Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
This is a phase II,single center,prospective, single arm clinical trial. The objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced Breast Cancer whose evaluation is stable disease with a trend of progression.
详细描述
This is a phase II,single center,prospective, single arm clinical trial. A lot of in vitro and in vivo study demonstrate that quinolones antibiotics can increase anti-tumor effect. The objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced Breast Cancer whose evaluation is stable disease with a trend of progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Female ≥ 18 years, ≤70 years.
- •Has measurable metastatic MBC, with at least 1 measurable lesion per RECIST criteria.
- •Fail first-line or above anti-tumor treatment
- •Evaluation is stable disease with a trend of progression.
- •Minimum life expectancy 16 weeks
- •Histological confirmation of breast cancer on primary tumour at diagnosis/on biopsy of metastasis
- •ECOG Performance Status (PS) 0-2 with no deterioration over previous 2 weeks
- •Normal organ function.
- •Has signed a Patient Informed Consent Form
排除标准
- •Hypersensitivity to moxifloxacin or other quinolones.
- •Tendon damage,peripheral neuropathy,myasthenia gravis.
- •Rapidly progressive visceral disease not suitable for further therapy.
- •Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV
- •With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment
- •Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent
- •Inability or unwillingness to comply with study procedures, including inability to take regular oral medication
- •Researchers consider it is not suitable for participation.
研究组 & 干预措施
routine therapy plus moxifloxacin
Routine therapy (chemotherapy, endocrine therapy or target therapy) is according to physician's choice.
干预措施: Moxifloxacin Hydrochloride 400mg Tablet (Drug)
结局指标
主要结局
progression-free survival (PFS)
时间窗: 1years
the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause
次要结局
- objective response rate (ORR)(6 months)
- clinical benefit rate (CBR)(6 months)
- overal survival(OS)(3 years)
研究者
Zhong-yu Yuan
MD
Sun Yat-sen University