Breast cancer
Conditions
Interventions
Experimental group:Doxorubicin hydrochioride liposome injection plus cyclophosphamide followed by docetaxel plus trastuzumab and pertuzumab
Control group :Docetaxel plus carboplatin combined with trastuzumab and pertuzumab
Sponsors
Liaoning Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Female patients aged from 18 to 65 years old. Pregnancy test is required for premenopausal and perimenopausal patients (-), and reliable contraceptive methods are promised during treatment; 2.Patients with histopathologically confirmed HER-2 Positive (defined by IHC 3+ or ISH positive) breast cancer; 3.Clinical stage II-IIIC; 4.After diagnosis, the patients have not received any anti-tumor treatment, and are eligible for surgical treatment after neoadjuvant treatment; 5.Before enrollment, abdominal ultrasound, head and chest CT, and systemic bone scan did not reveal distant metastasis; 6.Participants must have at least one measurable disease according to RECIST 1.1. 7.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 8.New York Heart Association (NYHA) cardiac function class was I; 9.No myocardial ischemia manifestations in ECG. Echocardiographic LVEF > 55%. Cardiac markers: cardiac troponin (cTnI) and brain natriuretic peptide (BNP) test values were within normal values. 10.The main organs function normally, that is, they meet the following criteria:White blood cell counts>= 3.5x10^9/L, absolute neutrophil counts (ANC) >= 1.5x10^9/L; Platelets >= 100x10^9/L;Hemoglobin >= 10g/dL; Serum creatinine <= 1.5xUpper limit of normal (ULN);Aspartate aminotransferase (AST) <=2.5xULN;Alanine aminotransferase (ALT) <=2.5xULN;Serum total bilirubin are all <=1.5x ULN; 11.Patients can understand the research process, voluntarily join the study, sign informed consent, and have good compliance and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who are pregnant or breastfeeding, women of childbearing age who refuse to take effective contraceptive measures during the study period; those with peripheral nervous system disorders caused by diseases or those with a history of obvious mental disorders and central nervous system disorders; 2. Severe or uncontrolled infections that may affect the study treatment or the evaluation of the study results, including but not limited to: human immunodeficiency virus (HIV) antibody positive, etc.; 3. Those who are known to be allergic to the active ingredients or other ingredients of the study drug or have contraindications to surgery; 4. Except for cured skin basal cell carcinoma and cured cervical carcinoma in situ, the disease-free period of other cancers is less than 5 years; 5. According to the judgment of the investigator, during neoadjuvant therapy, other anti-tumor therapy (except ovarian function inhibitor) is required; 6. Patients who are participating in or participating in other clinical trials within one month; 7. Stage IV (metastatic) breast cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Frequency and severity of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhang Qiang
Liaoning Cancer Hospital
Outcome results
None listed