Status:
RECRUITING
Assessing Combined SBRT in Breast Cancer Non-Responders to Neoadjuvant Chemotherapy
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Breast Adenocarcinoma
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
Neoadjuvant chemotherapy is a crucial component in the comprehensive treatment of breast cancer patients, particularly for those with large initial tumors, axillary lymph node metastasis, HER-2 positi...
Eligibility Criteria
Inclusion
- Confirmed histologic diagnosis of invasive adenocarcinoma of the breast;
- Stage T1-4N+M0 breast cancer (i.e., stages II and III);
- Breast MRI showing no extracapsular extension of lymph node involvement;
- 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;
- ECOG performance status score of 0-2;
- Screening laboratory values must meet the following criteria:
- i. White blood cells (WBCs) ≥ 2000/μL ii. Absolute neutrophil count (ANC) ≥ 1500/μL iii. Platelets ≥ 100 x 103/μL iv. Hemoglobin ≥ 11.0 g/dL v. Serum creatinine ≤ 2 mg/dL (or glomerular filtration rate ≥ 40 ml/min) vi. AST ≤ 2.5 x upper limit of normal (ULN) vii. ALT ≤ 2.5 x ULN viii. Total bilirubin within normal limits (except subjects with Gilbert\'s syndrome, who must have total bilirubin \< 3.0 mg/dL) ix. INR ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulant(s) x. Negative HIV screening test xi. Negative screening tests for Hepatitis B and Hepatitis C. Patients with positive results that do not indicate true active or chronic infection may enroll after discussion and consensus agreement by the treating physician and principal investigator.
Exclusion
- Evidence of metastatic disease;
- Known additional malignancy that is progressing or has required active treatment within the past 3 years；
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug；
- Patients with other concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study；
- Pregnancy or breastfeeding.
Key Trial Info
Start Date :
December 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 20 2028
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06596018
Start Date
December 25 2024
End Date
September 20 2028
Last Update
December 30 2025
Active Locations (1)
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1
The Department of Radiation Oncology，the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China