NCT01492556Unknown2 期
A Phase II, Single-arm, Multicenter Study of Etoposide Monotherapy in Treating Patients With Recurrent or Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 14
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is to determine whether Etoposide Monotherapy is effective and safe in the treatment of recurrent or metastatic breast cancer in Chinese female patients.
详细描述
Current recommended dosage of Etoposide in treating breast cancer is 50 mg/m2 orally once a day for 21 days, repeated every 28 days. With retrospective data review, this study intends to adjust Etoposide dose to 60 mg/m2 daily for 10 days, repeated every 21 days as a cycle, to investigate the effectiveness and safety of Etoposide monotherapy in the treatment of recurrent or metastatic breast cancer in Chinese female patients.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80 years old.
- •ECOG status: 0-
- •Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer.
- •No more than three prior chemotherapies, adjuvant chemotherapy excluded.
- •Received prior anthracycline, taxane therapy.
- •At least 4 weeks from previous chemotherapy.
- •Measurable disease of >=2 cm (>=1 cm on spiral CT scan).
- •Life expectancy of ≥ 3 months.
- •Adequate organ functions:
- •Hemoglobin ≥10.0 g/dl, Absolute neutrophil count ≥1.5×10^9/L, Platelet count ≥100×10^9/L,
- •Creatinine clearance ≥60ml/min,
- •Bilirubin ≤1.5 times upper limit of normal (ULN); AKP,AST and ALT ≤2.5x ULN(≤5x ULN if due to liver metastases).
- •Signed informed consent.
- •Menopausal women or received surgical sterilization, women with children potential must not be pregnant or nursing with negative pregnancy test and willing to practice acceptable methods of birth control during the study and 3 months after the study.
排除标准
- •Pregnancy or lactation.
- •Untreated or uncontrolled CNS metastases, or with refractory psychiatric illness.
- •Prior treatment with Etoposide.
- •Other primary malignancies within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer.
- •Clinically significant heart diseases (e.g.congestive heart failure, symptomatic coronary disease, uncontrolled cardiac arrhythmia, Myocardial infarction) within the past 12 months.
- •Serious uncontrolled concurrent infection or metabolism disorder.
- •Concurrent treatment for active peptic ulcer disease or with digestive disorders.
- •Prior radiotherapy and major surgery within 3 weeks before screening.
- •Less than 4 weeks since prior investigational agents.
- •Metastases present in more than one-third whole liver.
- •Unable or unwilling to comply with the study protocol.
- •Unsuitable to participate in study, that in the opinion of the treating physician.
研究组 & 干预措施
Etoposide
Experimental
Etoposide Capsules
干预措施: Etoposide (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Up to 1 year
次要结局
- Clinical response rate(Every six weeks)
- 1-year survival rate(Up to 1 year)
- Adverse events(Subjects will be followed from date of enrollment until the date of last visit, expected up to 1 year)
- Quality of Life(Every six weeks)
研究者
Binghe Xu
Deputy Director of Department of Medical Oncology
Chinese Academy of Medical Sciences
研究点 (14)
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