NCT06616571

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.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy-Induced Febrile Neutropenia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-19
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2024-09-27
• Last updated: 2024-09-27

Locations

1 site across 1 country: China