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 (Jun 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
Treatments studied
Immunotherapy
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.
Frequently asked questions
Is NCT06472583 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ER?
Yes, ER expression <1% is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression <1% is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage ANY T CN1-CN3 or CT4 ANY N or IIA or IIB or III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages