, TUBG1, ZWILCH, RRM2, ACTB, ACTN1, EPHA2, TRIP13, CKS2, VRK1, DUSP4, EIF4A1, SERPINE2, ODC1 and combinations thereof. 
     
     
         25 . A method of identifying a breast cancer patient who is likely to respond to a treatment for breast cancer comprising: developing a genetic profile from marker genes from a breast tissue sample; and identifying a breast cancer patient as likely to respond to a treatment for breast cancer if the expression profile matches a predetermined expression profile that indicates that a patient will respond to the treatment wherein the marker gene is selected from the group consisting of ASPM, NCAPG, CDKN3, AURKA, FOXM1, CEP55, TNFRSF6B, FGFBP1, CAPRIN2, TUBG1, ZWILCH, RRM2, ACTB, ACTN1, EPHA2, TRIP13, CKS2, VRK1, DUSP4, EIF4A1, SERPINE2, ODC1 and combinations thereof. 
     
     
         26 . The method of  claim 25 , wherein the treatment is selected from a chemotherapeutic agent, radiation and a combination thereof. 
     
     
         27 . The method of  claim 26 , wherein the chemotherapeutic agent comprises alkylating agents, antimetabolites, anthracyclines, anti-tumor inhibitors, anti-mitotic agents, topoisomerase I inhibitors, topoisomerase II inhibitors, corticosteroids and combinations thereof. 
     
     
         28 . The method of  claim 25  further comprising providing chemotherapy to said patients. 
     
     
         29 . The method of  claim 27  wherein the anti-mitotic agent is a taxane. 
     
     
         30 . The method of  claim 20  wherein the anti-mitotic agent is a taxane.