OncoMatch/Clinical Trials/NCT06596018
Assessing Combined SBRT in Breast Cancer Non-Responders to Neoadjuvant Chemotherapy
Is NCT06596018 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Chemotherapy for breast adenocarcinoma.
Treatment: Chemotherapy — The goal of this clinical trial is to assess whether the addition of preoperative stereotactic body radiation therapy (SBRT) can improve pathological complete response (pCR) rates and safety in breast cancer patients who do not respond to initial neoadjuvant chemotherapy. The main questions it aims to answer are: * Can the combination of SBRT with chemotherapy increase pCR rates in non-responders to initial neoadjuvant chemotherapy? * Does the addition of SBRT to chemotherapy have acceptable safety and tolerability profiles? Participants in this trial will be early or locally advanced breast cancer patients who have shown no response to two cycles of standard neoadjuvant chemotherapy. They will be randomly assigned to either continue with the standard chemotherapy (control group) or receive SBRT in addition to continuing the standard chemotherapy (intervention group). The primary outcome measures will be pCR rate and breast conservation rate. Secondary outcomes will include 3-year local progression-free survival, overall survival, surgical complications, and treatment toxicities.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Disease stage
Required: Stage T1-4N+M0, II, III
Excluded: Stage METASTATIC DISEASE
Stage T1-4N+M0 breast cancer (i.e., stages II and III); Evidence of metastatic disease [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: neoadjuvant chemotherapy — neoadjuvant
The standard neoadjuvant chemotherapy regimen has been deemed ineffective after two cycles, with disease assessed as stable (SD) or progressive (PD) according to RECIST 1.1 criteria
Lab requirements
Blood counts
WBCs ≥ 2000/μL; ANC ≥ 1500/μL; Platelets ≥ 100 x 10^3/μL; Hemoglobin ≥ 11.0 g/dL
Kidney function
Serum creatinine ≤ 2 mg/dL (or glomerular filtration rate ≥ 40 ml/min)
Liver function
AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN; Total bilirubin within normal limits (except subjects with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL)
Screening laboratory values must meet the following criteria: ... (see above for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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