Neoadjuvant Toripalimab and Radiotherapy Treatment in N+ HR+ Breast Cancer

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Nov 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for women with a specific type of breast cancer called lymph node-positive HR+/HER2-negative breast cancer. The goal is to see if combining a medication called toripalimab with targeted radiation therapy can improve treatment outcomes compared to standard chemotherapy alone. Researchers want to find out if this combined therapy can help shrink tumors better before surgery and if it is safe for patients. Participants will be randomly assigned to one of three treatment groups, which vary in the use of radiation and chemotherapy.

To be eligible for the trial, women must have a high-risk form of breast cancer that meets certain criteria, such as having specific hormone receptor levels and a tumor size of at least 1 cm. Participants should not have had previous treatments for breast cancer, and they need to be in good overall health. Throughout the trial, patients will receive the assigned treatments and then undergo surgery, with their health closely monitored to assess how well the treatments work and their safety. This trial is currently recruiting participants, so if you meet the criteria, this could be an opportunity to help advance breast cancer treatment.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • High-risk HR+/HER2-negative breast cancer is defined as ER≥1%, HER2-negative (\<2+ Her2 IHC or \<2.2 HER2/CEP17 ratio by FISH) and either histologic grade II-III or a high-risk genomic assay score (Oncotype RS\>25, high risk Mammaprint, PAM-50, EndoPredict or ProSigna score). primary tumor size ≥1.0 cm in maximum diameter and axillary node-positive breast cancer;
• • Stage T1-4N+M0 (i.e., Stage II, III), with confirmed N+ by biopsy, and no signs of distant metastasis;
• • The initial PD-L1 expression level conducted on the tumor tissue sample with Combined Positive Score (CPS) or Tumor Proportion Score (TPS)\< 10%;
• • ECOG score of 0-1;
• • 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:
• • Inflammatory breast cancer
• • Life-threatening organ dysfunction or complications, active infectious diseases, active hepatitis B, hepatitis C virus infection, autoimmune diseases within two years, undergoing immunosuppressive drug treatment or chronic systemic corticosteroid therapy (dose exceeding 10mg per day of prednisone or equivalent);
• • Clinically symptomatic heart disease;
• • Previous systemic treatment or radiotherapy for breast cancer;
• • Patients with cosmetic breast implants, i.e., having implants under the skin at the time of diagnosis;
• • Radiotherapy contraindications: history of radiotherapy;
• • Women shall not be breastfeeding.