HER2-positive early breast cancer FUSCCHER2-CLA.
Conditions
Interventions
HER2-positive early breast cancer FUSCCHER2-CLA:Phesgo
Sponsors
The affiliated hospital of southwest medical university
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Signed informed consent, aged 18-70 years; 2.Patient has the ability to follow the study protocol at the discretion of the investigator; 3.Confirmed HER2-positive Breast Cancer, FUSCC HER2-CLA; 4.At least one measurable lesion (RECIST 1.1); 5.Primary breast cancer > 1.5 cm in size or positive lymph nodes without distant metastasis; neoadjuvant therapy planned; 6.ECOG 0 or 1; 7.LVEF>= 55%; 8.Neutrophil count (ANC) >= 1.5 x 10^9/L; 9.Hemoglobin (Hb) >= 90 g/L; 10.Platelet count (PLT) >= 90 × 10^9/L; 11.Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) = 30 mL/min (calculated using the Cockcroft-Gault formula);
Exclusion criteria
Exclusion criteria: 1.History of invasive breast cancer; 2.Stage IV (Metastatic) Breast Cancer; 3.Patients with concurrent 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 pectoris requiring anti-anginal medication, serious cardiac arrhythmias not adequately controlled with medication, severe conduction abnormalities or clinically significant valvular heart disease; 8.High risk uncontrolled arrhythmias; 9.Significant symptoms ( >= Grade 2) related to left ventricular dysfunction, arrhythmia, or myocardial ischemia; 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.Evidence of transmural myocardial infarction on electrocardiogram; 13.History of autoimmune disease or immunodeficiency; 14.Serious or uncontrolled infections that may affect the assessment of study treatment or study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, pulmonary infection, etc. 15.Known hypersensitivity to any component of the trial medication; 16.Treatment with an investigational drug within 28 days prior to start of study treatment; 17.Pregnant or lactating female patients; 18.Any other condition that, in the opinion of the investigator, would make participation in this study inappropriate;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tpCR in the MRI-responsive group; | — |
Secondary
| Measure | Time frame |
|---|---|
| bpCR in the MRI-responsive group;apCR in the MRI-responsive group; | — |
Countries
China
Contacts
Public ContactPan Guangrui
The affiliated hospital of southwest medical university
Outcome results
None listed