Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer
Recruiting · NCT04722978 · Interventional (participants receive a specific treatment) · Lead sponsor: Sun Yat-Sen University Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
Gemcitabine and carboplatin plus antibiotic (moxifloxacin)Gemcitabine combined with carboplatin plus placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Evidence of active acute or chronic infection.
- Hepatic, renal, cardiac, or bone marrow dysfunction as detailed above.
- Concurrent malignancy or history of other malignancy within the last five years.
- Known severe hypersensitivity to moxifloxacin
- Patients were unable or unwilling to comply with program requirements.
Where it is running
1 location listed.
- Sun Yat-sen University Cancer Center - Guangzhou, Guangdong, China