breast cancer
Conditions
Interventions
Gold Standard:Pathological diagnosis
Index test:the concentration of acetylated rimantadine metabolites
Sponsors
The First Hospital Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Patient age > 18 years old; (2) Patients diagnosed with breast cancer by histopathology; (3) Physical status ECOG score (PS) is 0-1; (4) Organ function levels must meet the following requirements: Bone marrow: absolute neutrophil count (ANC) =1.5*109/L (1500/mm3), platelets =75*109/L, hemoglobin =9 g/dL. Liver: Serum bilirubin = 2 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 times the upper limit of normal value (AST is allowed if there is liver metastasis, ALT = 5 times the normal value) upper limit. Kidney: Serum creatinine =1.5 times the upper limit of normal. (5) There is no malabsorption or other gastrointestinal diseases that affect drug absorption; (6) Women of childbearing age must take a pregnancy test within 24 hours before enrollment and the result is negative; men of childbearing age: take contraceptive measures during and within 3 months after surgical sterilization or treatment; (7) Understand and voluntarily sign the written informed consent.
Exclusion criteria
Exclusion criteria: (1) Those who have received chemotherapy, radiotherapy and other anti-breast cancer treatments; (2) Patients with distant metastasis to the brain, bone, liver, etc.; (3) Have taken sulfonamides and anti-tuberculosis drugs (isoniazid, ethambutyric acid, para-aminosalicylic acid, isoniazid) within 4 weeks before administration; (4) History of cardiovascular disease: congestive heart failure > New York Heart Association (NYHA) class II. Patients with unstable angina (angina symptoms at rest) or new onset angina (onset within the last 3 months) or myocardial infarction within the last 6 months had to be excluded; (5) Known human immunodeficiency virus (HIV) infection; (6) Clinically severe infection >CTCAE grade 2 in active stage; (7) Patients who have undergone major surgery or suffered severe trauma within 3 weeks before enrollment; (8) Any situation that affects the patient’s ability to swallow drugs; (9) Any malabsorption situation; (10) The researcher believes that the subjects may not be able to complete this study or may not be able to comply with the requirements of this study (due to administrative reasons or other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the concentration of acetylated rimantadine metabolites; | — |
Countries
CHINA
Contacts
Public ContactHUI XIE
The First Hospital Affiliated Hospital of Nanjing Medical University
Outcome results
None listed