Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616571
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Open-label Interventional Real-world Study to Compare the Efficacy and Safety of QL0605 Administered at Different Timepoints After Chemotherapy
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Patients with stage invasive breast cancer who were scheduled to receive at least 2 cycles of adjuvant or neoadjuvant chemotherapy with TACTCTCbH regimen were eligible for this multicenter open-label randomized trial Patients were randomized 21 to receive QL0605 24 hours 24h group or 48 hours 48h group after the end of each cycle of chemotherapy The primary endpoint was the incidence rate of FN for cycle 1 The secondary endpoints included the incidence rates of grade 34 neutropenia chemotherapy dose reduction and chemotherapy delay due to neutropenia antibiotic administration the pain bone muscle or joint ect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None