NCT04722978RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 228 (estimated)
- First submitted
- 21 Jan 2021
- Start date
- 20 Apr 2021
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Sun Yat-Sen University Cancer Center
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT04722978
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 228
- From 20 Apr 2021 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are receiving or will receive other biological agents or immunotherapy.
Other illness
- 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).
- 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
Other
- Pregnant or breast feeding.
- Uncontrolled medical problems.
- Patients were unable or unwilling to comply with program requirements.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.