Clinical trial · Interventional
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
NCT04722978CI-TRIAL-00099111recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine and carboplatin plus antibiotic (moxifloxacin) | Drug | — | UNRESOLVED |
| Gemcitabine combined with carboplatin plus placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Experimental group
- description
- Gemcitabine combined with carboplatin plus moxifloxacin
- interventionNames
- Drug: Gemcitabine and carboplatin plus antibiotic (moxifloxacin)
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- Gemcitabine combined with carboplatin plus placebo
- interventionNames
- Drug: Gemcitabine combined with carboplatin plus placebo
Primary outcomes (1)
- measure
- progression-free survival (PFS)
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.