Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722978
Status:
RECRUITING
Last Update Posted:
2022-11-08
First Post:
2021-01-21
Brief Title:
Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer a Multicenter Double-blind Placebo-controlled Phase 3 Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to compare progression-free survival PFS of patients with metastatic triple-negative breast cancer randomised to treatment with standard chemotherapy plus moxifloxacin or placebo
Detailed Description:
This is a multicenter randomised double-blind placebo-controlled phase 3 trial The main purposes of this study are to examine the efficacy and safety of standard chemotherapy plus moxifloxacin or placebo as first-line treatment in patients with metastatic triple-negative breast cancer This study is designed to recruit up to 228 subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None