Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints

Recruiting now · Phase 4

Conditions studied: Chemotherapy-Induced Febrile Neutropenia

In brief

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.

Key facts

Study ID

NCT06616571

Run by

Qilu Pharmaceutical Co., Ltd.

People needed

336

Starts

2024-09-19

Expected to finish

2025-12-30

Last updated by the study team

2024-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Shandong Cancer Hospital — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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