neutropenia
Conditions
Interventions
Case series:NA
Sponsors
Chinese People's Liberation Army (PLA)-307th Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with breast cancer confirmed by pathological histology or cytology, and deemed suitable by the investigator to receive a 21-day cycle containing anthracycline and/or taxane chemotherapy regimens for neoadjuvant or adjuvant therapy, and who will subsequently receive at least two cycles of chemotherapy; 2. Body weight = 45 kg; 3. Age = 18 years and = 80 years; 4. ECOG score = 2; 5. Routine blood test: Hemoglobin = 90 g/L, white blood cell count = 4.0 × 10^9/L, platelet count = 100 × 10^9/L, neutrophil count = 2.0 × 10^9/L; 6. Voluntarily participate in this clinical trial, understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects had received or are anticipated to receive extensive radiotherapy (>25% of the total bone marrow volume) within 2 months prior to screening. 2. Lack of insight or ability to describe their medical condition; 3. Uncontrolled infection or use of antibiotics within 72 hours prior to screening; 4. History of or current bone marrow or organ transplantation; 5. Clinical, electrocardiographic, or other diagnostic evidence of acute congestive heart failure, cardiomyopathy, or myocardial infarction; 6. Presence of any disease that may lead to splenomegaly; 7. Substance or alcohol abusers; 8. Known hypersensitivity to G-CSF or excipients of the medication; 9. Use of other investigational drugs within 1 month prior to screening or still within 5 half-lives of the drug (whichever is longer); 10. Investigators believe that the patient has a disease or symptom that makes them unsuitable for this study, and the study medication may harm the patient's health or affect the judgment of adverse events.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade = 3 neutropenia (ANC< 1.0× 109/L)in the first cycle.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of grade 3 (ANC < 1.0 × 10^9/L) or higher neutrophil count reduction during cycles 2 to 4.;The incidence of grade 4 (ANC < 0.5 × 10^9/L) neutrophil count reduction across cycles 1 to 4;The incidence of febrile neutropenia (FN) across cycles 1 to 4.;The proportion of patients receiving antibiotic treatment and experiencing infections across cycles 1 to 4.; | — |
Countries
China
Contacts
Public ContactJiang Zefei
Chinese People's Liberation Army (PLA)-307th Hospital
Outcome results
None listed