Mammary cancer
Conditions
Interventions
Single group:Pyrroltinib maleate tablets combined with trastuzumab plus docetaxel plus carboplatin
Sponsors
The First Affiliated Hospital of Suzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female patients with newly diagnosed breast cancer aged over 18 years old; 2. Patients with ECoG grade 0-1; 3. For patients with histologically confirmed invasive breast cancer, the primary tumor diameter measured by the standard evaluation method in the research center was > 2cm; 4. For breast cancer patients with positive HER2 expression confirmed by pathological examination, positive HER2 expression refers to standard immunity histochemical (IHC) staining showed that HER2 was 3 + and / or positive by fluorescence in situ hybridization (FISH); 5. Patients with known hormone receptor status (ER and PGR); 6. The functional level of main organs must meet the following requirements (no blood transfusion, no use of leukocyte and platelet raising drugs within 2 weeks before screening) (1) Blood routine Neutrophil (ANC) >= 1.5 x 10 9 / L; Platelet count (PLT) >= 90 x 10 9 / L; Hemoglobin (HB) >= 90 g / L; (2) Blood biochemistry Total bilirubin (TBIL) = 55%; (4) 12 lead ECG The QTCF corrected by fridericia method was less than 470 msec. 7. For women who are not postmenopausal or who have not undergone surgical sterilization: consent to abstinence or use effective contraceptive methods during treatment and at least 7 months after the last administration in the study 8. The patients who voluntarily joined the study signed informed consent, had good compliance and were willing to cooperate with the 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 evaluation of PCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| EFS;DFS;DDFS;ORR;AE; | — |
Countries
China
Contacts
Public ContactGuo Zhaoji
The First Affiliated Hospital of Suzhou University
Outcome results
None listed