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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorSun Yat-Sen University Cancer Center

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Gemcitabine and carboplatin plus antibiotic (moxifloxacin)
  • Gemcitabine combined with carboplatin plus placebo

Treatment groups

228 Participants
are divided into 2 treatment groups