Preoperative Immunotherapy Combined With Stereotactic Radiation Therapy Boost in the Treatment of HER2-negative Breast Cancer

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 pembroliz

Trial Details

NCT ID
NCT06472583
Phase
PHASE2
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Keytruda
  • Preoperative radiation therapy
  • Placebo
Locations (sample)
  • Gliwice, Poland|50.29761,18.67658

Key Eligibility Criteria

  • 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 asses…
  • Breast cancer stage:

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Breast Cancer Trials on Trialify →