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

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a multicenter, randomised, double-blind, placebo-controlled, phase 3 trial. The main purposes of this study are to examine the efficacy and safety of standard chemotherapy plus moxifloxacin or placebo as first-line treatment in patients with metastatic triple-negative breast cancer. This study is designed to recruit up to 228 subjects.

Official Title
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Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer : a Multicenter, Double-blind, Placebo-controlled, Phase 3 Trial

Conditions
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Triple Negative Breast Cancer

Intervention / Treatment
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* Drug: Gemcitabine and carboplatin plus antibiotic (moxifloxacin)
* Drug: Gemcitabine combined with carboplatin plus placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Gemcitabine combined with carboplatin plus moxifloxacin or placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental group<br>Gemcitabine combined with carboplatin plus moxifloxacin | Drug: Gemcitabine and carboplatin plus antibiotic (moxifloxacin)<br>* Standard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin)<br>* Other names: Gemcitabine 1000mg/m^2 IV on days 1 and 8; cycled every 21 days Carboplatin AUC 2 IV on days 1 and 8; cycled every 21 days Moxifloxacin 0.4 PO once daily days 1-5; cycled every 21 days;|
| Placebo Comparator: Control group<br>Gemcitabine combined with carboplatin plus placebo | Drug: Gemcitabine combined with carboplatin plus placebo<br>* Standard chemotherapy (gemcitabine and carboplatin) plus placebo<br>* Other names: Gemcitabine 1000mg/m^2 IV on days 1 and 8; cycled every 21 days Carboplatin AUC 2 IV on days 1 and 8; cycled every 21 days Placebo 0.4 PO once daily days 1-5; cycled every 21 days;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival (PFS) | The interval from the date of randomization until the first date on which progression, or death due to any cause | 36 months |