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【目的】比较免疫组化（IHC）与荧光原位杂交（FISH ）检测乳腺癌 HER‐2的一致性；分析 HER‐2与 ER 、PR 及淋巴结转移的相关性。【方法】采用回顾性分析，统计本院2010年至2014年 IHC 法检测的1003例乳腺癌手术标本 HER‐2蛋白及 ER 、PR 的表达情况，其中434例浸润性癌行 FISH 检测 HER‐2基因扩增状态，比较 IHC 与 FISH 方法检测 HER‐2的差异；分析 IHC 与 FISH 检测乳腺癌 HER‐2与 ER 、PR 的相关性；同时分别分析 HER‐2蛋白表达情况及 HER‐2基因扩增情况与淋巴结转移的相关性。【结果】① IHC 检测1003例乳腺癌 HER‐2蛋白表达（处）阳性率为23．93％，其中行 FISH 检测的434例浸润性癌 HER‐2基因扩增率为26．27％；IHC 检测 HER‐2蛋白（处）的病例与 FISH 检测 HER‐2基因扩增符合率为85．71％；②HER‐2蛋白表达（处）和 HER‐2基因扩增均与 ER 、PR 表达呈显著负相关；③ HER‐2蛋白表达阳性（处）病例中淋巴结转移率为45．16％；HER‐2蛋白表达阴性（0／＋）病例中淋巴结转移率为46．99％，HER‐2蛋白表达可疑（触）病理中淋巴结转移率为49．45％，组间比较差异无统计学意义（ P ＝0．1398）；HER‐2基因扩增病例中淋巴结转移率为51．58％，HER‐2基因无扩增病例中淋巴结转移率为51．99％，两者差异无统计学意义（P ＝0．346）。【结论】IHC 检测 HER‐2蛋白（－）／（＋）和（处）的病例与 FISH 检测 HER‐2基因扩增有较好的一致性；HER‐2蛋白（触）的病例需要进一步行 FISH 检测确定 HER‐2基因扩增状态，以准确指导把向药物治疗；IHC 与 FISH 检测乳腺癌 HER‐2均与 ER 、PR 呈显著负相关性，与淋巴结转移无相关性。“,”[Objective]To detect and compare the consistency of HER‐2 in breast cancer by immunohisto‐chemistry (IHC) and fluorescence in situ hybridization (FISH) ;and to analyze the correlation between HER‐2 and ER ,PR and lymph node metastasis .[Methods]The expression of HER‐2 protein ,PR and ER of 1003 cases of breast cancer surgery detected by IHC method from 2010 to 2014 was retrospectively analyzed .A‐mong them ,434 cases of invasive cancer were detected by FISH to determine HER‐2 gene amplification status to compare the differences of IHC and FISH in the detection of HER‐2 ;analysis of the correlation between IHC and FISH in the detection of HER‐2 and ER and PR of breast cancer was conducted ;at the same time , the correlation between the HER‐2 protein expression /amplification and lymph node metastasis were analyzed respectively .[Results](1) HER‐2 protein expression ( 处 ) positive rate under IHC detection was 23 .93% in 1003 cases of breast cancer .Among them ,the amplification rate of HER‐2 gene detected by FISH was 26 .27%in 434 cases of invasive cancer ;the compliance rate of HER‐2 protein ( 处 ) cases detected by IHC and HER‐2 gene amplification detected by FISH was 85 .71% .(2) HER‐2 protein expression ( 处 ) and HER‐2 gene ampli‐fication were negatively correlated with the expression of PR and ER ;(3)The lymph node metastasis rate of HER‐2 protein expression positive ( 处 ) cases was 45 .16% ;the lymph node metastasis rate of HER‐2 protein expression negative (0/+ ) cases was 46 .99% ;the rate of lymph node metastasis in HER‐2 protein suspicious ( 触 ) pathology expression was 49 .45% ,there was no significant difference between the two groups ( P =0 .1398) ;the lymph node metastasis rate was 51 .58% in the case of HER‐2 gene amplification ,the lymph node metastasis rate in HER‐2 gene non amplification case was 51 .99% ,there was no significant difference between the two ( P = 0 .346) .[Conclusion]HER‐2 protein (‐) / (+ ) and ( 处 ) cases detected by IHC have a good con‐sistency with HER‐2 gene amplification detected FISH ;HER‐2 protein ( 触 ) cases need to be further detected by FISH to determine the status of HER‐2 gene amplification so as to accurately guide targeted drug therapy ;IHC and FISH detection of HER‐2 breast cancer are all negatively correlated with PR and ER ,and has no cor‐relation with lymph node metastasis .