Abstract
529 Background: sHER2 is a circulating oncoprotein cleaved from full-length, membrane-bound HER2. Previous data support that increased sHER concentration is an indicator of poor prognosis and predictor of poor response to chemotherapeutic and hormone treatment in metastatic breast cancer. The role of sHER2 level on the outcome of patients in the adjuvant setting has not been defined, which we evaluated in the context of N9831. Methods: The objectives were to analyze the association between baseline sHER2 and disease-free survival (DFS) in patients (pts) randomized to Arms A (standard chemotherapy) and C (standard chemotherapy with concurrent trastuzumab) of N9831. Baseline serum samples of 1,423 pts from both arms were analyzed for sHER2 using the ADVIA Centaur HER2 assay (Siemens Diagnostics; Tarrytown, NY). Cut off value of 15 ng/mL was used as recommended by the manufacturer/FDA. Patients who cancelled prior to receiving therapy, ineligible pts, and pts whose HER2 status was not corroborated by central...
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