HER2 low expression breast cancer
Conditions
Interventions
Trial:chemotherapy and immunotherapy
Sponsors
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-70 years old; 2. Patients with unilateral primary invasive breast cancer who meet the requirements of cT2-4NanyM0 or cT1N1-3; 3. HER-2 expression 1~2 was detected by immunohistochemistry (IHC), and patients with HER-2 expression of 2 should be confirmed by in situ hybridization test that there is no amplification of HER-2 gene, regardless of ER/PR expression; 4. At least one measurable objective lesion according to RECIST 1.1 criteria; 5. ECOG physical performance status is 0-1; 6. Expected survival time> 3 months; 7. Sufficient organ function, subjects need to meet the following laboratory indicators: a) Absolute neutrophil value (ANC) >=1.5×10?/L in the absence of granulocyte colony-stimulating factor in the last 14 days; b) Platelet >=100×10?/L without blood transfusion in the past 14 days; c) Hemoglobin > 9 g/dL in the absence of blood transfusion or erythropoietin in the last 14 days; d) Total bilirubin ULN but direct bilirubin =50 mL/min; g) good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; If the subject is on anticoagulant therapy, as long as the PT is within the intended range of the anticoagulant drug; 8. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be received within 3 days before receiving the first dose of study drug (Day 1 of Cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Females of non-childbearing potential are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy; 9. If there is a risk of conception, all subjects (regardless of male or female) are required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy drug).
Exclusion criteria
Exclusion criteria: 1. Diagnosis of other malignant diseases other than those diagnosed in this enrollment within 5 years before the first dose (excluding radically cured basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, etc.); 2. Receiving endocrine therapy within 14 days before the first use of the study drug; Received other anti-tumor drugs (including Chinese herbal medicines with anti-tumor indications) within the previous 14 days; 3. Known central nervous system metastases and/or carcinomatous meningitis; 4. Have not recovered adequately from toxicity and/or complications caused by any intervention prior to initiation of treatment (i.e., 2000 IU/mL or 104 copies/mL; Hepatitis C virus (HCV) RNA > 10³ copies/mL; Hepatitis B surface antigen (HBsAg) is concurrently positive with anti-HCV antibodies. After nucleotide antiviral therapy, those below the above criteria can be enrolled; 11. Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe liver cirrhosis; 12. Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months prior to the first dose, New York Heart Association Class III/IV congestive heart failure, and uncontrolled cardiac arrhythmia (subjects with pacemakers or atrial fibrillation and well-controlled heart rate are allowed); 13. Uncontrollable hypertension, systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy; 14. Pregnant or lactating females, or subjects who are expected to conceive or give birth during the study period from the screening visit to the completion of the safety follow-up visit (male subjects to 90 days after the last dose); 15. Received major surgical surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment or is expected to require major surgery during study treatment; 16. According to the judgment of the investigator, the patient is listed as not eligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;event -free survival; | — |
Countries
China
Contacts
Public ContactQin Tao
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Outcome results
None listed