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Abstract Breast cancer is the most common neoplasm among women in the majority of the developed countries, accounting for one-third of newly diagnosed malignancies. Breast cancer is a complex disease encompassing multiple tumor entities, each characterized by distinct morphology, behavior and clinical implications. Besides estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2, novel biomarkers have shown their prognostic and predictive values. MicroRNAs are short 18-22 nucleotide non-coding RNAs that may alter gene expression by binding messenger RNAs (mRNAs), and may affect cell proliferation, differentiation, and cell death. Cancer associated microRNAs may be oncogenic, or tumor suppressive, with oncogenic microRNAs promoting tumor growth, and tumor suppressive microRNAs being suppressed in cancer. They may be a potential biomarker, as they are released by all cell types via exosomes and may be detected at any tumor stage. MicroRNA21 is an onco-microRNA. There is a large amount of evidence indicating that microRNA21 is associated with regulation of cellular proliferation and differentiation during development. Also, it is possible to develop treatment strategies by targeting microRNA 21. The present study was designed to identify serum microRNA21 expression in breast cancer Egyptian females. To achieve this goal this study was conducted on 52 BC female patients and 28 controls. All patients had: 1- Clinical and physical evaluation to exclude any other diseases. 2- Full pathological identification of hormonal receptors (ER,PR HER2) ,tumor stage , grade and lymph node metastasis. 3- CA15.3serum level. 4- Total RNA was extracted from serum samples followed by reverse transcription real time PCR. Serum microRNA21 was measured using qPCR. Expression of serum microRNA21was calculated using the comparative cycle threshold (CT) method (2–ΔΔCT). Statistical analysis of the studied parameters showed the following results: Micro RNA21 serum expression level was significantly higher in BC patients than in control group although 94.2% of the patients group were in early stage I and II. This may emphasize its value as biomarker for breast cancer in its early stages. Accuracy has been determined by plotting a receiver-operating characteristic (ROC) curve. AUC was 0.94 At the cut-off value of 0.82, the sensitivity and specificity of serum microRNA 21 expression levels was 100%, 35.7% respectively. Positive predictive value was 74.2% and negative predictive value was 100%. Micro RNA21 serum expression level showed significant correlation with serum CA15.3. Our study had some limitations, including small sample size and a limited ability to generalize our results since all our patients were Egyptian females |