Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer : a Multicenter, Double-blind, Placebo-controlled, Phase 3 Trial
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.
• At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
• Neutrophil-to-lymphocyte ratios (NLR) in peripheral blood ≥ 2.
• Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve (Left ventricular ejection fraction (LVEF) by echocardiogram ≥45%).
• Compliance with the study protocol.
• Have provided written and signed informed consent.