Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer
2015年9月5日 更新者：Zhiyong Yu、Shandong Cancer Hospital and Institute
Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Vinorelbine Plus Gemcitabine Versus Vinorelbine Plus Cisplatin
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, 100 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 Vinorelbine 25 mg/m2 d1, 8;Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks Arm B Vinorelbine 25 mg/m2 d1, 8;Cisplatin 25 mg/m2 d1, 2,3 q 3 weeks
研究概览
研究类型
介入性
注册 (预期的)
200
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Histologically confirmed metastatic breast cancer
- All patients were required to give written informed consent
- To have received a previous treatment with anthracyclines and taxanes
- Previous radiotherapy is allowed, whenever the radiated area is not the only disease location
- At least 4 weeks since the last previous antineoplastic treatment
- Patients must have recovered from all previous toxicities
- Karnofsky Performance status >= 70%
- Adequate hematological, renal, cardiac and hepatic function
- Life expectancy of at least 12 weeks
- Patients able to comply and to receive an adequate follow-up
Exclusion Criteria:
- Only bone metastases
- Active infection
- Previous treatment with one of the study drugs
- Application of other cytotoxic chemotherapy
- Insufficient renal function (creatinine clearance < 60ml/min)
- Clinically unstable brain metastasis
- Pregnancy or lactation
- Other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin)
- Abnormal liver function (bilirubin > 2.0-fold upper normal limit (UNL); Alanine aminotransferase and aspartate aminotransferase >2.5-fold UNL). In patients with hepatic metastasis, a value of Alanine aminotransferase and aspartate aminotransferase of up to 5-fold UNL is permitted
- Males
- Second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). Previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：A
Vinorelbine 25 mg/m2 d1, 8; Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks
|
|
|
实验性的：B
Vinorelbine 25 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1,2,3 q 3 weeks
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Progression Free Survival
大体时间：Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival
大体时间：Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
|
|
Clinical Benefit Rate
大体时间：Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
|
|
Duration of response
大体时间：Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
|
|
Incidence of Treatment-Emergent Adverse Events
大体时间：Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
Safety of treatment will be evaluated by the frequency of adverse events and serious adverse events, clinically significant abnormal laboratory tests, vital signs, and Eastern Cooperative Oncology Group(ECOG)performance status(PS).
All patients who received at least one dose of study treatment will be included in the safety analysis.
|
Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Xinzhao Wang, MD、Shandong Cancer Hospital and Institute
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年9月1日
初级完成 (预期的)
2017年8月1日
研究注册日期
首次提交
2015年8月22日
首先提交符合 QC 标准的
2015年9月5日
首次发布 (估计)
2015年9月9日
研究记录更新
最后更新发布 (估计)
2015年9月9日
上次提交的符合 QC 标准的更新
2015年9月5日
最后验证
2015年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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