Non-pegylated liposomal doxorubicin triple combination therapy

Abstract

The present invention relates to a method for treating metastatic breast cancer in an individual comprising administering to an individual in need thereof a dosing regimen which comprises administering to the individual nonpegylated liposomal doxorubicin, a taxane and a HER2/neu receptor antagonist, wherein the individual previously has been administered an anthracycline.

1 .- 67 . (canceled) 
     
     
         68 . A method for treating metastatic breast cancer in an individual comprising administering to an individual in need thereof a dosing regimen which comprises administering to said individual nonpegylated liposomal doxorubicin, trastuzumab and a chemotherapeutic agent selected from the group consisting of capecitabine, vinorelbine, gemcitabine and carboplatin, wherein said individual previously has been administered an anthracycline. 
     
     
         69 . A method according to  claim 68 , wherein said previous administration of anthracycline was for the treatment of cancer. 
     
     
         70 . A method according to  claim 69 , wherein said previous administration of anthracycline was for the treatment of breast cancer. 
     
     
         71 . A method according to  claim 68 , wherein said anthracycline previously administered to said individual is selected from the group consisting of doxorubicin, idarubicin, epirubicin and daunorubicin. 
     
     
         72 . A method according to  claim 71 , wherein said anthracycline previously administered to said individual is doxorubicin. 
     
     
         73 . A method according to  claim 71 , wherein the total amount of said anthracycline previously administered to said individual is from 50 mg/m 2  to 450 mg/m 2 . 
     
     
         74 . A method according to  claim 73 , wherein the total amount of said anthracycline previously administered to said individual is from 100 mg/m 2  to 400 mg/m 2 . 
     
     
         75 . A method according to  claim 68 , wherein said dosing regimen does not substantially increase the likelihood that said individual will develop palmar-plantar erythrodysesthesia during said dosing regimen. 
     
     
         76 . A method according to  claim 68 , wherein said dosing regimen does not substantially increase the likelihood that said individual will develop congestive heart failure during said dosing regimen. 
     
     
         77 . A method according to  claim 68 , wherein said dosing regimen does not substantially increase the likelihood that said individual will suffer cardiac death during said dosing regimen. 
     
     
         78 . A method according to  claim 68 , wherein said HER2/neu receptor antagonist is trastuzumab. 
     
     
         79 . A method according to  claim 78 , wherein said nonpegylated liposomal doxorubicin and the trastuzumab are administered concomitantly. 
     
     
         80 . A method according to  claim 78 , wherein said method further comprises administering to said individual a pharmaceutically effective amount of a colony stinulating. 
     
     
         81 . A method according to  claim 80 , wherein said colony stimulating factor is filgrastim, pegilgrastim, sargramostim, lenograstim or molgramostim.