Breast cancer
Conditions
Interventions
1:pyrotinib combined with EC-TH
Sponsors
Breast and Thyroid Surgery Department of the First Affiliated Hospital of Army Medical University, PLA
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female breast cancer patients aged =18 years and =70 years old; 2. According to the definition of the latest ASCO/CAP guidelines, histopathologically confirmed early-stage HER2-positive breast cancer, and meet the following conditions: ? Both pathological types HER2 positive, specifically: immunohistochemical (IHC) staining showed HER2 3+ and/or fluorescence in situ hybridization (FISH) positive (confirmed by the investigator of the trial center); ? Tumor stage: II- Stage III; 3. Have not received anthracycline, taxane chemotherapy, and anti-HER2 therapy; 4. ECOG score 0-1; 5. Expected survival period of not less than 12 weeks; 6. The patient has at least one measurable lesion Presence (RECIST1.1); 7. The functional level of the organ must meet the following requirements: a. Blood routine: Neutrophil (ANC) =1.5×109/L; Platelet count (PLT) =90×109/L; Hemoglobin (Hb) = 90 g/L; b. Blood biochemistry: total bilirubin (TBIL) = 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) )=1.5×ULN; alkaline phosphatase=2.5×ULN; urea or urea nitrogen (BUN) and creatinine (Cr)=1.5×ULN; c. Echocardiography: left ventricular ejection fraction (LVEF)=50%; d .12-lead ECG: Fridericia-corrected QT interval (QTcF) < 470 msec. 8. For non-menopausal or surgically sterilized female patients: during the treatment period and within 8 weeks after the last dose in the study treatment, agree to abstain from sex or use an effective non-hormonal drug contraceptive method; 9. The investigator believes that it is available 10. Voluntarily participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Tumor-related symptoms and treatment; 1) Inflammatory breast cancer patients; 2) Locally ruptured breast cancer patients; 3) Breast cancer patients with extensive chest wall invasion. 2. Concomitant diseases/history 1) Other active malignant tumors within 5 years or concurrently before signing the informed consent. Localized tumors that have been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, etc. can be enrolled; 2) Received major surgical operations unrelated to breast cancer within 4 weeks before enrollment, Or the patient has not fully recovered from such procedures (tissue biopsy and peripheral venipuncture insertion of a central venous catheter [PICC] required for diagnosis are permitted); 3. Pregnant or lactating women; 4. Unresolved Infection; 5. There is a third space effusion (such as massive pleural effusion and ascites) that cannot be controlled by drainage or other methods. 6. Severe heart disease or discomfort, including but not limited to the following diseases: a. History of heart failure or systolic dysfunction (LVEF100bpm, significant ventricular arrhythmia (such as ventricular tachycardia) or higher-grade AV block (ie Mobitz II second-degree AV block or third-degree AV block); c. Angina pectoris requiring antianginal drug treatment; d. Clinically significant heart valve disease; e. ECG showing transmural myocardial infarction f. Poorly controlled hypertension (systolic blood pressure>180mmHg and/or diastolic blood pressure>100mmHg) 7. Inability to swallow, intestinal obstruction or other factors that affect drug taking and absorption; 8. According to the investigator's judgment, there is a serious risk to the patient's safety, or concomitant diseases (including but not limited to hypertension, severe diabetes mellitus) that affect the patient's completion of the study , active infection, thyroid disease, etc.); 9. Known history of allergy to the drug components of this regimen; history of immunodeficiency, including HIV test positive, or other acquired or congenital immunodeficiency diseases, or organ History of transplantation; 10. Those who suffer from mental illness or abuse of psychotropic substances and cannot cooperate; 11. Those who are considered unsuitable for enrollment by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival;objective response rate;overall survival; | — |
Countries
China
Contacts
Public ContactJun Jiang
Outcome results
None listed