Phase II Study of Gemcitabine-Paclitaxel 3-Weekly Schedule as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Best Overall Tumor Response
研究概览
简要总结
The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer.
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
- •Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.
- •Unresectable, locally recurrent breast cancer or stage IV disease.
- •Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- •Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
- •Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.
排除标准
- •Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.
- •Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- •Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- •Active infection or other serious condition.
- •Pregnant or breastfeeding.
研究组 & 干预措施
A
干预措施: gemcitabine (Drug)
A
干预措施: paclitaxel (Drug)
结局指标
主要结局
Best Overall Tumor Response
时间窗: baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
次要结局
- Time to Treatment Failure(baseline to stopping treatment)
- Progression-Free Survival(baseline to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment))
- Duration of Response(time of response to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment))
- Overall Survival Probability(baseline to date of death from any cause)