Breast cancer
Conditions
Interventions
Test group:Trastuzumab + pyrotinib + capecitabine
Control group:Continuation of original neoadjuvant therapy
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent; 2. Female breast cancer patients aged 18 to 75 years; 3. ECOG score of 0 to 1; 4. Breast cancer meets the following criteria: (1) Histologically or pathologically confirmed invasive breast cancer, the primary tumor stage determined by the standard evaluation method in the research center: cT1-4/N0-3/M0; (2) HER2 expression-positive breast cancer confirmed by pathology, defined as >10% immunoreactive cells with an immunohistochemistry (IHC) score of 3+ or an in situ hybridization (ISH) result of HER2 gene amplification (HER2 gene signal and Centromere 17 signal ratio >= 2.0 or HER2 gene copy number >= 6); (3) Known hormone receptor status (ER and PgR); 5. Neoadjuvant therapy (including: at least 9 weeks of trastuzumab therapy and at least 9 weeks of taxane chemotherapy) is required for at least 6 cycles (the treatment duration lasts for more than 16 weeks); Note: HER-2 targeted therapy can be performed concurrently with chemotherapy; patients are allowed to use more than one HER-2 targeted drug; patients are allowed to use anthracyclines; 6. The pathology department after neoadjuvant therapy confirmed the presence of primary breast cancer or invasive cancer in the lymph nodes (residual invasive lesions of breast cancer > 2cm as assessed by the central laboratory or positive axillary lymph nodes with macrometastases); 7. Surgical resection must meet the following conditions: (1) Breast surgery: total mastectomy, histologically negative for invasive tumors at the resection margin; breast-conserving surgery, histologically negative at the resection margin; (2) For patients undergoing breast-conserving surgery, the margin of the excised specimen must be negative for invasive tumor histology; if the margin of resection is positive, additional surgery can be performed to obtain a negative result of the margin, otherwise total mastectomy is required, but Patients with positive resection margins for carcinoma in situ do not require additional resection. (3) Lymph node surgery: lymph node positive patients need axillary lymph node dissection; lymph node negative patients do not need axillary lymph node dissection 8. The interval between the end of surgery (without postoperative radiotherapy) and the time of randomization should not exceed 12 weeks or the interval between the end of postoperative radiotherapy and the time of randomization should not exceed 6 weeks; 9. The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks before screening, no use of white blood cell and platelet-raising drugs): (1) Blood routine; Neutrophil (ANC)>=1.5x10^9/L; Platelet count (PLT) >=90x10^9/L; Hemoglobin (Hb) >=90 g/L; (2) Blood biochemistry: total bilirubin (TBIL) = 55%; (4) 12-lead ECG: QT interval (QTcF) = 6 months; 12. Good compliance.
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; 4. At the same time receiving anti-tumor therapy in other clinical trials, including bisphosphonate therapy or immunotherapy (except for radiotherapy and endocrine therapy during treatment); 5. Received any anti-tumor therapy within 28 days before enrollment; 6. Peripheral neuropathy of grade >= 2 specified by NCI CTCAE; 7. Previously treated with pyrotinib or other anti-HER2 tyrosine kinase inhibitor drugs 8. Previously received the following cumulative doses of anthracyclines: doxorubicin>240mg/m2; epirubicin>480mg/m2; other anthracyclines, the same dose as doxorubicin>240mg/m2; 9. Received major surgical procedures unrelated to breast cancer within 4 weeks before randomization, or the patient has not fully recovered from such surgical procedures; 10. Severe heart disease or discomfort, including but not limited to the following diseases: (1) History of diagnosis of heart failure or systolic dysfunction (LVEF100 bpm, significant ventricular arrhythmia (eg, ventricular tachycardia) or higher-grade atrioventricular block (ie Mobitz II second-degree AV block or third-degree AV block); (3) angina pectoris; (4) Clinically significant heart valve disease; (5) ECG showed transmural myocardial infarction; (6) Any other heart disease that is judged by the investigator to be inappropriate to participate in this trial; 11. Poorly controlled hypertension after drug treatment (systolic blood pressure>180 mmHg and/or diastolic blood pressure>100 mmHg); 12. Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of drugs; 13. Known deficiency of dihydropyrimidine dehydrogenase (DPD); 14. Those who are known to have a history of allergies to the drug components of this regimen; have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 15. Any known liver disease, including infectious diseases with active infection, autoimmune liver disease and sclerosing cholangitis; 16. Pregnant, lactating female patients, female patients with fertility and positive baseline pregnancy test, or during the study treatment and within 8 weeks after the last dose of study treatment, agree to abstinence or use effective non-hormonal drugs contraceptive method; 17. There are serious concomitant diseases or other comorbid diseases that will interfere with the planned treatment; 18. Any other circumstances that the investigator considers inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year invasive disease free survival; | — |
Countries
China
Contacts
Public ContactWang Chuan
Fujian Medical University Union Hospital
Outcome results
None listed