| 
  
         
          | Objectives |  
               To assess the safety and response rate of trastuzumab plus docetaxel in women with HER2-overexpressing metastatic breast cancer  To evaluate the role of circulating HER2 extracellular domain (ECD) concentration as a predictor of response to trastuzumab therapy  |   
          | Eligibility |  
              Metastatic breast cancer previously treated with no more than three chemotherapy regimensHER2-overexpression assessed by IHC with the monoclonal antibody, e2-4001, or by FISH with the PathVysionTM FISH assay |   
          | Schema |           (Trastuzumab + docetaxel) q week x 3 every 4 weeks
 |  Treatment was continued until disease progression or the appearance of prohibitively toxic effects.  
        The estimated median time to progression was nine months.There was a longer time to progression in patients receiving weekly trastuzumab plus docetaxel as first-line therapy than in patients receiving it as second-line therapy. 
 Authors’ Conclusions“Weekly administration of docetaxel and trastuzumab is safe and effective for patients with metastatic breast cancer whose tumors overexpress HER-2. Further research is warranted to determine the value of serum HER-2 ECD testing in selecting and monitoring patients undergoing trastuzumab-based therapy.”
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