Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints
A Randomized, Open-label, Interventional, Real-world Study to Compare the Efficacy and Safety of QL0605 Administered at Different Timepoints After Chemotherapy.
Qilu Pharmaceutical Co., Ltd.
336 participants
Sep 19, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria6
- 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.
Interventions
Eligible patients are scheduled to receive 2 cycles of chemotherapy every three weeks. During each chemotherapy cycle QL0605 is injected 24 hours s.c. post chemotherapy application.
Eligible patients are scheduled to receive 2 cycles of chemotherapy every three weeks. During each chemotherapy cycle QL0605 is injected 48 hours s.c. post chemotherapy application.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06616571