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

NCT06472583 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-06-25

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Maria Sklodowska-Curie National Research Institute of Oncology

    lead OTHER

Principal Investigators

  • Michal Jarzab · Maria Sklodowska-Curie National Research Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-11
Primary Completion
2028-02-28
Completion
2028-02-28

Countries

  • Poland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06472583 on ClinicalTrials.gov