Phase II Trial of Raf Kinase Inhibitor BAY 43-9006 as Single Oral Agent in Patients With Metastatic Breast Cancer Previously Exposed to Anthracycline and/or Taxane
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Proportion of confirmed tumor responses, graded according to RECIST criteria
研究概览
简要总结
This phase II trial is studying how well sorafenib works in treating patients with metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.
详细描述
OBJECTIVES:
I. Determine the tumor response rate in patients with metastatic breast cancer previously treated with an anthracycline- and/or taxane-containing regimen receiving sorafenib.
II. Assess the toxicity profile of this drug in these patients. III. Determine time to disease progression and survival time of patients treated with this drug.
IV. Correlate pre-treatment levels of activated ERK1/2 with tumor response in patients treated with this drug.
OUTLINE: This is a multicenter study.
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
- •Histologically or cytologically confirmed breast cancer
- •Clinical evidence of metastatic disease
- •Measurable disease
- •HER2-positive or -negative disease
- •If HER2 gene amplified or strongly positive for HER2 by immunohistochemistry, patient must have had prior treatment containing trastuzumab (Herceptin®) unless contraindicated
- •Previously treated with anthracycline- and/or taxane-containing regimen in the neoadjuvant, adjuvant, or metastatic setting
- •Candidate for first- or second-line chemotherapy for metastatic disease
- •Core block or tumor slides of the primary or metastatic tumor available
- •No known brain metastases
- •Hormone receptor status:
- •Not specified
- •Male or female
- •Performance status - ECOG 0-1
- •At least 3 months
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 8.5 g/dL
- •No evidence of bleeding diathesis
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST ≤ 3 times ULN
- •Alkaline phosphatase ≤ 3 times ULN
- •PT normal
- •PTT normal
- •INR normal
- •Creatinine ≤ 1.5 times ULN
- •Calcium normal
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No uncontrolled hypertension
- •No gastrointestinal tract disease that would preclude taking oral medication
- •No active peptic ulcer disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
- •No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other study agents
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study participation
- •No other uncontrolled illness
- •See Disease Characteristics
- •More than 4 weeks since prior immunotherapy
- •No concurrent anticancer immunotherapy
- •No concurrent bevacizumab
- •See Disease Characteristics
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •No more than 1 prior chemotherapy regimen for metastatic disease
- •No concurrent anticancer chemotherapy
- •Prior hormonal therapy in the neoadjuvant, adjuvant, or metastatic setting is allowed
- •No concurrent anticancer hormonal therapy
- 另有 16 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: sorafenib tosylate (Drug)
Arm I
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Proportion of confirmed tumor responses, graded according to RECIST criteria
时间窗: Up to 5 years
A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. The tumor response rate is defined as the total number of eligible patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of eligible patients enrolled on study. A 90% confidence interval for the true response rate will be constructed using the Duffy-Santner approach.
次要结局
- Survival time(Time from registration to death, assessed up to 5 years)
- Time to progression(Time from registration to disease progression, assessed up to 5 years)
- Incidence of adverse events, graded according to the NCI-CTC version 3(Up to 5 years)