Clinical Trial

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

Study acronym: BREAST-BOOSTER
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
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.
Trial Details
NCT Number NCT06472583
Lead Sponsor Maria Sklodowska-Curie National Research Institute of Oncology
Conditions Breast Cancer
Enrollment 78 participants
Start Date 2024-04-11
Primary Completion 2028-02-28 (estimated)
Study Completion 2028-02-28 (estimated)
Updated on ClinicalTrials.gov 2024-06-25