Breast Cancer
Conditions
Interventions
Test group :(Neoadjuvant Chemotherapy + Immunotherapy + Radiotherapy): During neoadjuvant chemotherapy, patients receive immunotherapy and radiotherapy targeting the tumor area.
**Radiotherapy Plan:
Control group :Routine neoadjuvant chemotherapy with immunotherapy, followed by standard treatment.
Sponsors
Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
15 Years to 85 Years
Inclusion criteria
Inclusion criteria: Patient Inclusion Criteria: 1. Histologically confirmed diagnosis of invasive breast adenocarcinoma, along with ER, PR, and HER2 test reports, and patients with high-risk, ER-positive, and HER2-negative breast cancer. According to ASCO CAP guidelines, ER-positive disease is defined as ER>10%, any PR, and HER2-negative. High-risk disease is defined as meeting at least two of the following three criteria: histological grade II-III, Ki-67 > 20%, ER expression =2 cm, and synchronous bilateral invasive breast cancer is permitted. 2. No evidence of distant metastasis. 3. Tumors deemed suitable for preoperative radiation therapy enhancement by a radiation oncologist. 4. ECOG performance status score of 0 or 1. 5. Screening laboratory values must meet the following criteria: i. White blood cell (WBC) count >= 2000/µL ii. Absolute neutrophil count (ANC) >= 1500/µL iii. Platelets >= 100 x 10³/µL iv. Hemoglobin >= 11.0 g/dL v. Serum creatinine = 40 ml/min) vi. AST = 2.5 x ULN viii. Total bilirubin within normal range (except for subjects with Gilbert's syndrome, whose total bilirubin must be < 3.0 mg/dL) ix. INR <= 1.5 x ULN, unless the participant is on anticoagulant therapy, as long as PT or aPTT is within the therapeutic range for the intended use of the anticoagulant x. Negative HIV screening test xi. Negative hepatitis B and hepatitis C screening tests, patients with positive results not indicating true active or chronic infection may be enrolled after discussion and consensus between the attending physician and the principal investigator. 6. Women of childbearing potential (WOCBP) must use acceptable contraceptive methods throughout the study and avoid pregnancy for at least 4 months after the last use of toripalimab to minimize the risk of pregnancy. 7. Women must not be breastfeeding. 8. Willingness to comply with the study visit schedule and the prohibitions and restrictions outlined in the protocol.
Exclusion criteria
Exclusion criteria: Patient Exclusion Criteria: 1. Inflammatory breast cancer. 2. Contraindications to radiotherapy or planned partial breast irradiation. 3. Patients who have undergone cosmetic breast augmentation at the time of diagnosis, particularly those with subglandular implants that alter breast tissue. 4. Evidence of metastatic disease. 5. Patients diagnosed with immunodeficiency or receiving chronic systemic steroid therapy (at doses exceeding 10 mg prednisone equivalent per day) or any other form of immunosuppressive treatment. 6. Other malignancies known to be progressing or requiring active treatment within the past 3 years. 7. Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered forms of systemic treatment. 8. History of (non-infectious) pneumonitis requiring steroids or current pneumonitis. 9. Active infection requiring systemic therapy. 10. Any severe or uncontrolled medical condition that, in the investigator’s opinion, may increase the risk associated with study participation or study drug administration, impair the subject’s ability to receive protocol treatment, or interfere with the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RCB postoperation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin Toxicity;Heart toxicity; | — |
Countries
China
Contacts
Public ContactYiding Chen
Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed