RecruitingPhase 4

Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints

China336 participantsStarted 2024-09-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The incidence of febrile neutropenia for chemotherapy cycle 1.

Timeframe: 21 days (Cycle 1 of chemotherapy treatment)

Trial details

NCT IDNCT06616571

SponsorQilu Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-30

Contact for this trial

Mengli Zhu, Master

13256715221 mengli.zhu@qilu-pharma.com

View on ClinicalTrials.gov More Chemotherapy-Induced Febrile Neutropenia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.