Breast cancer
Conditions
Interventions
Experimental Group:AC sequential TP combined with toripalimab
Sponsors
Thyroid and Breast Surgery Department of North Sichuan Medical College Affiliated Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Be at least 18 years old; 2. All lesions were diagnosed as triple-negative breast cancer by the center (as defined by ASA-CAP); 3. Determined by the researcher through imaging assessment, clinical assessment, or a combination of both as a new diagnosis, no previous treatment received, and no metastatic disease (according to the AJCC 7th Edition Primary Tumor - Regional lymph node staging criteria, regardless of the lymph node status, the minimum tumor size is =2.0 cm; 4. Lymph nodes are positive regardless of the size of the tumor; 5. The ECOG performance status score is either 0 or 1 point (on a 5-point scale, with a higher score indicating a more severe degree of disability). 6. Good organ function. Patients with bilateral or multifocal primary tumors and inflammatory breast cancer are also eligible for enrollment.
Exclusion criteria
Exclusion criteria: 1.Active autoimmune diseases that have received systemic treatment in the past two years; 2. Have been diagnosed with immune deficiency or have used immunosuppressive therapy within the past week; 3. Have a history of human immunodeficiency virus infection; 4. Has received glucocorticoid treatment for non-infectious pneumonia; 5. Currently suffering from pneumonia; 6. Active tuberculosis; 7. Active hepatitis B virus or hepatitis C virus infection; 8. Currently undergoing systemic treatment to control any active infections; 9. And suffering from cardiovascular diseases of clinical significance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Residual cancer burden (RCB);Safety;Complete remission rate of breast pathology (bpCR);Complete alleviation of axillary lymph node pathology (apCR); | — |
Countries
China
Contacts
Public ContactXiaobo Zhao
North Sichuan Medical College Affiliated Hospital
Outcome results
None listed