QL0605(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.
QL0605(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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
The incidence of febrile neutropenia for chemotherapy cycle 1. — 21 days (Cycle 1 of chemotherapy treatment) 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.
Trial sites (1)
Facility
City
Region
Status
Shandong Cancer Hospital
Jinan
Shandong
Recruiting
More Qilu Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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