Mechanism Exploration of Anti-HER-2 Small-molecule Tyrosine Kinase Inhibitor-related Diarrhea and Establishment of Prevention and Treatment Model(Measure)
Breast Cancer
About this trial
This is an interventional prevention trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: Plan to take pyrrolidine or naratinib for ≥ 28 days; HER2 positive female patients with breast cancer aged ≥ 18 years and ≤ 65 years; Patients with the following treatment schemes: 1. Pirotinib/naratinib monotherapy 2. Pirotinib/naratinib combined endocrine therapy; 4. The ECOG score is 0-1; Life expectancy ≥ 6 months; Patients who followed diet intervention after enrollment; Volunteer to join the study, sign the informed consent form, have good compliance and are willing to cooperate with follow-up. Exclusion Criteria: People who may be allergic to pyrrolidine, naratinib or excipients; There are many factors that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting; Patients with biliary obstruction; Participate in other clinical trials related to diarrhea; Pregnant and lactating women, women with fertility and positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period; According to the judgment of the investigator, there are concomitant diseases (including but not limited to severe hypertension and severe diabetes beyond drug control) that seriously endanger the patient's safety or affect the patient's completion of the study; Have taken other drugs that may cause diarrhea adverse reactions within 3 weeks before enrollment; There are drugs with high probability of causing diarrhea adverse reactions in patients' combined medication; Any other situation in which the researcher believes that the patient is not suitable to participate in this study.
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Diarrhea group
No diarrhea group
Patients with diarrhea after taking pyrrolidine/naratinib,implement intervention (Yihuo 0.2g po bid+ Gold bifidum 2g po tid)
Patients without diarrhea after taking pyrrolidine/naratinib