Breast cancer
Conditions
Interventions
Group 1:(Docetaxel + carboplatin + trastuzumab) * 6 cycles
Group 2:Docetaxel + trastuzumab - epirubicin + cyclophosphamide + trastuzumab
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Signing informed consent 2. aged 18-65 years old, female; 3. Breast cancer meets the following criteria: - histologically confirmed invasive breast cancer, primary tumor diameter determined by local standard assessment method >2 cm tumor stage: early (T2-3, N0-1, M0) or locally advanced (T2-4, N2 or N3, M0); - Pathologically confirmed HER2 positive breast cancer, defined as >10% immunoreactive cells with immunohistochemistry (IHC) score of 3+ or in situ hybridization (ISH) results for HER2 gene amplification (HER2 gene signaling and centromere The ratio of the granule 17 signal is Ratio = 2.0 or the ratio of the HER2 gene is = 6); - known hormone receptor status (ER and PgR); The Eastern Tumor Collaborative Group (ECOG) has a physical status score of =1; Complete all necessary baseline laboratory measurements and imaging studies prior to randomization, meeting the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocytes, platelet-up drugs): 1) blood routine test: Neutrophils (ANC) = 1.5 × 10^9/L; platelet count (PLT) = 90 × 10^9/L; hemoglobin (Hb) = 90g/L; 2) Blood biochemistry: Total bilirubin (TBIL) = 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 1.5 × ULN; alkaline phosphatase = 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) = 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) = 55%; 4) The QT interval (QTcF) corrected by the 12-lead electrocardiogram Fridericia method is <470 msec; For patients who are not menopausal (menopause = 12 months) or who have not undergone surgical sterilization (no ovaries and/or uterus): consent to abstinence or use of a type during treatment and at least 7 months after the last dose in the study treatment Highly effective non-hormonal contraceptive methods or two effective non-hormonal contraceptive methods; women of childbearing age, tested negative for serum pregnancy test 14 days before randomization; The investigator judged that he or she could abide by the research protocol.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer; 2. inflammatory inflammatory breast cancer; 3. Patients during pregnancy and lactation; 4. Have received previous anti-tumor treatment or radiation therapy for any malignant tumor; 5. Have a history of other malignant tumors within 5 years prior to screening, with appropriate treatment for cervical carcinoma in situ, except for non-melanoma skin cancer or stage I uterine cancer; 6. Also receive anti-tumor therapies in another research-type trial, including endocrine therapy, bisphosphonate therapy, or immunotherapy; 7. He has undergone major surgery that was not associated with breast cancer within 4 weeks prior to randomization, or the patient has not fully recovered from such surgery; 8. severe heart disease or discomfort, including but not limited to the following: - a history of diagnosis of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmia (such as ventricular tachycardia) or higher-grade atrioventricular conduction (AV) block (ie Mobitz II second degree atrioventricular block or third degree atrioventricular block); - need angina pectoris for anti-angina medication; - clinically significant valvular heart disease; - ECG shows transmural myocardial infarction; - poor control of hypertension (systolic blood pressure > 180 mmHg and / or diastolic blood pressure > 100 mmHg); known to have a history of allergies to the drug components of this regimen; history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; Have a severe concomitant disease or other concomitant disease that interferes with planned treatment, or any other condition that the investigator believes is not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Countries
China
Contacts
Public ContactZhenzhen Liu
He'nan Cancer Hospital
Outcome results
None listed