NCT00440622终止3 期
A Multicenter Randomized Phase III Study of Gemcitabine Plus Herceptin Combination Versus the Capecitabine Plus Herceptin Combination in Pretreated Patients With HER-2 Positive Metastatic Breast Cancer
Hellenic Oncology Research Group9 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2003年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 90
- 试验地点
- 9
- 主要终点
- Time to progression (TTP) between the two treatment arms
研究概览
简要总结
The optimal treatment for pretreated patients with metastatic breast cancer has not been established. Gemcitabine and capecitabine are two active agents in this setting. For women with Her-2 positive breast cancer, combinations of either gemcitabine or capecitabine (Xeloda) plus Herceptin has been proved active and well tolerated.
详细描述
This trial compares the efficacy of the combinations gemcitabine plus Herceptin versus capecitabine (Xeloda) plus Herceptin in pretreated patients with metastatic HER-2 positive breast cancer.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
- •HER-2 overexpression 2+ or 3+ using IHC or FISH +
- •Measurable disease
- •At least one prior chemotherapy regimen
- •Not in a prior irradiation field
- •No patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
- •No more than 25% of myeloproductive bone marrow irradiated. More than 4 weeks since prior radiotherapy and recovered
- •Age 18 - 75 year old
- •Performance status (WHO) 0-2
- •Life expectancy more than 12 weeks
- •Absolute neutrophil count > 1500/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
- •Adequate liver (bilirubin < 2 mg/dL, SGOT/SGPT < 2 times upper limit of normal, ALP < 3 times upper limit of normal, creatinine < 1.5 upper limit of normal
- •Adequate cardiac function (LVEF > 50%)
排除标准
- •Pregnant or nursing
- •Positive pregnancy test
- •Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
- •Motor or sensory neuropathy > grade 1 according to NCIC toxicity criteria
- •History of allergic reaction attributed to docetaxel
- •Psychiatric illness or social situation that would preclude study compliance
- •Other concurrent uncontrolled illness
- •Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ
研究组 & 干预措施
1
Experimental
GHer
干预措施: Gemcitabine (Drug)
1
Experimental
GHer
干预措施: Herceptin (Drug)
2
Experimental
CapHer
干预措施: Herceptin (Drug)
2
Experimental
CapHer
干预措施: Capecitabine (Xeloda) (Drug)
结局指标
主要结局
Time to progression (TTP) between the two treatment arms
时间窗: 1 year
次要结局
- Overall survival(1 year)
- Toxicity profile(During the time of chemotherpy)
研究者
研究点 (9)
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