breast cancer
Conditions
Interventions
Case series:pyrotinib maleate tablets combined with paclitaxel for injection (albumin-binding)
Sponsors
The Tumor Hospital of Liaoning Province, Breast Internal Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent; 2. Aged 18-75 years old female; 3. ECOG score 0-1; 4. Pathologically confirmed advanced breast cancer patients with positive HER-2 expression; 5. Histological and/or cytological confirmed invasive breast cancer, including locally advanced or metastatic breast cancer; 6. In the past, paclitaxel-containing drugs (except paclitaxel-albumin-binding for injection) and/or anthracycline-containing drugs have been used in adjuvant therapy or in the treatment of locally advanced/metastatic breast cancer; 7. According to RECIST 1.1, there is at least one measurable lesion; 8. The number of chemotherapy lines is less than or equal to 2 lines, and whether trastuzumab has been used in the past is not limited; 9. More than 3 months expected survival time; 10. There are enough organ functions. The laboratory test results within 7 days before admission should meet the following requirements: (1) blood routine test: WBC (> 3.0 *10^9/L), ANC (> 1.5 *10^9/L), PLT (> 100 *10^9/L), Hb (> 90 g/L); (2) Biochemical examination: TBIL < 1.5 times normal value upper limit (ULN); ALT and AST < 3 times ULN; ALT and AST < 5 times ULN for patients with liver metastasis; alkaline phosphatase < 3 times ULN, when combined with bone metastasis < 5 times ULN: BUN and CR < 1 times ULN and creatinine clearance rate < 50 mL/min (Cockcroft Gault formula); (3) Coagulation function: International normalized ratio (INR) = 1.5 times ULN; Activated partial thromboplastin time (APTT) = 1.5 times ULN; (4) Left ventricular ejection fraction (LVEF) of color Doppler echocardiography was greater than 50%; (5) Quantitative trait intervals (QTcF) corrected by 12-lead electrocardiogram Fridericia method were < 450 ms for males and < 470 MS for females.
Exclusion criteria
Exclusion criteria: 1. Patients with brain metastasis and extensive meningitis metastasis; 2. There is a third space effusion (e.g. massive pleural effusion and ascites) that cannot be controlled by drainage or other methods; 3. Those who received whole brain radiotherapy, chemotherapy, major surgery or molecular targeted therapy within 2 weeks before admission, and those who received endocrine therapy within 2 weeks before admission; 4. Participated in clinical trials of other new drugs within 4 weeks before admission; 5. Tyrosine kinase inhibitors targeting HER-2 (including lapatinib, neratinib and pyrotinib) have been or are being used in the past; 6. Other malignant tumors in the past five years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma; 7. Receive any other antineoplastic treatment at the same time; 8. Those who has a history of human immunodeficiency virus; 9. There are clinically significant active infections requiring treatment: hepatitis B (positive core antibody or hepatitis B surface antigen, HBV-DNA > 1000 cps/mL) or hepatitis C (positive results of hepatitis C antibody and/or HCV-RNA ); 10. Researchers believe that underlying diseases or uncontrolled systemic severe diseases will increase the risk of drug use. Major surgical procedures were performed within 4 weeks of the screening period or were expected to be performed during the study period; 11. Uncontrolled hypertension (systolic pressure > 150 mmHg and/or diastolic pressure > 100 mmHg) or unstable angina pectoris. Severe arrhythmias requiring treatment (except atrial fibrillation and paroxysmal supraventricular tachycardia) and has a history of chronic heart failure that meets the New York Heart Association (NYHA) criteria; History of myocardial infarction 6 months before randomization. LVEF was lower than 50% during or after trastuzumab treatment; 12. Female patients during pregnancy and lactation, those with fertility and positive baseline pregnancy test, or those of reproductive age who are unwilling to take effective contraceptive measures during the whole trial period; 13. It is known that there is a history of allergy to the ingredients in this trial; 14. Long-term daily oral (including inhalation) of glucocorticoid (equivalent to > 10mg/d methylprednisolone); 15. Non-hematological toxicity (> grade 2) that had not been recovered in previous treatments, and peripheral neuropathy (> grade 2) existed; 16. Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption; 17. Researchers believe that patients are not suitable for any other situation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Countries
China
Contacts
Public ContactTao Sun
The Tumor Hospital of Liaoning Province
Outcome results
None listed