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.
Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
Histologically confirmed invasive ductal carcinoma, no specific type (NOS)
ER negative and progesterone receptor (PR) negative (defined as < 1% positive cells by IHC), human epidermal growth factor receptor 2 (HER2) negative (defined as IHC 0-1 staining or fluorescent in situ hybridization (FISH) negative).
No prior therapy after first recurrence or diagnosis of metastatic disease.
Pregnant or breast feeding.
Definitive breast cancer susceptibility gene (BRCA) mutation, Programmed Cell Death-Ligand 1 (PD-L1) positive, microsatellite instability-high (MSI-H), and mismatch repair deficient (dMMR).
Patients who are receiving or will receive other biological agents or immunotherapy.
Uncontrolled medical problems.
Parallel
Gemcitabine and carboplatin plus antibiotic (moxifloxacin)
DrugStandard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin)
Gemcitabine combined with carboplatin plus placebo
DrugStandard chemotherapy (gemcitabine and carboplatin) plus placebo
progression-free survival (PFS)
The interval from the date of randomization until the first date on which progression, or death due to any cause
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