Phase II Trial of Brostallicin and Cisplatin in Patients With Metastatic Triple Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 262
- 主要终点
- 3-month Progression-free Survival (3-mo PFS) Rate
研究概览
简要总结
This phase II trial studies how well brostallicin and cisplatin work in treating patients with breast cancer that has spread to other parts of the body (metastatic) and does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 (HER2) on its cells (triple-negative). Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from spreading.
详细描述
PRIMARY OBJECTIVES:
I. To identify any clinical efficacy of brostallicin and cisplatin in the treatment of breast cancer patients having a triple negative (estrogen receptor [ER]/progesterone receptor [PR]/HER2 negative) phenotype, as measured by progression-free survival (PFS) at 3 months.
SECONDARY OBJECTIVES:
I. To describe the confirmed tumor response rate of patients with measurable disease receiving brostallicin and cisplatin.
II. To describe the duration of response in patients with measurable disease receiving brostallicin and cisplatin.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment (cisplatin and brostallicin)
Patients receive cisplatin IV over 2 hours on day 1 and brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: brostallicin (Drug)
Treatment (cisplatin and brostallicin)
Patients receive cisplatin IV over 2 hours on day 1 and brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: cisplatin (Drug)
结局指标
主要结局
3-month Progression-free Survival (3-mo PFS) Rate
时间窗: 3 months
A patient is considered to be a 3-month progression-free survivor if the patient is on study treatment 3 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients and 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If some patients are lost to follow-up not having been observed for at least 3 months, an estimate and confidence interval for the 3-month PFS rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
次要结局
- Duration of Response(Up to 5 years)
- 6-month Progression-free Survival (6-mo PFS) Rate(At 6 months)
- Time to Disease Progression(up to 5 years)
- Survival Time(Up to 5 years)
- Confirmed Response Rate(Up to 5 years)