A Multicenter, Placebo-Controlled, Phase III Trial of Standard Adjuvant Chemotherapy Plus Moxifloxacin in Operable Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 559
- 试验地点
- 1
- 主要终点
- disease-free survival (DFS)
研究概览
简要总结
The primary objective of this study is to compare disease-free survival (DFS) of patients with operable breast cancer randomised to treatment with standard adjuvant chemotherapy plus moxifloxacin or placebo.
详细描述
This is a multicenter, randomised, double-blind, placebo-controlled, phase 3 clinical trial. The main purposes of this study are to examine the efficacy and safety of standard adjuvant chemotherapy plus moxifloxacin or placebo as care for patients with operable breast cancer. This study is designed to recruit up to 520 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
- •Have provided written and signed informed consent;
- •Histologically confirmed invasive ductal carcinoma;
- •Planned to received (neo)/adjuvant chemotherapy;
- •Eastern Cooperative Oncology Group (ECOG) score of 0 to 1;
- •Normal blood routine, liver and kidney functions within 1 week before enrollment in this study;
- •Women of childbearing age have a negative serum or urinary pregnancy tests prior to enrollment in this study; Pre-menopause women are contracepted with medically acceptable methods during the study period.
- •Compliance with the study protocol.
排除标准
- •Pregnant or breast feeding;
- •Eastern Cooperative Oncology Group (ECOG) score ≥ 2;
- •Hypersensitivity to moxifloxacin or quinolones compounds;
- •Concomitant with other antitumor therapies or participating in other clinical trials;
- •Have a history of heart disease, such as arrhythmia, conduction block, S-T segment elevation, ischemic heart disease, or congenital heart disease;
- •Severe uncontrolled co-infection, or severe metabolic disorders;
- •A clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
- •Poor compliance, unwillingness or inability to follow protocol to continue the study;
- •Any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.
研究组 & 干预措施
standard adjuvant chemotherapy plus moxifloxacin
Standard adjuvant chemotherapy (Taxanes combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by taxanes) plus antibiotic (moxifloxacin)
Other Name: docetaxel 75mg/m^2, or nab-paclitaxel 260mg/m^2, IV, days 1, cycled every 21 days cyclophosphamide 1000 mg/m^2, IV, days 1, cycled every 21 days; or doxorubicin 60mg/m^2, IV, days 1, combined with cyclophosphamide 600 mg/m^2, IV, days 1, followed by docetaxel 75mg/m^2, or nab-paclitaxel 260mg/m^2, IV, days 1; plus Moxifloxacin 0.4 PO once daily days 1-5; cycled every 21 days
干预措施: standard adjuvant chemotherapy plus moxifloxacin (Drug)
standard adjuvant chemotherapy plus placebo
Standard adjuvant chemotherapy (Docetaxel combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by docetaxel) plus placebo
Other Name: docetaxel 75mg/m^2, or nab-paclitaxel 260mg/m^2, IV, days 1 cyclophosphamide 1000 mg/m^2, IV, days 1, cycled every 21 days; or doxorubicin 60mg/m^2, IV, days 1, combined with cyclophosphamide 600 mg/m^2, IV, days 1, followed by docetaxel 75mg/m^2, or nab-paclitaxel 260mg/m^2, IV, days 1; plus Placebo 0.4 PO once daily days 1-5; cycled every 21 days
干预措施: standard adjuvant chemotherapy plus placebo (Drug)
结局指标
主要结局
disease-free survival (DFS)
时间窗: 10 years
The interval from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death due to any cause
次要结局
- distant disease-free survival (DDFS)(10 years)
- overall survival (OS)(10 years)
研究者
Zhong-yu Yuan
Professor of Medicine
Sun Yat-sen University