NCT06616571 Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints
| NCT ID | NCT06616571 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Chemotherapy-Induced Febrile Neutropenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 336 participants |
| Start Date | 2024-09-19 |
| Primary Completion | 2025-12-30 |
Trial Parameters
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Brief Summary
The goal of this real-world study is to compare the efficacy and safety of QL0605 administered 24 hours and 48 hours after chemotherapy in breast cancer patients.
Eligibility Criteria
Inclusion Criteria: * Aged≥18 years； * The expected survival period is more than 3 months; * ECOG≤ 2; * Invasive breast cancer diagnosed by histopathology; * Plan to receive TAC, TC or TCbH chemotherapy; * Subjects with good hematology, liver, lung and kidney function ; * Signed informed consent. Exclusion Criteria: * Known hypersensitivity to rhG-CSF or PEG-rhG-CSF; * Female patients during pregnancy or lactation; * The previous malignant tumors were not cured; * Received chemotherapy or radiotherapy within 4 weeks before screening; * Received PEG-rhG-CSF within 6 weeks before screening; * Suffering from uncontrollable infectious diseases within 2 weeks before screening.