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.

What is claimed is: 
     
         1 . A method for the treatment of a human patient susceptible to or diagnosed with a disorder characterized by overexpression of ErbB2 receptor, comprising administering an effective amount of a combination of an anti-ErbB2 antibody and a chemotherapeutic agent other than an anthracycline derivative, in the absence of an anthracycline derivative, to the human patient. 
     
     
         2 . The method of  claim 1  wherein the chemotherapeutic agent is capecitabine. 
     
     
         3 . A method for the treatment of a human patient with breast cancer characterized by overexpression of ErbB2 receptor, comprising administering a combination of an anti-ErbB2 antibody and capecitabine, in the absence of an anthracycline derivative, to the human patient in an amount effective to treat the cancer, wherein the treatment increases time to disease progression compared to therapy with capecitabine alone, and wherein said antibody binds to epitope 4D5 within the ErbB2 extracellular domain sequence. 
     
     
         4 . The method of  claim 3  wherein said breast cancer is metastatic breast carcinoma. 
     
     
         5 . The method of  claim 3  wherein said antibody is a humanized 4D5 anti-ErbB2 antibody. 
     
     
         6 . The method of  claim 3  wherein efficacy is measured by determining time to disease progression or response rate. 
     
     
         7 . The method of  claim 3  wherein the antibody is not conjugated with the capecitabine. 
     
     
         8 . A method for the treatment of a human patient with an ErbB2-expressing breast cancer, comprising administering a combination of an anti-ErbB2 antibody and capecitabine, to the human patient in an amount effective to treat the cancer, wherein the treatment increases time to disease progression compared to therapy with capecitabine alone. 
     
     
         9 . A method for the treatment of a human patient with an ErbB2-expressing breast cancer, comprising administering a combination of a humanized 4D5 anti-ErbB2 antibody and capecitabine, to the human patient in an amount effective to treat the cancer, wherein the treatment increases time to disease progression compared to therapy with capecitabine alone.