NCT00062686已完成2 期
An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving HERCEPTIN-Containing Regimens
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Tumor response rate
研究概览
简要总结
This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.
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
- •Signed Informed Consent.
- •Histologically confirmed Stage IIIb or IV breast cancer.
- •Refractory breast cancer defined as progression in the metastatic setting after prior therapy with anthracyclines, taxanes and capecitibine.
- •Subjects with documented ErbB2 tumor overexpression must have received at least 6 cycles of trastuzumab.
- •Documented disease progression of the most recent treatment is required.
- •Archived tumor tissue available for testing.
- •Measurable lesions according to Response Evaluation Criteria In Solid Tumors (RECIST).
- •At least 3 weeks since prior cancer therapies except for trastuzumab which must be discontinued at least 2 weeks prior to the beginning of study drug.
- •Bisphosphonate therapy initiated prior to study entry is allowed, however, initiation of bisphosphonates following study entry is not allowed.
- •Able to swallow and retain oral medication.
- •Cardiac ejection fraction within the institutional normal range as measured by echocardiogram or MUGA (Multiple Gated Acquisition) scan.
- •Adequate kidney and liver function.
- •Adequate bone marrow function.
排除标准
- •Pregnant or lactating.
- •Copies of nadir scans and/or photographs of the tumor prior to disease progression as well as scans documenting disease progression are not available for review.
- •Malabsorption syndrome, ulcerative colitis, disease significantly affecting gastrointestinal function or resection of the stomach or small bowel.
- •History of other malignancy.
- •Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
- •Active or uncontrolled infection.
- •Known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure.
- •Known history of or clinical evidence of leptomeningeal carcinomatosis.
- •Active infection.
- •Concurrent cancer therapy or investigational therapy.
- •Use of oral or IV steroids.
- •Unresolved or unstable serious toxicity from prior therapy.
- •Prior treatment with an ErbB1 and/or ERbB2 inhibitor other than trastuzumab.
结局指标
主要结局
Tumor response rate
次要结局
- clinical benefit rate time to progression 4 and 6 month progression free survival overall survival
研究者
研究点 (8)
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