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RECRUITING
NCT06472583
PHASE2

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

Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2024-04-11

Completion Date

2028-02-28

Last Updated

2024-06-25

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Keytruda

Preoperative immunotherapy (200 mg, infusion every 21 days, 4 administrations planned)

RADIATION

Preoperative radiation therapy

Boost of preoperative robotic stereotactic radiotherapy

DRUG

Placebo

0,9% NaCl in the volume 100 ml

Locations (1)

Maria Sklodowska-Curie National Research Institute of Oncology , Gliwice Branch

Gliwice, Poland