Randomized Phase II Study of Two Doses of Pixantrone in Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 229
- 主要终点
- Proportion of Confirmed Tumor Responses (Complete or Partial Response)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as pixantrone dimaleate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pixantrone dimaleate in different ways may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well pixantrone dimaleate works in treating patients with HER2-negative metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- To assess the proportion of confirmed tumor responses at each dose level of pixantrone
Secondary
- To describe the distribution of progression-free survival (PFS) times of patients receiving pixantrone
- To assess the 6-month PFS rate in patients receiving each dose level of pixantrone
- To describe the overall survival distribution of patients receiving pixantrone
- To assess the adverse event profile of pixantrone in the treatment of patients with metastatic breast cancer.
- To evaluate the quality of life and patient-reported symptoms of patients receiving the study regimen
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
干预措施: pixantrone dimaleate (Drug)
Arm II
Patients receive pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
干预措施: pixantrone dimaleate (Drug)
结局指标
主要结局
Proportion of Confirmed Tumor Responses (Complete or Partial Response)
时间窗: Up to 5 years
The proportion of confirmed responses will be estimated by the number of women who achieve a CR or PR on two consecutive evaluations at least 6-8 weeks apart depending on the dose level. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients at each dose level. Confidence intervals for the true success proportion at each dose level will be calculated according to the approach of Duffy and Santner. Response will be evaluated in this study using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1); Complete Response (CR): Disappearance of all non-nodal target lesions, each target lymph node must have reduction in short axis to \<1.0 cm. and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axis of the target lymph nodes taking as reference the Baseline Sum of Diameters.
次要结局
- Time to Disease Progression(Up to 5 years)
- 6-month Progression-free Survival Rate(At 6 months)
- Overall Survival Time(Up to 5 years)
- Duration of Response(Up to 5 years)
- Toxicity(Up to 1 year after treatment)