Phase II Trial of Gemzar Plus Paraplatin (Plus Herceptin in HER2+ Patients) in Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Overall Tumor Response
研究概览
简要总结
The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the treatment will stop the growth of the cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of metastatic breast cancer
- •Able to visit the doctor's office at least every 14 days during the actual treatment
- •Able to care for yourself, even if you cannot work or participate in other normal activities
- •Your blood results must be adequate for therapy.
- •If you are a female of childbearing potential and test negative for pregnancy, use a reliable method of birth control during and for three months following the last dose of study drug.
排除标准
- •Have received gemcitabine, paraplatin, or trastuzumab for your cancer.
- •Be pregnant or breastfeeding
- •Have cancer to the brain and has not been treated
- •Have another active cancer besides breast cancer
- •Have received stem cell or bone marrow transplant for hematologic (blood type) cancer
研究组 & 干预措施
HER2+
Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin.
干预措施: Gemcitabine (Drug)
HER2+
Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin.
干预措施: Carboplatin (Drug)
HER2+
Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin.
干预措施: Herceptin (Drug)
HER2- (Taxane-)
Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients).
干预措施: Gemcitabine (Drug)
HER2- (Taxane-)
Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients).
干预措施: Carboplatin (Drug)
HER2- (Taxane+)
Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-pretreated patients).
干预措施: Gemcitabine (Drug)
HER2- (Taxane+)
Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-pretreated patients).
干预措施: Carboplatin (Drug)
结局指标
主要结局
Overall Tumor Response
时间窗: baseline to disease progression/recurrence (up to 3.5 years)
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
次要结局
- Duration of Response(date of response (CR or PR) until the first date of documented progression or death from any cause (up to 3.5 years))
- Number of Patients Who Experienced Alopecia(Baseline to 3.5 years)
- Time to Disease Progression (TTP)(randomization date to the earliest date of the first documented disease progression date or the date of death if the patient dies due to study disease (up to 3.5 years))
- Percentage of Patients With Overall Survival at 1 Year and 2 Years(1 Year, 2 Years)