Assessing Combined SBRT in Breast Cancer Non-Responders to Neoadjuvant Chemotherapy

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Sep 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at whether adding a special type of radiation therapy, called stereotactic body radiation therapy (SBRT), can help breast cancer patients who haven't responded to initial chemotherapy. The goal is to see if combining SBRT with chemotherapy can improve the number of patients who have no signs of cancer after treatment and to check if this combination is safe for patients. The trial will include female patients with early or locally advanced breast cancer who have not responded to two cycles of standard chemotherapy.

To participate, patients must have a confirmed diagnosis of breast cancer at stages II or III and must not have shown improvement after their chemotherapy. Those who join the trial will be placed into one of two groups: one group will continue with standard chemotherapy, while the other will receive SBRT along with chemotherapy. Throughout the study, researchers will track how well the treatments work and monitor for any side effects. This study is currently recruiting participants, and if you're interested, it’s a great opportunity to contribute to new treatments for breast cancer.

Gender

FEMALE

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.