NCT00480597已完成2 期
Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Gemcitabine Plus Vinorelbine Versus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Capecitabine
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 141
- 主要终点
- Response rate
研究概览
简要总结
Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.
For each randomisation arm, 47 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective.
Study Design:
Arm A Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks
Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks
Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks
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
- 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
- •Histologically confirmed metastatic breast cancer
- •All patients were required to give written informed consent
- •Only one prior chemotherapy for metastatic breast cancer was allowed. This clinical trial was designed to test the efficacy of a second-line chemotherapy.
- •Antracycline-pretreatment during aduvant or palliative first line therapy
- •Bidimensionally measurable lesion outside a previous radiation field.
- •Age >= 18 years
- •Karnofsky Performance status >= 70%
- •Adequate heamatological, renal, cardiac and hepatic function
- •No radiation of the measurable lesion during the study was allowed.
排除标准
- •Only bone metastases
- •Active infection
- •Previous treatment with one of the study drugs
- •Application of other cytotoxic chemotherapy
- •Insufficent renal function (creatinine clearance < 60ml/min)
- •Known DPD deficiency
- •clinically unstable brain metastasis
- •pregancy or lactation
- •other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin).
结局指标
主要结局
Response rate
时间窗: one year after last patient in
次要结局
- Time to progression(one year after last patient in)
- Overall Survival(one year after last patient in)
- Toxicity
研究者
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