Breast Cancer
Conditions
Interventions
experimental group 1:Radiotherapy
experimental group 2:Immunotherapy
Sponsors
Affiliated Cancer Hospital of Shandong First Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old, female; 2. MRI and ultrasonography were performed before surgery, and the imaging stage was (cT1-2 N0-1M0). 3. Pathology and immunohistochemistry of the primary breast were confirmed as triple-negative breast cancer; the axillary lymph nodes of patients diagnosed with N1 by imaging should be confirmed as triple-negative breast cancer by pathology and immunohistochemistry; 4. There is at least one measurable lesion (according to RECIST version 1.1, the long diameter of the measurable breast lesions on spiral CT scan is >=10 mm, or the short diameter of CT scan of lymph node lesions is >=10 mm, and the scan slice thickness is not greater than 5 mm; local treatment), and the measurable lesions are suitable for surgery; 5. Expected survival period >= 6 months; 6. ECOG score 0-1; 7. The main organ function is good, that is, the relevant inspection indicators meet the following requirements within 1 week before enrollment: blood routine examination: hemoglobin content (HB) >= 90g/L (no blood transfusion within 28 days); absolute neutrophil count (ANC) >=1.5x10^9/L; Platelet count (PLT) >=100x10^9/L; Biochemical tests: Serum total bilirubin (TBIL) = 50%; 9. Women of childbearing age must have a negative pregnancy test (blood/urine) result within 1 week before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug; for men, they should For surgical sterilization or agree to use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug; 10. No previous anti-tumor treatment, including surgery, chemotherapy, radiotherapy and targeted therapy; subjects voluntarily joined the study, signed the informed consent, good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Suffering from other active malignant tumors within 3 years before entering the study. Except for locally treatable and cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma in situ of the breast, and papillary thyroid carcinoma; 2. There is any active autoimmune disease or a history of autoimmune disease with expected recurrence (including but not limited to: the subject has skin diseases that do not require systemic treatment such as vitiligo, psoriasis, alopecia, type I diabetes or Children with complete remission of asthma without any intervention in adulthood can be included; asthma patients who require medical intervention with bronchodilators cannot be included); 3. Lactating women; 4. Systemic use of antibiotics for >= 7 days within 4 weeks before the first dose, or unexplained fever > 38.5°C during the screening period/before the first dose (according to the investigator's judgment, fever caused by tumor can be included in the group) ; 5. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 6. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis or co-infection with hepatitis B and C; 7. Participated in any other drug clinical research within 4 weeks before the first administration; 8. Have a clear history of neurological or psychiatric disorders, including epilepsy and dementia; known history of psychotropic substance abuse, alcohol or drug abuse; 9. Known to be allergic to the study drug or any of its excipients; or to have had a severe allergic reaction to other monoclonal antibodies; 10. Patients deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Countries
China
Contacts
Public ContactHuang Wei
the Affiliated Cancer Hospital of Shandong First Medical University
Outcome results
None listed