Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints

Launched by QILU PHARMACEUTICAL CO., LTD. · Sep 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called QL0605, which is an injection given to patients after they receive chemotherapy for breast cancer. The study aims to find out whether giving QL0605 24 hours or 48 hours after chemotherapy works better and is safer for patients. This is especially important for people who may experience a condition called febrile neutropenia, which is when their white blood cell count drops and they develop a fever, making them more vulnerable to infections.

To participate in this trial, you need to be at least 18 years old and have a diagnosis of invasive breast cancer. You should also be planning to receive specific types of chemotherapy, and your overall health should be stable, meaning your blood, liver, lungs, and kidneys are functioning well. If you join the study, you will receive either the 24-hour or 48-hour injection after your chemotherapy and will be monitored for how well the treatment works and if there are any side effects. It's important to note that some people may not be eligible, such as those who are pregnant or have had other serious health issues recently. If you have any questions or need more details, the study team is available to help!

Gender

ALL

Eligibility 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.