Phase II Trial of Weekly Gemcitabine and Herceptin in the Treatment of Patients With HER-2 Overexpressing Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the clinical activity of the combination of gemcitabine administered with trastuzumab represents an exciting and ideal combination to further evaluate in Her 2 over-expressing metastatic breast cancer patients.
详细描述
Upon determination of eligibility, all patients will be receive:
Gemcitabine + Trastuzumab
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •To be included in this study, you must meet the following criteria:
- •Her-2 positive metastatic breast cancer confirmed by biopsy
- •Measurable disease
- •Able to perform activities of daily living without considerable
- •No previous chemotherapy with gemcitabine
- •No more than one prior chemotherapy regimen for metastatic breast cancer
- •Adequate bone marrow, liver and renal function
- •Normal heart function
- •Give written informed consent prior to entering this study.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Received previous treatment with gemcitabine
- •History of brain metastases
- •Serious underlying medical conditions
- •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.
研究组 & 干预措施
Intervention
All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
干预措施: Trastuzumab (Drug)
Intervention
All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 18 Months
The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Progression Free Survival (PFS)(21 Months)
- Overall Survival (OS)(24 months)