Preoperative Immunotherapy Combined With Stereotactic Radiation Therapy Boost in the Treat
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
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * A woman or a man over 18 years of age. * Diagnosis of invasive breast cancer * Patient eligible for standard preoperative chemotherapy for breast cancer with anthracyclines and paclitaxel, according to the investigator's assessment * Breast cancer stage: * any T cN1-cN3 * cT4 any N (stages IIA/IIB/III/IV, excluding cT1-3 N0 patients). * Oligometastatic disease is allowed (stage IV, up to 3 foci in one organ or 2 foci in total in 2 different organs), if radical treatment using local methods is possible, both in the treatment of the primary tumor and in the treatment of the metastatic focus (radiotherapy, surgery). Patients with distant metastases who do not qualify for radical treatment cannot be included. * Cancer without estrogen receptor expression (ER\<1% and PR\<1 |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Maria Sklodowska-Curie National Research Institute of Oncology |
| Locations | Gliwice, Poland |
| Start date | 2024-04-11 |
| NCT ID | NCT06472583 |
| Official listing | https://clinicaltrials.gov/study/NCT06472583 |