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Compares treatment options for Chemotherapy-Induced Febrile Neutropenia
Official title Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints
ClinicalTrials.gov ID: NCT06616571
What this study is testing
What is QL0605(PEG-rhG-CSF)?
QL0605(PEG-rhG-CSF) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chemotherapy-induced febrile neutropenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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.
See the full eligibility 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;
- people with good hematology, liver, lung and kidney function ;
- Signed informed consent.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.