Phase II Trial of VEGF Trap in Patients With Metastatic Breast Cancer Previously Treated With Anthracycline and/or Taxane
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Proportion of Patients With Confirmed Tumor Response
研究概览
简要总结
This phase II trial is studying how well VEGF Trap works in treating patients with metastatic breast cancer. VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor
详细描述
PRIMARY OBJECTIVES:
I. Assess the antitumor activity of VEGF Trap, in terms of tumor response rate, in patients with metastatic breast cancer who have received =< 2 prior chemotherapy regimens for metastatic disease, including a taxane and/or anthracycline.
II. Assess the 6-month progression-free survival rate in patients treated with VEGF Trap.
SECONDARY OBJECTIVES:
I. Describe the adverse event profile (grade using the NCI CTCAE version 3.0) of VEGF Trap in these patients.
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 adenocarcinoma of the breast
- •Clinical evidence of metastatic disease
- •No more than 2 prior chemotherapy regimens for metastatic disease
- •Prior neoadjuvant or adjuvant chemotherapy allowed*
- •At least 1 prior regimen (in any setting) must have included a taxane and/or an anthracycline
- •Measurable disease, defined as ≥ 1 lesion whose longest diameter can be accurately measured per RECIST criteria
- •No nonmeasurable disease, defined as all other lesions, including small lesions(longest diameter < 20 mm) and truly nonmeasurable lesions, including the following:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Inflammatory breast disease
- •Lymphangitis cutis/pulmonis
- •Abdominal masses that are not confirmed and followed by imaging techniques
- •Cystic lesions
- •Patients with HER2-positive tumors (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization [FISH]) must have received ≥ 1 prior trastuzumab (Herceptin®)-containing regimen in either the adjuvant or metastatic setting, unless there was a contraindication
- •No known CNS metastases
- •No evidence of leptomeningeal involvement
- •Hormone receptor status not specified
- •Male or female
- •Menopausal status not specified
- •ECOG performance status 0-1
- •Life expectancy > 3 months
- •WBC ≥ 3,000/mm³
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 75,000/mm³
- •Hemoglobin > 8.0 g/dL
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 3 times ULN
- •AST and ALT ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Urine protein:creatinine ratio < 1 OR urine protein < 500 mg by 24-hour urine collection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- •No significant traumatic injury within the past 4 weeks
- •No history of allergy or hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies, drug product excipients, or agents chemically or biologically similar to VEGF Trap
- •No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
- •No nonhealing wound, fracture, or ulcer
- •No stage III or IV invasive, nonbreast malignancy within the past 5 years
- •No history of lung carcinoma of squamous cell type
- •No clinically significant cardiovascular disease, including any of the following:
- •Cerebrovascular accident or stroke within the past 6 months
- •Uncontrolled hypertension, defined as blood pressure (BP) > 150/100 mm Hg OR systolic BP > 180 mm Hg if diastolic blood pressure < 90 mm Hg on ≥ 2 separate occasions within the past 3 months
- •Myocardial infarction, coronary artery bypass graft, or unstable angina within the past 6 months
- •New York Heart Association class III or IV cardiovascular disease
- •Serious cardiac arrhythmia requiring medication
- •Peripheral vascular disease ≥ grade 2 within the past 6 months
- •Pulmonary embolism, deep vein thrombosis, or other thromboembolic event within the past 6 months
- •No evidence of bleeding diathesis or uncontrolled coagulopathy
- •No active, unresolved infection
- 另有 19 项未显示
排除标准
- 未提供
结局指标
主要结局
Proportion of Patients With Confirmed Tumor Response
时间窗: Up to 5 years
Confirmed tumor response was defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria on 2 consecutive evaluations at least 8 weeks apart.
Proportion of Patients Receiving Vascular Endothelial Growth Factor (VEGF) Trap With 6-month Progression-free Survival
时间窗: 6 months
The 6-month progression free survival rate was defined as the proportion of efficacy-evaluable patients on study treatment and progression-free 6 months from registration. Patients who died without documentation of progression will be considered to have progressed on the date of their death.
次要结局
- Number of Participant With Previous Treatment of Anti-HER2 With Cardiac Events(Up to 5 years)
- Progression Free Survival(Time from registration to disease progression or death (up to 5 years))
- Overall Survival(Time from registration to death or last follow up (up to 5 years))
- Median Duration of Response(Up to 5 years)