NCT06596018 Assessing Combined SBRT in Breast Cancer Non-Responders to Neoadjuvant Chemotherapy
| NCT ID | NCT06596018 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Breast Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2024-12-25 |
| Primary Completion | 2027-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 96 participants in total. It began in 2024-12-25 with a primary completion date of 2027-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06596018 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06596018 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06596018 currently recruiting?
Yes, NCT06596018 is actively recruiting participants. Contact the research team at zezht@zju.edu.cn for enrollment information.
Where is the NCT06596018 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06596018 clinical trial?
NCT06596018 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 96 participants.