Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Phase 2
Started
2024-12-26
Last updated
2025-02-11
Condition(s) studied
Breast Adenocarcinoma
Investigational drug(s) / intervention(s)
SBRTImmuno-chemotherapy
SBRT: Target the primary tumor region with a single dose of 8Gy, or deliver a dose of 3Gy to the axillary lymph nodes, administered once a day for three consecutive days.
Immuno-chemotherapy: Standard new adjuvant treatment with toripalimab combined with chemotherapy, that is in the first phase consisting of paclitaxel and toripalimab for four cycles, followed by epirubicin, cyclophosphamide, and toripalimab for another four cycles.
Study summary
The goal of this clinical trial is to compare the efficacy and safety in patients with lymph node-positive HR+/HER2- breast cancer. The main questions it aims to answer are:
* Can the incorporation of intensified radiation to the tumor (tumor boost) enhance the pCR rate on the basis of neoadjuvant immuno-chemotherapy？
* Can it improve the level of residual cancer burden (RCB) and change the tumor immune microenvironment? and How safe will be the combined therapy?
Participants will be randomly assigned to one of three treatment regimens:
1. Preoperative toripalimab combined with SBRT targeting both the primary tumor and axillary lymph nodes, followed by chemotherapy;
2. Preoperative toripalimab combined with SBRT focused solely on the primary tumor, followed by chemotherapy;
3. Preoperative toripalimab combined with chemotherapy alone.
Following the completion of their respective treatment regimens, participants will proceed to undergo surgery. The effectiveness of the treatments will be assessed through pathological evaluations, as well as by measuring levels of residual cancer burden (RCB) and examining changes in the tumor immune microenvironment.
The study aims to evaluate the safety of these combined treatment approaches and to determine if they offer superior efficacy compared to outcomes reported in previous studies.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
pCR rate — At the end of immuno-chemotherapy up to 4-6 months Pathological Complete Response (pCR) is characterized by the absence of any invasive residual primary tumor in both the breast and lymph nodes. The primary objective of this study is to compare the pCR rates between two treatment approaches: neoadjuvant toripalimab combined with SBRT followed by immuno-chemotherapy, and neoadjuvant toripalimab combined with chemotherapy.
Trial sites (1)
Facility
City
Region
Status
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
Zhejiang
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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