NCT00403988终止2 期
A Clinical Phase II Study of Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
Study Objective :
To assess the efficacy and the safety of the combination of Oxaliplatin, and Vinorelbine with or without Trastuzumab as a salvage regimen in patients with Metastatic Breast Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Metastatic, histologically or cytologically proven breast cancer.
- •At least one bi-dimensionally measurable lesion.
- •Previous treatment with chemotherapy as first line for metastatic disease is mandatory especially with anthracyclines +/- the Taxanes.
- •Treatment as adjuvant is allowed.
- •World Health Organization-ECOG performance status 0-
- •Adequate renal function (Creatinine <= 1.4 or Creatinine clearance >= 30 ml/min)
- •Adequate hepatic function (Liver Function Tests not more than 3 times the normal values)
- •Adequate bone marrow reserve is required (Neutrophils (PMN) >= 2000/mm2 and Platelets >= 100,000/mm2)
- •Patient who will receive Herceptin should have an over-expression of HER2-neu.
排除标准
- •Symptomatic peripheral neuropathy (National Cancer Institute common toxicity criteria grade more than one).
- •Pregnant or breast-feeding.
- •History of prior malignancies (with the exception of excised cervical carcinoma-in-situ or non-melanoma cell skin carcinoma).
- •Receiving or had received, any treatment with experimental drugs.
- •Had known brain or leptomeningeal involvement.
- •Had a serious medical condition like congestive heart failure or an Ejection Fraction ≥ 40 %.
- •The presence of bone as a sole site of metastasis.
- •Radiation therapy to all areas of measurable disease less than four weeks before treatment.
- •Creatinine two times above the normal range
- •Hypercalcemia
- •Evaluable but not a measurable disease as a sole site of metastasis: pleural effusion - Ascites - Pericardial effusion.
- •Concomitant steroid intake for > 4 weeks
- •Bilirubin two times above the normal range
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
overall response rate
时间窗: During the Study Conduct
time to progression (TTP).
时间窗: during the study conduct
次要结局
- survival(During the study conduct)
- tolerance(During the study conduct)
- toxicity.(During the study conduct)
研究者
研究点 (1)
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