NCT04722978

Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Sun Yat-Sen University Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine and carboplatin plus antibiotic (moxifloxacin)	Standard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin)
DRUG	Gemcitabine combined with carboplatin plus placebo	Standard chemotherapy (gemcitabine and carboplatin) plus placebo

Timeline

• Start date: 2021-04-20
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2021-01-25
• Last updated: 2025-12-17

Locations

1 site across 1 country: China