Comparing QL0605 Injections Timing for Breast Cancer Patients
A Randomized, Open-label, Interventional, Real-world Study to Compare the Efficacy and Safety of QL0605 Administered at Different Timepoints After Chemotherapy.
This study is testing whether giving QL0605 injections 24 hours or 48 hours after chemotherapy helps breast cancer patients avoid serious side effects like fever and low white blood cell counts.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qilu Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06616571 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of QL0605 injections administered either 24 hours or 48 hours after chemotherapy in patients with invasive breast cancer. It is a multicenter, open-label, randomized trial where patients are assigned to one of the two timing groups. The primary focus is on the incidence of febrile neutropenia following the first cycle of chemotherapy, while secondary outcomes include rates of severe neutropenia, chemotherapy dose adjustments, and related complications. The study seeks to determine the optimal timing for administering QL0605 to enhance patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with invasive breast cancer scheduled for specific chemotherapy regimens.
Not a fit: Patients with known hypersensitivity to rhG-CSF or those currently pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of chemotherapy-induced febrile neutropenia, leading to better patient outcomes and reduced complications.
How similar studies have performed: Other studies have shown promising results with similar approaches to managing chemotherapy-induced side effects, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jinan, Shandong
- Shandong Cancer Hospital — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Mengli Zhu, Master
- Email: mengli.zhu@qilu-pharma.com
- Phone: 13256715221
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.