NCT02443467已完成不适用
A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 主要终点
- Percentage of participants with adverse events
研究概览
简要总结
This was an open-labeled, multi-center, prospective, non-comparative study of the safety of Herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who had previously received antracycline therapy before or after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 > or = 18 years of age
- •Human Epidermal Growth Factor Receptor 2 (HER2)-neu overexpression
- •Previously treated with adjuvant antracycline containing chemotherapy
- •Left Ventricular Ejection Fraction (LVEF) > 50%
- •Eastern Cooperative Oncology Group (ECOG) score < or = 2
- •Life expectancy > or = 12 weeks
排除标准
- •Left Ventricular Ejection Fraction (LVEF) < 50%
- •Advanced pulmonary disease
- •Severe dyspnea
- •Abnormal laboratory results within 14 days prior to registration
- •Peripheral neuropathy
- •Presence of Central Nervous System (CNS) metastasis
结局指标
主要结局
Percentage of participants with adverse events
时间窗: Up to 3 years
Percentage of participants with serious adverse events
时间窗: Up to 3 years
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-Invasive LipolysisNon-invasive LipolysisNCT04878172Cynosure, Inc.9
招募中
1 期
A Study of TFX05-01 in Patients With Advanced Solid TumorsAdvanced Solid TumorNCT05434299Shenzhen Yangli Pharmaceutical Technology Co., Ltd36
终止
2 期
A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast CancerBreast CancerNCT01363986Hoffmann-La Roche3
已完成
1 期
Safety and Pharmacokinetics of CMX001 in Impaired Hepatic Function and Healthy SubjectsHepatic ImpairmentNCT05391724Chimerix25
终止
不适用
Histological Study on Safety and Efficacy of a RF Device Flexible Applicator for Non-Invasive LipolysisLipolysisNCT04881175Cynosure, Inc.3