RecruitingPhase 2NCT06472583

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


Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Enrollment

78 participants

Start Date

Apr 11, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding immunotherapy (pembrolizumab) and focused radiation therapy (SBRT) before surgery improves outcomes for people with HER2-negative breast cancer. Researchers want to find out if this combination helps shrink the tumor before surgery, increasing the chance of a complete response. **You may be eligible if...** - You are 18 or older with a diagnosis of invasive breast cancer - Your breast cancer is HER2-negative (a specific tumor type) - Your cancer has spread to lymph nodes or is at an advanced local stage - You have not received chemotherapy for your current breast cancer diagnosis - You are generally healthy enough to tolerate standard chemotherapy - Your liver, kidneys, and heart are functioning adequately **You may NOT be eligible if...** - You have inflammatory breast cancer - You are pregnant or breastfeeding - You have HIV, active Hepatitis B or C - You have an autoimmune disease requiring immunosuppressive treatment - You have received prior immunotherapy (anti-PD-1/PD-L1 drugs) - You have had a heart attack or serious heart disease in the past 6 months - You have active tuberculosis or uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKeytruda

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

RADIATIONPreoperative radiation therapy

Boost of preoperative robotic stereotactic radiotherapy

DRUGPlacebo

0,9% NaCl in the volume 100 ml


Locations(1)

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

Gliwice, Poland

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NCT06472583


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