Beeast cancer
Conditions
Interventions
Test group:Pyrotinib: 400 mg orally once daily within 30 minutes after breakfast, 1 cycle over 21 days for 6 cycles
Trastuzumab
D1, 8 mg/kg for Cycle 1 and 6mg/kg for Cycles 2-6, administered by intravenous infusion/subcutaneous injection, 1 cycle on 21 days, 6 cycles of continuous dosing.
Nab-paclitaxel: D1, D8 125 mg/m^2 adm
Sponsors
Huaihe Hospital of Henan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female initial treatment patients aged >= 18 years and = 1.5 × 10^9/L; PLT >=90×10^9/L; Hb >=90g/L; (2) Biochemical tests must meet the following criteria: TBIL = 50 mL/min (Cockcroft Gault formula); (3) Cardiac ultrasound and echocardiography: left ventricular ejection fraction (LVEF >= 55%); (4) 18 lead electrocardiogram with Fridericia corrected QT interval (QTcF) in females<470 ms; 6. For female patients who have not undergone menopause or surgical sterilization: agree to abstinence or use effective contraceptive methods for at least 7 months during the treatment period and after the last dose of the study treatment; 7. Voluntarily join this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer; 2. Inflammatory breast cancer; 3. Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding cured malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma; 4. Simultaneously undergoing anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonates therapy, or immunotherapy; 5. The patient has undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgical procedures; 6. Serious heart disease or discomfort, including but not limited to the following diseases: Diagnosed history of heart failure or systolic dysfunction (LVEF100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (i.e. Mobitz II second or third degree atrioventricular block) Angina pectoris requiring anti angina medication treatment Clinically significant heart valve disease ECG shows transmural myocardial infarction Poor control of hypertension (systolic blood pressure>180 mmHg and/or diastolic blood pressure>100 mmHg) 7. Inability to swallow, intestinal obstruction, or other factors that affect medication administration and absorption; 8. Those who are known to have a history of allergies to the components of this drug regimen; History of immunodeficiency, including HIV positive test results, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 9. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or reproductive age patients who are unwilling to take effective contraceptive measures during the entire trial period and within 7 months after the last study medication; 10. Suffering from serious accompanying diseases or other comorbidities that may interfere with the planned treatment, or any other circumstances that the researcher deems unsuitable for the patient to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Non invasive disease survival period;Event free survival period;Disease-free survival period;Survival period without distant metastasis;Overall survival;Safety indicators; | — |
Countries
China
Contacts
Public ContactMingde Ma
Huaihe Hospital of Henan University
Outcome results
None listed