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Core needle biopsy (CNB) has been adopted as the standard method to diagnose breast cancer and permit either optimal primary operative treatment or, increasingly, neoadjuvant cytotoxic therapy.In addition, CNB frequently is used to obtain information on tumor characteristics and marker expression for predictive and prognostic purposes, to select patients for neoadjuvant therapy and to choose postoperative adjuvant therapy.Intratumoral heterogeneity is apparent in breast cancers which appear to be composed of diverse cellular populations with distinct genetic characteristics.This may lead to inaccurate tumor characterization when biomarker determinations are made without complete evaluation of the entire tumor.Thus we undertook this study to evaluate the accuracy of CNB as a predictor of breast cancer histology and marker expression.We identified 209 Breast Cancer Registry cases, in patients undergoing primary surgical treatment, with both a preoperative CNB and a definitive surgical excision at a single institution and compared histology and marker expression from these paired samples.Statistical analysis was performed with SAS software.Kappa values were measured to assess concordance.CNB unequivocally diagnosed cancer in 93% of cases.Exact tumor histology concordance was 86%.Ductal carcinoma in situ on CNB was upgraded to invasive cancer after tumor excision in 23% of cases.Concordance between the CNB specimens and the excised tumor specimens was substantial for ER expression (88%, κ=0.71), but kappa values were <0.6 for tumor grade, mitotic rate, PR, Ki67, HER-2/neu and p53 expression, denoting only fair to moderate agreement beyond that attributable to chance.These data suggest that reliance on CNB assessments of tumor grade and marker expression for critical therapeutic decision-making may be inadvisable.Omission of tumor marker studies on excised specimens may not be a cost-saving measure.True costeffective care and best practices require that targeted therapies be utilized properly based on accurate biomarker assessment.Further study is warranted to optimize breast cancer patient care.