Diarrhea
Conditions
Interventions
experimental group:Combination therapy with pyrotinib maleate tablets and traditional Chinese medicine formula
control group:Combination therapy with pyrotinib maleate tablets
Sponsors
China Medical University Shengjing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must meet all of the following inclusion criteria to be enrolled in this trial: 1) Aged 18 to 75 years with a confirmed diagnosis of breast cancer; 2) Subjects with HER2-positive breast cancer confirmed by histology [confirmed by the pathology laboratory as having an immunohistochemistry (IHC) score of 3+ or 2+ and positive in situ hybridization (ISH) test (ISH amplification rate = 2.0)]; 3) Subjects with advanced breast cancer requiring combination treatment with Pyrotinib Maleate Tablets; 4) No history of allergy to traditional Chinese medicine; 5) Time interval from the last treatment: (a) If the last treatment was endocrine therapy it should be = 2 weeks; (b) If the last treatment was chemotherapy it should be = 4 weeks; 6) ECOG performance score: 0 or 1; 7) Absolute neutrophil count = 1.5×109/L platelet count = 100×109/L hemoglobin = 90g/L; 8) Expected survival time = 3 months; 9) Voluntary signing of the written informed consent form. 2. Voluntary participation in this study signing the informed consent having good compliance and willingness to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1) Previous treatment with Pyrotinib Maleate Tablets and confirmed drug resistance; 2) History of allergy to traditional Chinese medicine; 3) Underlying digestive tract diseases (such as ulcerative colitis etc.); 4) Participation in other clinical trials within 4 weeks prior to enrollment; 5) Uncontrolled or significant cardiovascular diseases* including: a) Myocardial infarction within 12 months before screening; b) Uncontrolled angina pectoris within 6 months before screening; c) Congestive heart failure within 6 months before screening or left ventricular ejection fraction (LVEF) 450ms during the screening period; f) History of cerebrovascular accident; g) Symptomatic coronary artery disease requiring drug treatment. 6) Cardiac B-ultrasound shows a fluid dark area width in the pericardial cavity at the end of diastole = 10mm; 7) Received organ transplantation; 8) Toxicity from the previous treatment plan has not recovered and there are still grade 1 or higher toxic reactions within 4 weeks before screening; 9) Clinically significant gastrointestinal abnormalities that may affect drug intake transport or absorption (such as inability to swallow chronic diarrhea intestinal obstruction etc.); 10) Active infection Active bacterial viral fungal mycobacterial parasitic infection or other infections within 4 weeks before the screening period (excluding onychomycosis) or requiring intravenous antibiotic treatment or targeted antiviral treatment or any major infection event requiring hospitalization or continuous fever within 14 days before screening; 11) Less than 6 weeks after major organ surgery; 12) Abnormal liver function Total bilirubin > 1.5 times the upper limit of normal (for Gilbert's syndrome patients total bilirubin > 3 times the upper limit of normal); ALT/AST > 2.5 times the upper limit of normal for subjects without liver metastasis and ALT/AST > 5 times the upper limit of normal for subjects with liver metastasis; Abnormal renal function (serum creatinine > 1.5 times the upper limit of normal); 13) Currently or previously had other malignant tumors; 14) Any mental or cognitive disorders that may limit their understanding execution of the informed consent form and compliance with the study; 15) History of hypertension that cannot be stably controlled by medication as assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diarrhea incidence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Prevention of the first onset of diarrhea in the treatment of pirotinib maleate tablets with traditional Chinese medicine prescription;Prevention and application of traditional Chinese medicine prescription in the first time of grade 3 diarrhea in the treatment of pirotinib maleate tablets;Changes in Quality of Life Scale Scores;Cumulative Duration of Grade-3 Diarrhea in Pyrrolidine Maleate Tablets Treatment with Traditional Chinese Medicine Prevention;Changes in Cancer Nutrition Questionnaire Scores;Is there any statistical difference in syndrome differentiation of traditional Chinese medicine prescription in the combined treatment of pyrroltinib maleate tablets;Progress Free Survival;Overall Survival;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactKai Li
China Medical University Shengjing Hospital
Outcome results
None listed