Breast cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Understand the content of the clinical trial and agree with the participants; 2. Subjects aged 18-65 years old; 3. The subjects diagnosed as TNBC by pathology; 4. Patients with newly diagnosed and untreated non metastatic breast cancer confirmed by imaging evaluation; 5. Patients who have not received any treatment before; 6. Subjects with T >= 3cm or ln (+); 7. Subjects with ECoG score of 0-1; 8. Subjects with good organ function (blood cells, heart, liver, kidney, coagulation); 9. Informed consent of patients and written consent; 10. The patients had good compliance and voluntarily accepted follow-up, treatment, laboratory examination and other research steps according to the plan.
Exclusion criteria
Exclusion criteria: 1. Has the second primary malignant tumor within the last 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix; 2. Received chemotherapy, targeted therapy and radiation therapy in the past 12 months; 3. Has received anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs; 4. Has an active autoimmune disease requiring systemic treatment in the past 2 years; 5. Diagnosed with immunodeficiency or received immunosuppressive therapy within 1 week; 6. History of human immunodeficiency virus infection; 7. History of non-infectious pneumonia with glucocorticoid treatment; 8. Current pneumonia, active tuberculosis, active hepatitis B virus or hepatitis C virus infection; 9. Active infections undergoing systemic treatment; 10. Currently participating in other clinical trials; 11. Pregnant or lactating women or fertile women who do not use contraception; 12. Having other severe acute or chronic physical or mental problems, or abnormal laboratory tests, which may increase the risk associated with study participation or drug use, or interfere with the judgment of study results, and are deemed unfit for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Countries
China
Contacts
Liaoning Province Cancer Hospital