A Single Arm, Multi-Center, International, Continuation Trial of Recombinant Humanized Antibody Herceptin (Trastuzumab) in Patients With HER2-Overexpressing Tumors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 69
- 主要终点
- On-Study Duration of Trial Treatment
研究概览
简要总结
This study is designed to provide continued access to intravenous (IV) Herceptin and to evaluate long-term outcomes and overall safety in participants with stable disease and human epidermal growth factor 2 (HER2)-overexpressing metastatic or locally advanced cancer who have completed a prior study with IV Herceptin.
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
- •Ongoing participants from any completed global Roche-sponsored Herceptin trial
- •Participants enrolled in any Roche-sponsored Herceptin trial who have at least stable disease (or whose disease has not recurred) during Herceptin therapy at the end of the lead-in trial
- •Available study termination data (including tumor assessment and laboratory data) on the Case Report Form for the lead-in trial
- •Judged eligible by the investigator following a thorough risk/benefit assessment, if signs of chronic heart failure developed during the lead-in trial
排除标准
- •Pregnant or nursing women
- •Women of childbearing potential unless using effective contraception as determined by the investigator
- •Severe dyspnea at rest requiring supplementary oxygen therapy
- •Severe uncontrolled systemic disease
研究组 & 干预措施
Herceptin
Participants with stable disease and HER2-overexpressing metastatic or locally advanced cancer will receive expanded access to IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment.
干预措施: Herceptin (Drug)
结局指标
主要结局
On-Study Duration of Trial Treatment
时间窗: From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)
Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%)
时间窗: From date of enrollment until disease progression, death, or premature withdrawal; assessed per investigator discretion (maximum 7.4 years of follow-up)
Number of Participants Withdrawn From Study Because of LVEF Dysfunction
时间窗: From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)
LVEF dysfunction was defined as low LVEF measured on two consecutive assessments, with the second assessment performed after 3 weeks of study medication being withheld. Low LVEF included values less than or equal to 39% or values between 40% and 45% (inclusive) with a decrease of 10 or more percentage points from Baseline.
次要结局
未报告次要终点