Clinical trial · Interventional
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.
NCT06616571CI-TRIAL-00081125recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-Induced Febrile Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QL0605(PEG-rhG-CSF) | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 24h group
- interventionNames
- Drug: QL0605(PEG-rhG-CSF)
- type
- ACTIVE_COMPARATOR
- label
- 48h group
- interventionNames
- Drug: QL0605(PEG-rhG-CSF)
Primary outcomes (1)
- measure
- The incidence of febrile neutropenia for chemotherapy cycle 1.
- timeFrame
- 21 days (Cycle 1 of chemotherapy treatment)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.