RecruitingPhase 4NCT06616571

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.


Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

336 participants

Start Date

Sep 19, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different timing schedules for giving QL0605 — a long-acting version of a white blood cell booster (a PEGylated G-CSF injection) — to help prevent dangerously low white blood cell counts in breast cancer patients receiving chemotherapy. The goal is to find the best time to give the injection to reduce infection risk. **You may be eligible if...** - You are 18 or older - You have invasive breast cancer confirmed by biopsy - You are planning to receive TAC, TC, or TCbH chemotherapy - Your blood counts and organ function are in good shape - Your life expectancy is more than 3 months - You are in reasonable overall health (ECOG score ≤ 2) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had chemotherapy or radiation within the last 4 weeks - You received a PEG-rhG-CSF injection within the last 6 weeks - You have an uncontrolled infection - You have a known allergy to G-CSF or PEG-G-CSF - You have another untreated cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQL0605(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.

DRUGQL0605(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.


Locations(1)

Shandong Cancer Hospital

Jinan, Shandong, China

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NCT06616571