TREATMENT WITH ANTI ErbB2 ANTIBODIES

Abstract

The present invention concerns the treatment of disorders characterized by the overexpression of ErbB2. More specifically, the invention concerns the treatment of human patients susceptible to or diagnosed with cancer overexpressing ErbB2 with a combination of an anti-ErbB2 antibody and a chemotherapeutic agent other than an anthracycline, e.g. doxorubicin or epirubicin. The invention further provides a method of treating cancer in a human patient comprising administering effective amounts of an anti-ErbB2 antibody and a cardioprotectant to the patient.

1 - 15 . (canceled) 
     
     
         16 . A method for the treatment of breast cancer, comprising administering to a human patient with breast cancer characterized by overexpression of ErbB2 receptor, an effective amount of a combination of a humanized anti-ErbB2 antibody that binds to epitope 4D5 within the ErbB2 extracellular domain sequence, as determined by a cross-blocking assay using said antibody and antibody 4D5 obtainable from deposit ATCC CRL 10463, and a taxoid, in the absence of an anthracycline derivative, under warning instructions providing that the combination is not to be used with an anthracycline-type chemotherapeutic agent. 
     
     
         17 . The method of  claim 16 , wherein said breast cancer is metastatic breast cancer. 
     
     
         18 . The method of  claim 17 , wherein said breast cancer is metastatic breast carcinoma. 
     
     
         19 . The method of  claim 17 , wherein the metastatic breast cancer is characterized by 2+ to 3+ overexpression of the ErbB2 receptor, as determined by immunohistochemistry or fluorescence in situ hybridization (FISH). 
     
     
         20 . The method of  claim 17 , wherein the metastatic site is characterized by 2+ to 3+ overexpression of the ErbB2 receptor. 
     
     
         21 . The method of any one of  claims 16  to  20 , wherein the humanized anti-ErbB2 antibody is rhuMAb HER2. 
     
     
         22 . The method of any one of  claims 16  to  20 , wherein the taxoid is paclitaxel. 
     
     
         23 . The method of  claim 21 , wherein the taxoid is paclitaxel. 
     
     
         24 . The method of  claim 17 , wherein said human patient did not receive prior cytotoxic chemotherapy for treatment of metastatic breast cancer. 
     
     
         25 . The method of  claim 24 , wherein said human patient received prior cytotoxic chemotherapy in the adjuvant setting. 
     
     
         26 . The method of  claim 25 , wherein said human patient received prior hormonal therapy for treatment of metastatic breast cancer. 
     
     
         27 . The method of  claim 26 , wherein said hormonal therapy comprises administration of tamoxifen. 
     
     
         28 . The method of  claim 16 , wherein the combined administration comprises coadministration using separate formulations or a single formulation or the anti-ErbB2 antibody and the taxoid. 
     
     
         29 . The method of  claim 16 , wherein the combined administration comprises consecutive administration or the anti-ErbB2 antibody and the taxoid, in either order. 
     
     
         30 . The method of  claim 16 , wherein the combined administration comprises simultaneous administration of the anti-ErbB2 antibody and the taxoid.