NCT01380808已完成2 期
A Phase II Study of Capecitabine and Pseudomonas Aeruginosa Combination in the Salvage Treatment of Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
The progression free survival could be prolonged adding pseudomonas aeruginosa to monotherapy capecitabine.
详细描述
the efficacy of the combination is much better than monotherapy
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 between 18 and 70 years old
- •Patients with histologic proved metastatic breast cancer, unsuitable to be treated locally.
- •Patients with Her-2 negative breast cancer(HER-2 negative or one plus by IHC test , if HER-2 two plus by IHC,FISH result should be negative)
- •Disease progression after anthracycline and/or taxane regimen therapy and candidate for capecitabine monotherapy
- •Patients previously treated by capecitabine containing regimen should response to the chemotherapy containing capecitabine and progressed at least 4 months after the last capecitabine treatment
- •Karnofsky score more than 70；ECOG 0~2；
- •Normal functions with heart, liver,renal and bone marrow
- •WBC≥4×109/L；Hb≥90 g/L；plt≥100×109/L
- •Got ICF before enrollment
排除标准
- •Pregnant or breast-feeding women or positive serum pregnancy test
- •Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling
- •Participation in any investigational drug study within 4 weeks preceding treatment start.
- •Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer.
- •Serious uncontrolled intercurrent infections
- •Poor compliance
研究组 & 干预措施
experimental arm
Experimental
capecitabine and pseudomonas aeruginosa combination
干预措施: capecitabine and pseudomonas aeruginosa combination (Drug)
结局指标
主要结局
progression free survival
时间窗: 1 year
次要结局
- overall response rate(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Sequential Chemotherapy With Xelox Follows by TX to Treat Gastric CancerGastric CancerNCT01331928Taipei Veterans General Hospital, Taiwan51
撤回
2 期
CAPEcitabine eXtension of Adjuvant Therapy for Pancreatic Adenocarcinoma: (CAPE-X)Pancreas CancerPancreas AdenocarcinomaNCT06110598Case Comprehensive Cancer Center
已完成
2 期
Ph II Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation & or ChemoHead and Neck CancerNCT00258310Barbara Ann Karmanos Cancer Institute35
Unknown
2 期
A Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Maintenance Treatment With Capecitabine Plus Cetuximab in Metastatic Colorectal CancerColorectal NeoplasmsNCT02717923Huazhong University of Science and Technology50
已完成
2 期
Phase II Trial of Capecitabine With Fulvestrant for Postmenopausal Women With Hormone Receptor Positive Metastatic Breast CancerMetastatic Breast CancerNCT00534417Accelerated Community Oncology Research Network41