Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer : a Multicenter, Double-blind, Placebo-controlled, Phase 3 Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) score of 0 to
- •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 ≥
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental group
Gemcitabine combined with carboplatin plus moxifloxacin
干预措施: Gemcitabine and carboplatin plus antibiotic (moxifloxacin) (Drug)
Control group
Gemcitabine combined with carboplatin plus placebo
干预措施: Gemcitabine combined with carboplatin plus placebo (Drug)
结局指标
主要结局
progression-free survival (PFS)
时间窗: 36 months
The interval from the date of randomization until the first date on which progression, or death due to any cause
次要结局
未报告次要终点
研究者
Zhong-yu Yuan
Clinical Professor
Sun Yat-sen University