Breast cancer
Conditions
Interventions
experimental group:Pyrotinib+Trastuzumab+Chemotherapy
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female breast cancer patients aged >= 18 years old; 2. ECOG score 0-1; 3. Histologically confirmed invasive breast cancer, the diameter of the primary tumor determined by the standard evaluation method in the research center is > 2cm; 4. HER2 expression-positive breast cancer confirmed by pathological examination, HER2 expression-positive refers to standard immunohistochemical (IHC) staining test showing that HER2 is 3+ and/or fluorescence in situ hybridization (FISH) positive (as approved by the investigator of the test center. audit confirmation); 5. Known hormone receptor status (ER and PgR); 6. The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks before screening, no use of leukocyte-raising and platelet-raising drugs) (1) Blood routine 1) Neutrophil (ANC)>=1.5x10^9/L; 2) Platelet count (PLT)>=90x10^9/L; 3) Hemoglobin (Hb) >= 90 g/L. (2) blood biochemistry 1) Total bilirubin (TBIL) = 55%; (4) 12-lead ECG with Fridericia-corrected QT interval (QTcF) < 470 msec. 7. For nonmenopausal or surgically sterilized female patients: consent to abstinence or use of effective contraceptive methods during treatment and for at least 7 months after the last dose in the study treatment; 8. Voluntarily join the study, sign the informed consent form, have good compliance and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with stage IV (metastatic) breast cancer; 2. Patients who have received anti-tumor therapy or radiotherapy for any malignant tumor in the past, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors; 3. Patients receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphate therapy or immunotherapy; 4. Patients who had undergone major operations unrelated to breast cancer within 4 weeks before randomization, or had not fully recovered from such operations; 5. Patients with severe heart disease or discomfort, including but not limited to the following diseases: (1) History of heart failure or systolic dysfunction (LVEF 100 BPM, significant ventricular arrhythmias (such as ventricular tachycardia) or higher grade atrioventricular block (i.e., mobitz II second degree atrioventricular block or third degree atrioventricular block); (3) Angina pectoris requiring anti angina medication; (4) Valvular heart disease with clinical significance; (5) ECG showed transmural myocardial infarction; (6) Poor control of hypertension (systolic blood pressure > 180 mmHg and / or diastolic blood pressure > 100 mmHg); 6. Patients who are unable to swallow, have intestinal obstruction or have other factors that affect the drug taking and absorption; 7. Patients with known allergic history to the drug components of this protocol, history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 8. Pregnant and lactating women, women with fertility and positive baseline pregnancy test, or women of childbearing age who were unwilling to take effective contraceptive measures during the whole trial period and within 7 months after the last study medication; 9. Patients with severe concomitant diseases or other comorbid diseases that may interfere with the planned treatment, or any other situation that the researcher considers that the patient is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete remission; | — |
Countries
China
Contacts
Public ContactZhang Jiaxin
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed