| Purpose:To produce a new monoclone antibody against HER-2/Neu oncoprotein (p185), and to explore the relationship between HER-2/Neu abnormal expression and prognosis of axillary lymphnode-negtive breast cancer (ANNBC).Meterials and Methods:1. The 1242-1255th amid acid of intracellular domain of p185 was synthesized and acted as the immunal antigene for raising the monoclone antibody of the pl85; 2. The specimens from 231 T1-2N0M0 breast cancer patients, operated from Jan. 1987 to Dec. 1994 in Cancer Hospital, CAMS & PUMC were researched by immunohistochemistry and analyzed retrospectively. The p185 expression of the specimens was tested with two kinds of antibodys, one made by our lab and the other Herceptest approved by FDA from DACO. The relationship between p185 expression and the prognosis were analyzed statistically.Results:1. Three strain of the monoclone antibodies were raised and identified, namely 035-E-61, 035-E-488 and 035-E-63. Compared with the polyclone antibody of DAKO, the sensitivity, specificity and accuracy of 035-E-488 were 85.3%, 79.4% and 82.7% respectively; 2. The clinical parameters including tumor size, the histologic type and the adjuvant therapy could effect the prognosis of the ANNBC. 3. The 5-year and 10-year overall survival rates(OS) and recurrent-free survival rates(RFS) of all patients... |