Breast cancer
Conditions
Interventions
Test group:Pyrotinib Maleate Tablets
Sponsors
Baotou Tumor Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18-75 years; 2. ECOG score: 0-1; 3. The primary invasive lesions and lymph nodes of the breast must meet the following conditions at the same time: (1) Histologically confirmed invasive breast cancer; (2) Has received radical resection or breast conserving surgery for breast cancer: Patients who have received breast conserving surgery must be confirmed by pathological examination that there is no residual invasive cancer and ductal carcinoma in situ at the cutting edge; The incisional margin allows lobular carcinoma in situ to remain; (3) For patients who did not receive neoadjuvant therapy, postoperative pathological examination showed lymph node metastasis (including lymph node micrometastasis); In patients receiving neoadjuvant therapy, postoperative pathology showed that there were invasive cancer residues in breast or axillary lymph nodes; (4) The result of HER2 pathological test is positive, which is defined as the result of immunohistochemistry (IHC) is 3+ or the result of in situ hybridization (ISH) is HER2 gene amplification (HER2 / CEP17 >= 2.0 or average HER2 copy number / cell >= 6); (5) There were no recurrent and metastatic diseases after operation; 4. If receiving neoadjuvant therapy in the past, at least 4 cycles of treatment must be completed, and the medication scheme must include chemotherapy and anti-HER2 treatment; 5. Trastuzumab or trastuzumab + patuzumab treatment for >= 24 weeks (8 dosing cycles) has been completed in the neoadjuvant and / or adjuvant treatment stage, and the time interval from the end of the last trastuzumab treatment course to entering this study must be = 1.5 x 10^9/L 2) platelet count (PLT) >= 90 x 10^9/L 3) hemoglobin (Hb) >= 90 g/L; (2) Blood biochemistry 1) total bilirubin (TBIL) = 55%; (4) 12 lead ECG: fridericia corrected QT interval (QTCF) < 470 msec. 8. Female patients without menopause or surgical sterilization: agree to abstinence or use effective non hormonal contraceptive methods during the study treatment and within 8 weeks after the last administration in the study treatment; 9. Voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Local or regional recurrent breast diseases have occurred in the past; 2. The clinical stage of the tumor is stage IV (metastatic) breast cancer; 3. Bilateral breast cancer; 4. History of any malignant tumor other than breast cancer in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma; 5. Previous treatment including pyrrolotinib, lapatinib, naratinib or other tyrosine kinase inhibitors, ADO trastuzumab emtansine (T-DM1), as well as other antitumor biotherapy or tumor immunotherapy; 6. Receive anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy; 7. The patient has received major surgery unrelated to breast cancer within 4 weeks before randomization, or the patient has not fully recovered from such surgery; 8. The cumulative use of anthracycline drugs in neoadjuvant / adjuvant treatment exceeds the following provisions: the cumulative dosage of doxorubicin exceeds 400 mg/m2; The cumulative dosage of epirubicin exceeds 800 mg/m2 (if other anthracyclines are used, this amount shall be converted); 9. Serious heart disease or discomfort, including but not limited to the following diseases: (1) Confirmed 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 drugs; (4) Heart valve disease with clinical significance; (5) ECG showed transmural myocardial infarction; (6) The blood pressure of patients with hypertension is poorly controlled by drugs (systolic blood pressure > 180 mmHg and / or diastolic blood pressure > 100 mmHg); 10. Inability to swallow, intestinal obstruction or other factors affecting drug administration and absorption; 11. Previous history of confirmed neurological or mental disorders, including patients without autonomous behavior ability or suffering from mental illness; 12. Previous history of gastrointestinal diseases with diarrhea as the main symptom; 13. Those who are known to have a history of allergy to the drug components of this scheme; Have a history of immune deficiency, including HIV test positive, or suffer from other acquired and congenital immune deficiency diseases, or have a history of organ transplantation; 14. Female patients during pregnancy and lactation, female patients with fertility and positive baseline pregnancy test; 15. Suffering from serious concomitant diseases or other combined diseases that will interfere with the planned treatment, including infectious diseases with active infection, or any other circumstances that the investigator believes the patient is not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| invasive disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival;overall survival;Security; | — |
Countries
China
Contacts
Public ContactXiaorong Yuan
Baotou Tumor Hospital
Outcome results
None listed