breast cancer
Conditions
Interventions
Single arm group:Once daily becomes twice daily with no change in total dose
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Scheduled to take tyrosine kinase inhibitors for >= 60 days; 2.Female patients, Aged 18 to 75 years; 3.ECOG score of 0 to 1; 4.Patients with HER2 expression positive breast cancer confirmed by pathological testing; 5.Tyrosine kinase inhibitor use as the adjuvant intensive phase of treatment for HER2-positive breast cancer. 6.Tyrosine kinase inhibitor use as a single agent; 7.Voluntary enrollment in this study, signed informed consent, good compliance and willingness to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.May be allergic to tyrosine kinase inhibitors or excipients; 2.With multiple factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting; 3.Patients with biliary tract obstruction; 4.Participation in other diarrhea-related clinical trials; 5.Female patients who are pregnant or lactating, female patients of childbearing potential who test positive for a baseline pregnancy test or female patients of childbearing potential who are unwilling to use effective contraception throughout the duration of the trial; 6.At the investigator's discretion, have a serious concomitant medical condition that jeopardizes patient safety, or interferes with the patient's ability to complete the study (including, but not limited to, severe hypertension uncontrolled by medication, severe diabetes, etc.); 7.Have taken other medications within 3 weeks prior to enrollment that may cause adverse reactions to diarrhea; 8.Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 3 and above diarrhea;The dose is adjusted in proportion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median time to first onset of diarrhea;Median duration of diarrhea;Median time to first onset of grade 3 diarrhea;Median duration of grade 3 diarrhea;Other adverse events occurrence; | — |
Countries
China
Contacts
Public ContactChen Chuang
Renmin Hospital of Wuhan University
Outcome results
None listed