Breast cancer
Conditions
Interventions
Case series:Tiepefigastine injection
Sponsors
Quanzhou First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Patients with a definite diagnosis of breast cancer by pathology or imaging and selected a two-week or three-week chemotherapy regimen with a medium-high risk of FN; 3. ECOG score 0-2; 4. Expected survival >=12 weeks; 5. Patients who are willing to receive the prophylactic use of thiepefigastine after chemotherapy; 6. No serious dysfunction of heart, lung, liver, kidney and other important organs; No jaundice or obstruction of digestive tract; No acute infection was associated; 7. Hematological examination should meet the following standards: ANC>=1.0x10^9/L; Hb>=70g/L; PLT>=75x10^9/L; 8. Biochemical tests should meet the following criteria: ALT and AST<=2.5xULN; TBIL<=1.5xULN; serum creatinine<=1.5xULN; 9. Women of childbearing age must have a pregnancy test (serum) within 7 days before enrolment, and the results should be obtained is negative and is willing to use an appropriate method of contraception during the trial and for 8 weeks after the last administration of the experimental drug; For men, surgical sterilization or consent to use an appropriate method of contraception during the trial and for 8 weeks after the last administration of the experimental drug; 10. Patients volunteered to participate in this study, signed informed consent, and showed good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to this product or other biological products derived from genetically engineered Escherichia coli; 2. Received treatment with polyethylene glycol recombinant human granulocyte stimulating factor (PEG-rhG-CSF) and this product within 14 days before enrollment; 3. Accompanied by severe heart, liver and kidney diseases; neurological and mental diseases; or uncontrolled clinical symptoms or diseases of the heart; 4. There are serious concomitant diseases judged by the researchers to affect the safety and compliance of the study; 5. Active infection or unexplained fever > 38.5 ? during the screening period and before the first administration (According to the investigator's judgment, subjects with fever due to tumor can be enrolled); 6. Have a history of drug addiction; 7. Breastfeeding patients; 8. Any patient with abnormal myeloid hyperplasia and other abnormal hematopoietic function; 9. Those who cannot cooperate with follow-up and have poor compliance; 10. The researcher believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of degree >=3 neutropenia after tiepefigostim administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of neutropenic febrile syndrome (FN) after thiepefigastine administration;Incidence of delayed chemotherapy due to neutropenia after tiepefigastine administration;Incidence of dose reduction due to neutropenia after thiepefiglatin administration;Incidence and severity of adverse events (AE) and serious adverse events (SAE); | — |
Countries
China
Contacts
Public ContactChen Debo
Quanzhou First Hospital
Outcome results
None listed