A Phase II Study of BIBW 2992 Administration in Patients With Hormone Refractory Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 5
- 主要终点
- Percentage of Progression Free Participants After 16 Weeks of Treatment
研究概览
简要总结
Progression-free rate after 16 weeks of BIBW 2992 administration in association with letrozole
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
- 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
BIBW 2992
To study BIBW 2992 in association with letrozole in hormonoresistant metastatic breast cancer
干预措施: BIBW 2992 (Drug)
BIBW 2992
To study BIBW 2992 in association with letrozole in hormonoresistant metastatic breast cancer
干预措施: Letrozole (Drug)
Letrozole
Hormonotherapy for metastatic breast cancer
干预措施: BIBW 2992 (Drug)
Letrozole
Hormonotherapy for metastatic breast cancer
干预措施: Letrozole (Drug)
结局指标
主要结局
Percentage of Progression Free Participants After 16 Weeks of Treatment
时间窗: 16 weeks
Progression was defined according to 1 of the following criteria: New bone lesion(s) on bone scan or on magnetic resonance imaging; Progression or occurrence of new lesion(s) according to the Response Evaluation Criteria In Solid Tumours version 1.0 (RECIST); an increase in tumour marker CA 15.3 of more than 20 percent,compared with baseline, at 2 consecutive examinations; occurrence of disease-related skeletal events. If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD.
次要结局
- Number of Participants With Confirmed Objective Response (OR)(Baseline till progression)
- Number of Participants With Clinical Benefit (CB)(16 weeks and 24 weeks)
- Time to RECIST Tumour Reponse(Baseline till progression)
- Duration of Confirmed OR(First occurence or OR till progression or death)
- Progression-free Survival (PFS)(Baseline till progression, death or data cut-off (04 Jan 2010))
- Overall Survival (OS)(Baseline till progression, death or data cut-off)
- Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)(0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing)
- Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)(0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing)
- Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 57 (Cpre,ss,57)(Day 57)
- Pre-dose Concentration of Afatinib in Plasma at Steady Stateon Day 85 (Cpre,ss,85)(Day 85)
- Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)(0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing)
- Area Under Curve of Letrozole Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)(0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing)
- Maximum Concentration of Letrozole in Plasma at Steady State (Cmax,ss)(0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing)
- Time From Dosing to the Maximum Concentration of Letrozole in Plasma at Steady State (Tmax,ss)(0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing)
- Change From Baseline in Ca15.3(baseline and day 29)
- Best Change From Baseline in ECOG Performance Status(baseline till end of treatment)