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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
228
Standard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin)
Standard chemotherapy (gemcitabine and carboplatin) plus placebo
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGprogression-free survival (PFS)
The interval from the date of randomization until the first date on which progression, or death due to any cause
Time frame: 36 months
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