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Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints

RECRUITINGPhase 4Sponsored by Qilu Pharmaceutical Co., Ltd.
Actively Recruiting
PhasePhase 4
SponsorQilu Pharmaceutical Co., Ltd.
Started2024-09-19
Est. completion2025-12-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06616571

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions3

Breast CancerCancerChemotherapy-Induced Febrile Neutropenia

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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