Preoperative Immunotherapy Combined With Stereotactic Radiation Therapy Boost in the Treatment of HER2-negative Breast Cancer
A Phase II Study of Preoperative Stereotactic Radiation Therapy Boost Combined With Short-course Immunotherapy (Pembrolizumab Versus Placebo, Randomized, Double-blind) and Standard Chemiotherapy in Patients With Newly Diagnosed HER2-negative Nonmetastatic Breast Cancer With Lack of Early Metabolic Response in 18- fluorodeoxyglucoseFDG-PET/CT After 1st Chemoterapy Cycle
Maria Sklodowska-Curie National Research Institute of Oncology
78 participants
Apr 11, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Preoperative immunotherapy (200 mg, infusion every 21 days, 4 administrations planned)
Boost of preoperative robotic stereotactic radiotherapy
0,9% NaCl in the volume 100 ml
Locations(1)
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NCT06472583