stage ?-? HER2-positive breast cancer
Conditions
Interventions
treatment group:SHR-A1811 combined with atezolizumab and pertuzumab
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Histopathologically confirmed invasive breast cancer, with no prior systemic anti-tumor treatment for breast cancer; 3. Histopathologically confirmed HER2 receptor positivity, in accordance with the criteria specified in the 2018 ASCO-CAP Guidelines for HER2 Positivity Interpretation. Confirmed by the pathology laboratory as either an immunohistochemistry (IHC) score of 3+, or an IHC score of 2+ plus positive in situ hybridization (ISH) testing (with an ISH amplification ratio >= 2.0). 4. Tumor stage conforms to stage ?-? (cT2-cT4 and any N, cM0) breast cancer per the 8th edition AJCC breast cancer staging criteria; 5. At least one measurable lesion per RECIST v1.1; 6. ECOG performance status score of 0 to 1; 7. Expected survival >= 3 months; 8. The functional levels of vital organs must meet the following requirements (no corrective treatment with any blood components or cell growth factors has been administered within 14 days prior to the first dose): a) Bone marrow function: Absolute neutrophil count (ANC) >= 1.5×10?/L, platelet count = 100×10?/L, hemoglobin >= 90 g/L; b) Hepatic and renal function: Albumin >= 3.0 g/dL, total bilirubin = 60 mL/min (calculated according to the Cockcroft-Gault formula); c) Prothrombin time (PT) and activated partial thromboplastin time (APTT) = 50%; e) Fridericia-corrected QT interval (QTcF) <= 470 msec. 9. For premenopausal women of childbearing potential: They must undergo a pregnancy test within 7 days prior to the initiation of treatment, with a negative serum pregnancy test result, and must be non-lactating; All enrolled patients should use adequate barrier contraception throughout the entire treatment period and for 6 months after the completion of treatment. 10. Voluntarily enroll in the study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up visits and all study procedures.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer; inflammatory breast cancer; 2. Previous anti-tumor treatment or radiotherapy for any malignant tumor, except for cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma; 3. Concurrent receipt of anti-tumor therapy (including endocrine therapy, bisphosphonate therapy, or immunotherapy) in other clinical trials; 4. Undergoing major non-breast cancer-related surgery within 4 weeks prior to enrollment, or failure to fully recover from such surgery; 5. History of clinically significant lung diseases (including but not limited to interstitial pneumonitis, pneumonia, pulmonary fibrosis, and radiation pneumonitis; excluding radiation changes that do not require corrective treatment), or identification of such diseases during screening. 6. Severe cardiac disease or disorder, including but not limited to the following conditions: a) Confirmed history of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmia (e.g., ventricular tachycardia), or high-grade atrioventricular block (i.e., Mobitz type II second-degree atrioventricular block or third-degree atrioventricular block) c) Angina pectoris requiring treatment with antianginal medications d) Clinically significant cardiac valvular disease e) Transmural myocardial infarction demonstrated by electrocardiogram (ECG) f) Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg); 7. Known history of allergy to any component of the study drugs; history of immunodeficiency (including positive HIV test), or other acquired/congenital immunodeficiency diseases, or organ transplant history; 8. Pregnant or lactating female patients; female patients of childbearing potential with a positive baseline pregnancy test; or patients of childbearing age who are unwilling to use effective contraception throughout the trial period and within 7 months after the last dose of the study drug. 9. Presence of severe comorbidities or other concurrent illnesses that would interfere with the planned treatment; or any other conditions deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Pathological Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-Free Survival;Breast Pathological Complete Response;Adverse Events;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactXaowei Qi
The First Affiliated Hospital of Army Medical University
Outcome results
None listed