breast cancer
Conditions
Interventions
Group 1:Loperamide monotherapy
Group 2:Probiotics
Group 3:Probiotics combined with loperamide
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Plan to take pyrotinib for >= 28 days; 2. Female patients with HER2-positive breast cancer, aged 18-65 years; 3. Patients whose treatment plan is pyrotinib combined with capecitabine; 4. ECOG score of 0 to 1; 5. Life expectancy >= 6 months; 6. Patients who obey dietary intervention after enrollment; 7. Voluntarily join the study, sign the informed consent, have good compliance and be willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. There are various factors that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting, etc.; 2. Patients with biliary obstruction; 3. Participate in other diarrhea-related clinical trials; 4. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial; 5. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, etc.); 6. Have taken other drugs that may cause diarrhea adverse reactions within 3 weeks before enrollment; 7. There is a high probability of causing diarrhea adverse reactions in the patient's concomitant medication; 8. Plan to take antibacterial drugs within 3 weeks before enrollment and during the trial period; 9. Any other conditions in which the researcher believes that the patient is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 3 or higher diarrhea; | — |
Countries
China
Contacts
Public ContactWang Shusen
Outcome results
None listed