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Clinical Trials in China / NCT04722978
Recruiting Phase 3

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

NCT04722978 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-Sen University Cancer Center
Phase
Phase 3
Started
2021-04-20
Last updated
2025-12-17

Condition(s) studied

Triple Negative Breast Cancer

Investigational drug(s) / intervention(s)

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

Gemcitabine and carboplatin plus antibiotic (moxifloxacin): Standard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin)

Gemcitabine combined with carboplatin plus placebo: Standard chemotherapy (gemcitabine and carboplatin) plus placebo

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04722978 on ClinicalTrials.gov ↗ ← All trials in China