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Clinical Trial NCT06596018 for Breast Adenocarcinoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Assessing Combined SBRT in Breast Cancer Non-Responders to Neoadjuvant Chemotherapy Phase 1, Phase 2 96 Overall Survival
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 neoadjuv...
Efficacy and Safety Evaluation of Combined Preoperative Radiotherapy in Breast Cancer Patients With No Response to Initial Neoadjuvant Chemotherapy
- Y2024-0756
Phase 2
chemo-resistance
neoadjuvant radiation
pCR rate
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorThe control group Patients in this group will continue to follow the original chemotherapy using anthracycline and/or taxane based regimens, according to their physician's preference and center policy | Chemotherapy Continue to follow the original chemotherapy regimen（anthracycline and/or taxane based regimens） |
ExperimentalThe SBRT-combined group The intervention group will receive SBRT treatment. The specific plan for SBRT is to target the primary tumor region with 24Gy/3. After the completion of SBRT, patients will continue the remaining courses of neoadjuvant chemotherapy. | SBRT Target the primary tumor region with a single dose of 8Gy using 6MV-X rays, administered once a day for three consecutive days. Chemotherapy Continue to follow the original chemotherapy regimen（anthracycline and/or taxane based regimens） |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Breast conservation rate | Breast conservation rate | Intraoperative |
pCR rate | Pathological complete response (pCR), defined by the absence of invasive residual primary tumor in the breast and lymph node.The primary objective of this study is to compare pCR rates after continuing chemotherapy plus SBRT versus continuing chemotherapy alone in patients with non-response to initial 2 cycles of neoadjuvant chemotherapy. | At the end of chemotherapy up to 21 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
3-year PFS | PFS is a measure of the time from the start of treatment until the disease progresses or a recurrence is observed, or until death occurs from any cause. | 3 years after completion of treatment |
Acute and late toxicities | Acute and late toxicities (CTCAE v 4.0) | At the end of chemotherapy and after surgery and after radiotherapy At the end of chemotherapy and after surgery and after radiotherapy: up to 30 weeks |
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.
- 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.
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityZhejiang