HER2-positive, stage II to III breast cancer
Conditions
Interventions
Experimental group:toripalimab , Pertuzumab and Trastuzumab Injection (Subcutaneous Injection), nab-paclitaxel
T-DM1
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Optional topics (self-funded 1. Signed informed consent, age 18-75; 2. The patient has the ability to follow the study protocol according to the investigator's judgment; 3. Confirmed HER2-positive breast cancer; 4. Have at least one measurable lesion (RECIST 1.1); 5. The size of the main breast cancer is > 2 cm or lymph nodes are positive by imaging methods, and there is no distant metastasis; 6. ECOG is 0 or 1; 7.LVEF=55%; 8. Neutrophil count (ANC) >= 1.5 × 10^9/L; 9. Platelet count (PLT) >=90×10^9/L; 10. Hemoglobin (Hb)>=90g/L; 11. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) = 30 mL/min (calculated using the Cockcroft-Gault formula); 14. No serious autoimmune disease; )
Exclusion criteria
Exclusion criteria: 1.History of invasive breast cancer; 2.Stage IV (metastatic) breast cancer; 3.Patients with synchronous bilateral invasive breast cancer; 4.Prior systemic therapy for breast cancer; 5.Ulcerative or inflammatory breast cancer; 6.History of congestive heart failure of any grade; 7.Angina requiring anti-anginal medication, poorly controlled severe arrhythmias, severe conduction abnormalities, or clinically significant valvular heart disease; 8.High-risk uncontrolled arrhythmias; 9.Significant symptoms related to left ventricular dysfunction, arrhythmias, or myocardial ischemia (grade =2); 10.Myocardial infarction within 12 months prior to enrollment; 11.Uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg); 12.Electrocardiographic evidence of transmural myocardial infarction; 13.History of autoimmune disease or immunodeficiency; 14.Severe or uncontrolled infections that may interfere with study treatment or assessments, including but not limited to active hepatitis virus infections, HIV antibody positivity, or pulmonary infections; 15.Known hypersensitivity or allergic reaction to any component of the investigational drugs; 16.Any other disease, metabolic abnormality, physical examination finding, or clinical laboratory finding that would preclude the use of study drugs; 17.Receipt of any investigational drug within 28 days prior to study treatment initiation; 18.Pregnant or breastfeeding women; 19.Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pathological complete response(tpCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event;Event Free Survival(EFS);Breast pathological complete response(bpCR);ORR;Overall survival (OS); | — |
Countries
China
Contacts
Public ContactXaowei Qi
The First Affiliated Hospital of Army Medical University
Outcome results
None listed