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.

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-Induced Febrile Neutropenia
• Intervention / Treatment: Drug: QL0605(PEG-rhG-CSF); Drug: QL0605(PEG-rhG-CSF)

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.

• Study Type: Interventional
• Enrollment (Estimated): 336
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wangwang Zhi, Master; Phone Number: 17761716313; Email: wangwang.zhi@qilu-pharma.com
• Study Contact Backup: Name: Mengli Zhu, Master; Phone Number: 13256715221; Email: mengli.zhu@qilu-pharma.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital
      • Contact: Wangwang Zhi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 24h group	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.
Active Comparator: 48h group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Febrile Neutropenia, Breast Cancer, Chemotherapy
• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Cytopenia; Neutropenia; Febrile Neutropenia; Chemotherapy-Induced Febrile Neutropenia
• Other Study ID Numbers: QL0605-401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No