A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- The Number of Participants With Central Nervous System (CNS) Best Overall Response
研究概览
简要总结
Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
single arm
750 mg lapatinib administered orally twice daily
干预措施: lapatinib (Drug)
结局指标
主要结局
The Number of Participants With Central Nervous System (CNS) Best Overall Response
时间窗: time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Summary of CNS Objective Response (Lapatinib Monotherapy - MITT Population) Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer. The primary indicator of drug efficacy was CNS objective response rate. A CNS objective response was defined as either a Complete response (CR) or Partial response (PR), as assessed by volumetric analysis of brain Magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of Neurological signs and symptoms (NSS) A CNS objective response rate was defined as a 50% volumetric reduction in sum of CNS target lesions, with no new or progressive CNS or non-CNS lesions, no increases in tumor-related steroid requirements and no worsening of neurological signs or symptoms
The Percentage of Participants With Central Nervous System (CNS) Objective Response Rate - Response Rate (CR + PR)
时间窗: time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Summary of CNS Objective Response (the Complete Response + Partial Response)
次要结局
- Percentage of Participants With Improvement in Neurological Signs and Symptoms (NSS) Measured Using the Neurological Examination Worksheet(time from baseline to data cutoff (25 Sept 2007); approximately 2 years)
- Summary of Site of First Progression(time from baseline to data cutoff (25 Sept 2007); approximately 2 years)
- Time to Progression (TTP) at Any Site(time from baseline to data cutoff (25 Sept 2007); approximately 2 years)
- Overall Survival (OS)(time from baseline to data cutoff (25 Sept 2007); approximately 2 years)
- Percentage of Subjects With a CNS Objective Response or Improvement in Baseline Neurological Signs and Symptoms (NSS)(baseline and weeks 8, 16, 24, 32, 40, 48)
- Percentage of Patients With CNS Disease Control (Complete Response, Partial Response or Stable Disease) at 6 Months of Lapatinib Therapy(from Start of lapatinib to 6 months)
- Primary Cause of Death(time from baseline to data cutoff (25 Sept 2007); approximately 2 years)
- Duration of Central Nervous System (CNS) Objective Response(time from baseline to data cutoff (25 Sept 2007); approximately 2 years)