LUX-Breast 2; An Open Label, Phase II Trial of Afatinib (BIBW 2992) in Patients With Metastatic HER2-overexpressing Breast Cancer Failing HER2-targeted Treatment in the Neoadjuvant and/or Adjuvant Treatment Setting
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 27
- 主要终点
- Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1
研究概览
简要总结
The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW 2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant or adjuvant setting
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Female
- 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
Afatinib 40mg once daily (OD)
Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
干预措施: Afatinib 40mg once daily (OD) (Drug)
Paclitaxel 80 mg/m2 weekly
Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
干预措施: Paclitaxel 80 mg/m2 weekly (Drug)
Vinorelbine 25 mg/m2 weekly
Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy
干预措施: Vinorelbine 25 mg/m2 weekly (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1
时间窗: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Objective response according to RECIST v1.1. Best overall response of confirmed complete response (CR) or confirmed partial response (PR) recorded since first administration of trial medication and until the earliest of disease progression, death or start of next treatment in each part separately. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of participants with OR along with exact 95% Confidence Interval by Clopper and Pearson is presented.
次要结局
- Change From Baseline to End of Treatment in Diastolic Blood Pressure (DBP)(Baseline and End of treatment period, up to 1562 days)
- Best Overall Response According to RECIST v1.1 (Regardless of Confirmation)(From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days)
- Progression Free Survival (PFS)(From drug start date in monotherapy to 1st disease progression and drug start date in combination therapy to 2nd disease progression)
- Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP)(Baseline and End of treatment period, up to 1562 days)
- Best Overall Response According to RECIST v1.1 (With Confirmation)(From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days)
- Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values(From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days)
- Duration of Objective Response According to RECIST v1.1(From the first objective response to the time of progression or death, up to 1562 days)
- Percentage of Patients With Highest Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade of 3 or Higher(From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days)