A Multicenter Randomized Phase III Study of Combination Treatment With Vinorelbine and Gemcitabine Versus Capecitabine Monotherapy in Metastatic Breast Cancer Patients Following Treatment Failure With the Combination of a Taxane and an Anthracycline
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 10
- 主要终点
- Time to tumor progression between the two treatment arms
研究概览
简要总结
The combination of vinorelbine and gemcitabine seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline. Capecitabine rescue monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline, also seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients. Whether the combination of vinorelbine and gemcitabine or capecitabine administration is preferable is not yet known, especially in patients with metastatic disease.
详细描述
This trial will compare the efficacy of combination treatment with Vinorelbine and Gemcitabine versus Capecitabine monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 19-75 years.
- •Performance status World Health Organization (WHO) 0-
- •Histologically confirmed breast adenocarcinoma.
- •Clinical or radiological evidence of metastatic disease that has progressed after combination treatment of a taxane and an anthracycline (Taxotere + Mitoxantrone or Taxotere + Farmorubicine).
- •Measurable disease.
- •No metastatic central nervous system (CNS) disease.
- •Less than 25% of myeloproductive bone marrow irradiated.
- •Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3).
- •Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2 mg/dl).
- •Informed consent.
排除标准
- •Pregnancy or nursing.
- •Positive pregnancy test.
- •Psychiatric illness or social situation that would preclude study compliance.
- •Other concurrent uncontrolled illness.
- •Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
研究组 & 干预措施
1
Vinorelbine/Gemcitabine (VG)
干预措施: Gemcitabine (Drug)
1
Vinorelbine/Gemcitabine (VG)
干预措施: Vinorelbine (Drug)
2
Capecitabine (Cap)
干预措施: Capecitabine (Drug)
结局指标
主要结局
Time to tumor progression between the two treatment arms
时间窗: 1 year
次要结局
- Overall survival(1 year)