A phase II study of preoperative stereotactic radiation therapy boost combined with short-course immunotherapy (pembrolizumab versus placebo, randomized, double-blind) and standard chemotherapy in patients with newly diagnosed HER2-negative non-metastatic breast cancer with lack of early metabolic response in 18-fluorodeoxyglucoseFDG-PET/CT after 1st chemoterapy cycle

HER2 negative breast cancer

Histopathological confirmation in the postoperative material of complete tumor regression after preoperative systemic treatment (pCR), defined as the absence of invasive tumor tissue in the breast and regional lymph nodes (AJCC/UICC definition, allows residual DCIS tissue as pCR ypT0/is N0)

Assessment of complete regression in the postoperative histopathological examination in the population of all 78 patients receiving preoperative chemotherapy and radiotherapy. The presence of pCR in more than 13 patients out of a group of 78 enrolled and receiving chemotherapy and radiotherapy will be treated as fulfillment of the secondary endpoint criterion, Evaluation of response to preoperative treatment by evaluating postoperative material in histopathological examination according to the RCB (Residual Cancer Burden) protocol, comparing the group treated with pembrolizumab with radiotherapy to the group treated with placebo and radiotherapy, by comparing the numerical RCB ratio between both groups, Assessment of time to recurrence of invasive cancer - (Invasive Disease Free Survival, IDFS), comparison of the group treated with pembrolizumab with radiotherapy to the group treated with placebo + radiotherapy (according to Proposal for Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials: The STEEP System, Hudis et al. Journal of Clinical Oncology 2007), Comparison of quality of life - general health status based on the QL2 scale of the EORTC QLQ-C30 questionnaire of the group treated with pembrolizumab with radiotherapy to the group treated with placebo and radiotherapy

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