Breast cancer
Conditions
Interventions
Experimental group:Pyrotinib combined with TH
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female treatment-naive patients aged >=18 years and =1.5*10^9/L; PLT>=90*10^9/L; Hb>=90g/L; (2) Biochemical tests should meet the following criteria: TBIL=50 mL/min (CockcroftGault formula); (3) Cardiac ultrasound and echocardiography: left ventricular ejection fraction (LVEF>=55%); (4) 18-lead ECG with Fridericia-corrected QT interval (QTcF) in women <470 ms; 6. For premenopausal or surgically sterilized female patients: Consent to abstinence or use of effective contraception during treatment and for at least 7 months after the last dose of study treatment; 7. Voluntarily joined the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer; 2. inflammatory breast cancer; 3. Received antitumor 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; 4. Concurrently receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy; 5. Has undergone major surgical procedures not related to breast cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures; 6. Serious heart disease or discomfort, including but not limited to the following: (1) Diagnosed history of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmia (eg, ventricular tachycardia), or higher-grade AV block (ie, Mobitz II second-degree AV block or third-degree AV block); (3) Angina pectoris requiring antianginal drug treatment; (4) Clinically significant heart valve disease; (5) ECG showing transmural myocardial infarction; (6) Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg); 7. Inability to swallow, bowel obstruction, or other factors that interfere with drug taking and absorption; 8. Known history of allergy to the drug components of this regimen; history of immunodeficiency, including HIV positive test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 9. Pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial period and within 7 months after the last study drug; 10. Have serious comorbidities or other comorbidities that would interfere with planned treatment, or any other condition that the investigator considers the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival;Disease-free survival;Distant metastasis-free survival;Objective Response Rate;Drug-related safety indicators; | — |
Countries
China
Contacts
Public ContactPengwei Lv
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed