Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QL0605(PEG-rhG-CSF), QL0605(PEG-rhG-CSF).
- Who it may be relevant to
- Registry conditions: Chemotherapy-Induced Febrile Neutropenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Open-label, Interventional, Real-world Study to Compare the Efficacy and Safety of QL0605 Administered at Different Timepoints After Chemotherapy.
Overview
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.
Interventions
- Drug QL0605(PEG-rhG-CSF)
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. - Drug QL0605(PEG-rhG-CSF)
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.
Primary outcome measures
- The incidence of febrile neutropenia for chemotherapy cycle 1. [Time frame: 21 days (Cycle 1 of chemotherapy treatment)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shandong Cancer Hospital — Jinan
Identifiers
NCT: NCT06616571 · QL0605-401