NCT00193076已完成2 期
A Phase II Trial of Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Overall response rates
研究概览
简要总结
Pre-clinical data suggests that combination therapy with gemcitabine and carboplatin is synergistic, and both drugs may be synergistic with trastuzumab. Additionally, recent clinical data suggest that the combination of gemcitabine with platinum is an active regimen in metastatic breast cancer. This study will test the combination of gemcitabine with carboplatin in patients with metastatic breast cancer. Patients with Her2/neu overexpression will be stratified to receive trastuzumab in addition to gemcitabine and carboplatin.
详细描述
Upon determination of eligibility, all patients will receive the following treatment:
Gemcitabine + Carboplatin
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To be included in this study, you must meet the following criteria:
- •Locally advanced or metastatic breast cancer
- •Measurable disease as per RECIST criteria
- •No prior chemotherapy in the metastatic breast setting
- •Prior chemotherapy and/or hormonal therapy for early stage breast cancer
- •Adjuvant Herceptin is allowed
- •Prior radiation therapy in either the metastatic or early stage setting
- •Patients may have received any number of hormonal therapies
- •Age >18 years
- •Only women are eligible for the study
- •Able to perform activities of daily living with minimal assistance
- •Normal organ and bone marrow function
- •Patients who will be receiving Trastuzumab must have normal heart function
- •Sign a written informed consent document
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Received prior chemotherapy for metastatic breast cancer
- •Known leptomeningeal carcinomatosis
- •Uncontrolled brain metastasis
- •Uncontrolled intercurrent illness
- •Pregnant or lactating
- •History of other non-breast cancer malignancy
- •Received prior chemotherapy for early stage breast cancer within 6 months
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
Overall response rates
时间窗: 18 Months
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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