METHOD FOR PREDICTION OF EPIDERMAL GROWTH FACTOR RECEPTOR STATUS HER2/NEU IN PRIMARY TUMOUR IN PATIENTS WITH BREAST CANCER Russian patent published in 2022 - IPC A61B6/03 A61M36/00 A61K103/10 A61P35/00 G01N33/574 

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to oncology, and can be used to predict the status of the epidermal growth factor receptor Her2/neu in a primary tumour in patients with breast cancer. At the stage of diagnostics morphological and immunohistochemical examination with determination of histological type of breast cancer and its molecular characteristics are performed after sampling of biopsy material. Thereafter, 2 hours after administration of the preparation "^99mTc - DARPin9_29", single-photon emission computed tomography (SPECT) of the chest is performed, at which the labelled protein accumulation is assessed in the breast tumour and the symmetrical section of the opposite breast (background) and the tumour/background ratio is determined. Value of the regression equation Y is calculated by the formula: Y = -85.93 + 56.69 * X1, where -85.93 is the value of the regression coefficient of the free member; X1 is the tumour/background ratio in 2 hours after administration of the preparation "^99mTc-DARPin9_29"; X1 = 1 with tumour/background ratio less than or equal to 7.95; X1 = 2 with a tumour/background ratio of more than 7.95; 56.69 is the value of the regression coefficient of this feature. Probability P is determined by formula: P = e^Y/ (1 + e^Y), where is a mathematical constant equal to 2.72. If P is more than or equal to 50%, a high probability of the Her2-positive tissue status of the primary tumour node is predicted, while P is less than 50%.

EFFECT: method enables accurate and informative prediction of the Her2/neu epidermal growth factor receptor status in primary tumours in patients with breast cancer due to a complex of studies: morphological, immunohistochemical and radiobiological, in which accumulation of preparation "^99mTc - DARPin9_29" in breast tumour is assessed by SPECT of chest organs.

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