OncoMatch/Clinical Trials/NCT06472583
Preoperative Immunotherapy Combined With Stereotactic Radiation Therapy Boost in the Treatment of HER2-negative Breast Cancer
Is NCT06472583 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Keytruda for breast cancer.
Treatment: Keytruda — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ER expression <1% (<1%)
Cancer without estrogen receptor expression (ER<1% and PR<1%) or luminal cancer
Required: PR (PGR) expression <1% (<1%)
Cancer without estrogen receptor expression (ER<1% and PR<1%) or luminal cancer
Required: HER2 (ERBB2) negative (negative)
HER2-negative cancer
Disease stage
Required: Stage ANY T CN1-CN3, CT4 ANY N, IIA, IIB, III, IV
Excluded: Stage CT1-3 N0
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: patients may be included after 1 cycle of AC chemotherapy (1 administration) if the patient underwent a PET/CT scan using 18-FDG before starting treatment; earlier preoperative hormone therapy is allowed if, in the investigator's opinion, the patient requires the initiation of chemotherapy
No prior chemotherapy for a current diagnosis of breast cancer and no prior anthracycline chemotherapy for any reason; earlier preoperative hormone therapy is allowed if, in the investigator's opinion, the patient requires the initiation of chemotherapy; patients may be included after 1 cycle of AC chemotherapy (1 administration) if the patient underwent a PET/CT (Positron Emission Tomography and Computed Tomography) scan using 18-FDG before starting treatment
Cannot have received: anthracycline
Exception: patients may be included after 1 cycle of AC chemotherapy (1 administration) if the patient underwent a PET/CT scan using 18-FDG before starting treatment
no prior anthracycline chemotherapy for any reason; patients may be included after 1 cycle of AC chemotherapy (1 administration) if the patient underwent a PET/CT (Positron Emission Tomography and Computed Tomography) scan using 18-FDG before starting treatment
Cannot have received: anti-PD-1 therapy
Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or drugs targeting other T cell receptor inhibitors
Lab requirements
Blood counts
Hemoglobin ≥9 g/dL, neutrophil count (ANC) ≥1500/μL, platelets ≥100,000/μL
Kidney function
Creatinine concentration ≤ ULN or creatinine clearance ≥50 mL/min according to Cockcroft-Gault method in patients with creatinine concentration above ULN
Liver function
Bilirubin concentration ≤ 1.5 x ULN, except for patients with Gilbert's syndrome (then direct bilirubin ≤ ULN); AST and ALT ≤ 3 x ULN
Cardiac function
Left ventricular ejection fraction EF ≥ 50%
Bone marrow function confirmed by hemoglobin concentration ≥9 g/dL and neutrophil count (ANC) ≥1500/μL and PLT (platelets) count ≥100,000/μL; Bilirubin concentration ≤ 1.5 x ULN, except for patients with a diagnosis of Gilbert's syndrome confirmed by previous measurements or another method (then direct bilirubin ≤ ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) activity ≤ 3 x ULN; Creatinine concentration ≤ ULN or creatinine clearance ≥50 mL/min according to the Cockcroft-Gault method in patients with creatinine concentration above the upper limit of normal; Left ventricular ejection fraction EF ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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