Breast cancer
Conditions
Interventions
Control group:Albumin paclitaxel + toripalimab
Experimental Group:Radiotherapy + albumin paclitaxel + toripalimab
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The patient voluntarily participated in this study and signed the informed consent form. 2. Female, aged = 18 years old and = 75 years old; 3.ECOG score: 0 to 1; 4. Histological examination confirmed that TNBC, that is, HER2, ER and PR were all negative. The specific criteria are as follows: •HER2 negative must meet one of the following conditions: IHC 0; IHC 1+; IHC 2+ should further apply in situ hybridization (ISH) methods to determine HER2 negativity. To be ER negative, the following conditions must be met: less than 1% of the tumor nuclei in the entire section express ER; PR negative requires that less than 1% of the tumor cell nuclei in the entire section express PR. For patients with ER/PR expression =1% to =1 7. At least two measurable lesions, and the radiotherapy professional physician determines that they are available for SBRT and LDRT. 8. The functional levels of major organs must meet the following requirements: 1) Blood routine: Neutrophils (ANC) >=1.5×10^9/L; Platelet count (PLT) >=90×10^9/L; Hemoglobin (Hb) >=90 g/L; 2) Liver function: Total bilirubin (TBIL) 3 months; 11. Voluntarily join this study, sign the informed consent form, have good compliance and be willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1.At the same time, receive anti-tumor therapies in other clinical trials, including chemotherapy or immunotherapy 2. Brain metastases that are active and require brain radiotherapy as determined by magnetic resonance imaging (MRI) assessment and previous imaging evaluations during the screening period. (Note: Patients with newly diagnosed brain metastases that do not require brain radiotherapy; those who have previously received local treatment for brain metastases and whose imaging examination results have confirmed stability for >=1 month can participate in the study.) 3. Meningeal metastasis; 4. Those who have a history of allergy to the drug components of this plan; There is a history of immune deficiency, including a positive HIV test, or suffering from other acquired or congenital immune deficiency diseases, or a history of organ transplantation; 5. Patients with severe cardiovascular diseases, such as those who have experienced New York Heart Association (NYHA) grade 3 or above heart failure, myocardial infarction, unstable arrhythmia, or LVEF < 50% within 3 months prior to randomization; 6. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial period; 7. Suffering from serious concomitant diseases or other comorbidities that may interfere with the planned treatment, or any other circumstances where the researcher deems the patient unsuitable to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressives Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Duration of response;Disease control rate;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactXiaohua Zeng;Mei Liu
Chongqing University Cancer Hospital
Outcome results
None listed