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.
1 other identifier
interventional
336
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2024
CompletedFirst Submitted
Initial submission to the registry
September 25, 2024
CompletedFirst Posted
Study publicly available on registry
September 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedSeptember 27, 2024
September 1, 2024
1.3 years
September 25, 2024
September 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of febrile neutropenia for chemotherapy cycle 1.
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.
21 days (Cycle 1 of chemotherapy treatment)
Study Arms (2)
24h group
EXPERIMENTAL48h group
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2024
First Posted
September 27, 2024
Study Start
September 19, 2024
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
September 27, 2024
Record last verified: 2024-09