Non-specific invasive ductal carcinoma of breast, Grade 3, ER>= 1%,HER2 negative,Ki-67>20%
Conditions
Interventions
Experimental group:Radiotherapy followed by chemotherapy combined with toripalimab immunotherapy
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 75 years, with no gender restrictions. 2.Histologically or pathologically confirmed non-special invasive ductal carcinoma, grade 3, with estrogen receptor (ER) expression >= 1%, HER2-negative, and Ki-67>20%. 3.Clinical stage T1c-T2 ( >= 2 cm) N1-2 M0 or T3-4c N0-2 M0; 4.No prior treatment for the current malignancy; 5.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1. 6.The participant or legal representative has been informed of the nature of the study, understands the provisions of the protocol, is able to ensure compliance, and has signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to recombinant humanized anti-PD-1 monoclonal antibody drugs or their components. 2.Currently participating in and receiving other investigational treatments. 3.Previous systemic treatment for breast cancer, including systemic chemotherapy, targeted therapy, immunotherapy, etc. 4.Distant metastatic lesions of breast cancer confirmed by imaging or pathology. 5.Patients with active pulmonary tuberculosis (TB), currently undergoing anti-TB treatment, or who have received anti-TB treatment within the last year before screening. 6.Uncontrollable or symptomatic hypercalcemia. 7.Clinically uncontrolled active infections, including but not limited to acute pneumonia. 8.Uncontrollable major epileptic seizures or superior vena cava syndrome. 9.History or concurrent presence of other malignant tumors (except for non-melanoma skin basal cell carcinoma or squamous cell carcinoma that has been treated curatively and has no evidence of disease recurrence, breast/cervical carcinoma in situ, superficial bladder carcinoma, and other in situ carcinomas). 10.Known history of interstitial pneumonia, idiopathic pulmonary fibrosis, organizing pneumonia (such as cryptogenic organizing pneumonia), drug-induced pneumonia, idiopathic pneumonia, evidence of active pneumonia found on chest CT scan at screening, or other moderate to severe pulmonary diseases that significantly affect lung function. 11.Known human immunodeficiency virus (HIV) infection (known positive HIV antibody). 12.Severe cardiovascular disease, such as New York Heart Association (NYHA) Class 2 or higher heart failure, unstable angina, unstable arrhythmia, myocardial infarction, or cerebrovascular accident within the last 6 months before enrollment. 13.Received systemic immunosuppressive drugs (e.g., corticosteroids or immunosuppressive drugs) for any active autoimmune disease within 2 years before the start of the study. 14.Received live virus vaccines within 4 weeks before the start of the study. 15.Patients who have previously undergone allogeneic stem cell or solid organ transplantation. 16.Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test before the first dose of medication, or patients with fertility who are unwilling to accept contraceptive measures or whose sexual partners are unwilling to accept contraceptive measures. 17.The investigator deems that the patient may affect protocol compliance (such as a history of psychiatric disorders or drug abuse), cannot benefit from this clinical study, or affects the patient's ability to sign the informed consent form (such as drug abuse and substance abuse), or has any other clinically significant disease or condition that is not suitable for participation in this clinical study (including but not limited to: laboratory abnormalities, clinically active diverticulitis, intra-abdominal abscess, intestinal obstruction, peritoneal metastatic carcinoma).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;event free survival;safety; | — |
Countries
China
Contacts
Public ContactPeifen Fu
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed