Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints
- Conditions
- Chemotherapy-Induced Febrile Neutropenia
- Interventions
- Drug: QL0605(PEG-rhG-CSF)
- Registration Number
- NCT06616571
- Lead Sponsor
- Qilu Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Patients with stage invasive breast cancer who were scheduled to receive at least 2 cycles of adjuvant or neoadjuvant chemotherapy with TAC/TC/TCbH regimen were eligible for this multicenter, open-label, randomized trial. Patients were randomized (2:1) to receive QL0605 24 hours (24h group) or 48 hours (48h group) after the end of each cycle of chemotherapy. The primary endpoint was the incidence rate of FN for cycle 1. The secondary endpoints included the incidence rates of grade 3/4 neutropenia, chemotherapy dose reduction and chemotherapy delay due to neutropenia, antibiotic administration, the pain (bone, muscle, or joint), ect.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 336
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 48h group QL0605(PEG-rhG-CSF) - 24h group QL0605(PEG-rhG-CSF) -
- Primary Outcome Measures
Name Time Method The incidence of febrile neutropenia for chemotherapy cycle 1. 21 days (Cycle 1 of chemotherapy treatment) Febrile neutropenia is defined as single temperature: ≥38.3 °C orally（axillary 38.1°C） or ≥38.0 °C（axillary 37.8°C） over 2h; and neutropenia: \<500 neutrophils/mcL.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China