diarrhea
Conditions
Interventions
control group:none
experimental group:the patient was administered pyrotinib concurrently with Xiangsha Liujun Pills (manufactured by Henan Wanxi Pharmaceutical Co. Ltd.) at a dosage of 12 pills taken orally three times
Sponsors
The Second Affiliated hospital of Guangzhou University of Chinese medicine(Guangdong Provincial Hospital of Chinese Medicine )
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Adult female patients (aged 18–80 years inclusive) with pathologically or radiologically confirmed breast cancer. 2) HER-2 positivity confirmed by pathological examination (HER-2 positive: defined as IHC 3+ or FISH positive). 3) Patients currently undergoing pyrotinib treatment. 4) WHO performance status of 0–2 with an expected survival of at least 3 months. 5) Prior treatment-related toxicities must have resolved to = Grade 1 per NCI CTCAE (v4.03) (except for alopecia or other toxicities deemed by the investigator to pose no safety risk). 6) Normal hematological test results within 1 week before enrollment: a. White blood cell count (WBC) = 3.0 × 10?/L b. Absolute neutrophil count (ANC) = 1.5 × 10?/L c. Platelet count (PLT) = 100 × 10?/L. 7) Normal liver kidney and cardiac function test results within 1 week before enrollment (based on the normal ranges of each study centers laboratory): a. Total bilirubin (TBIL) = 1.5 × upper limit of normal (ULN) b. Alanine aminotransferase and aspartate aminotransferase (ALT/AST) = 2.5 × ULN (= 5 × ULN for patients with liver metastases) c. Serum creatinine = 1.5 × ULN or creatinine clearance (Ccr) = 60 mL/min d. Left ventricular ejection fraction (LVEF) = 55% e. QTcF (Fridericia correction) = 470 ms.
Exclusion criteria
Exclusion criteria: 1) Patients with visceral crisis. 2) Patients who have difficulty swallowing chronic diarrhea or intestinal obstruction or have multiple factors affecting drug administration and absorption. 3) Participation in another drug clinical trial within 4 weeks prior to enrollment. 4) History of other malignancies within the past 5 years except for cured carcinoma in situ of the cervix basal cell carcinoma of the skin or squamous cell carcinoma of the skin. 5) Known hypersensitivity to any component of the study drugs. 6) History of immunodeficiency including HIV-positive status HCV infection or other acquired/congenital immunodeficiency diseases or history of organ transplantation. 7) Severe cardiac disease or conditions including but not limited to: History of heart failure or systolic dysfunction (LVEF 100 bpm significant ventricular arrhythmias such as ventricular tachycardia or high-grade atrioventricular block [i.e. Mobitz II second-degree or third-degree AV block]); Angina requiring anti-anginal medication; Clinically significant valvular heart disease; ECG evidence of transmural myocardial infarction; Poorly controlled hypertension (systolic BP > 180 mmHg and/or diastolic BP > 100 mmHg). 8) Pregnant or lactating women or women of childbearing potential with a positive baseline pregnancy test. 9) Any concomitant illness that in the investigators judgment seriously endangers patient safety or compromises study completion. 10) History of significant neurological or psychiatric disorders including epilepsy or dementia. 11) Any other condition that in the investigators opinion makes the patient unsuitable for the study including interfering comorbidities or circumstances or any severe medical condition that may jeopardize patient safety (e.g. uncontrolled cardiac disease hypertension active or uncontrolled infections).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of diarrhea; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of diarrhea onset;Time to recovery to = Grade 1 diarrhea;Pyrotinib dose adjustment or treatment discontinuation rate;Duration of diarrhea;Comparison of cumulative loperamide doses administered in both arms after therapy; | — |
Countries
China
Contacts
Public ContactQianjun ChenLiping Ren
The Second Affiliated hospital of Guangzhou University of Chinese medicine(Guangdong Provincial Hospital of Chinese Medicine )
Outcome results
None listed