The goal of the study is to assess the safety and effectiveness of the combination of anti-PD1 immunotherapy (pembrolizumab) and radiotherapy in the preoperative treatment of HER2-negative breast cancer resistant to classical chemotherapy.
The subject of the intervention will be:
1. Randomly assigned in a 2:1 ratio and double-blinded addition of pre-operative immunotherapy with pembrolizumab or placebo to standard chemotherapy 2. Addition of preoperative radiotherapy boost delivered with a CyberKnife radiosurgery system concomitantly with the use of paclitaxel (+/- carboplatin) and pembrolizumab / placebo.
A woman or a man over 18 years of age.
Diagnosis of invasive breast cancer
Patient eligible for standard preoperative chemotherapy for breast cancer with anthracyclines and paclitaxel, according to the investigator's assessment
any T cN1-cN3
Inflammatory breast cancer (cT4d)
Hypersensitivity to drugs or excipients used in the study, which, in the opinion of the researcher, does not allow therapy to be initiated
Major surgical or medical procedure within 14 days prior to study entry; does not apply to ovariectomy performed laparoscopically, including as a risk-reducing surgical procedure and ovarian biopsy as a fertility preservation procedure and diagnostic procedures
Parallel coexisting invasive cancer
Single group
Keytruda
DrugPreoperative immunotherapy (200 mg, infusion every 21 days, 4 administrations planned)
Preoperative radiation therapy
RadiationBoost of preoperative robotic stereotactic radiotherapy
Placebo
Drug0,9% NaCl in the volume 100 ml
The histopathological confirmation of complete tumor regression in postoperative material performed in a population of 52 patients receiving immunotherapy in combination with radiotherapy
The statistical analysis will be performed by comparison to the initial assumptions, according to Simon's scheme. The finding of complete tumor regression (confirmed histopathologically) in more than 11 patients out of the group of 52 enrolled will be treated as fulfillment of the primary endpoint.
Assessment of complete regression in postoperative histopathological examination in the population of all 78 patients receiving preoperative chemotherapy and radiotherapy
The finding of of complete tumor regression in more than 13 patients out of the group of 78 included and receiving both chemotherapy and radiotherapy will be treated as fulfillment of the secondary endpoint criterion.
The assessment of the response to preoperative treatment by assessing postoperative material in histopathological examination
Assessment of regression under the influence of pembrolizumab in postoperative histopathological examination using the quantitative method, taking into account the degree of partial regression
The comparison of the Invasive Disease Free Survival time the group treated with pembrolizumab with radiotherapy to the group treated with placebo with radiotherapy
Invasive Disease Free Survival time will be evaluated according to Proposal for Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials
Quality of life evaluated by QLQ-C30 questionnaire (Quality of Live questionnaire) comparision beteewen groups
General health condition based on the QLQ-C30 scale
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