NCT00472693已完成2 期
A Phase II Trial of Bevacizumab and ABI-007 (Abraxane) as Second-line Therapy in Her-2 Negative, Hormone Receptor Negative Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- To determine progression-free survival among women receiving bevacizumab + ABI-007 given as second-line combination therapy for hormone receptive negative, Her-2 negative metastatic breast cancer.
研究概览
简要总结
The purpose of this study is to determine whether the addition of bevacizumab to Abraxane as second-line therapy in Her-2 negative, hormone receptor negative metastatic breast cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged 18 years or older and able to give informed consent.
- •Histologically- or cytologically-proven adenocarcinoma of the breast at time of first diagnosis
- •ECOG performance status 0 or 1
- •Life expectancy > 12 weeks
- •Stage IV disease and have at least one lesion measurable by standard RECIST criteria
- •Disease progression after at least one prior chemotherapy regimen for metastatic disease or within 12 months of adjuvant chemotherapy initiation.
- •All chemotherapy must be stopped > 2 weeks before enrollment.
- •Primary or metastatic tumor must be negative for estrogen and progesterone receptor expression. Testing must be done in a CLIA-approved laboratory.
- •Primary or metastatic tumor must have 0 or 1+ staining for HER2/neu identified immunohistochemically (IHC), by an approved method using one of the standard monoclonal or polyclonal antibodies (HercepTest, cb-11, PAb1, or TAB250), or if FISH status is known, it must be negative. Testing must be done in a CLIA-approved laboratory.
- •Left ventricular ejection fraction must be >= institutional lower limit of normal as determined by MUGA or echocardiogram
- •Patient must be able to comply with treatment and follow-up procedures:
- •Adequate bone marrow, liver and renal function; Absolute neutrophil count >= 1500/mm3; Hemoglobin >= 10 g/dl; Platelet count >= 100,000/mm3; Creatinine <= 2.0; PTT and either INR or PT < 1.5x normal; Total bilirubin <= 1.5 X upper limit of normal; AST, ALT, and alkaline phosphatase <= 2 X upper limit of normal (or <= 5X upper limit of normal if known liver metastases)
- •If female is of childbearing potential, pregnancy test must be negative and patient must be willing to use effective contraception while on treatment and for at least 3 months after the last dose of study medication
排除标准
- •Prior treatment with VEGF targeted therapy
- •Prior taxane therapy for metastatic disease or for adjuvant therapy within the previous 12 months
- •History of prior cancer, excluding carcinoma in situ of the cervix and non-melanoma skin cancers
- •Known CNS disease
- •Inadequately controlled hypertension (defined as systolic blood pressure>150 and/or diastolic blood pressure>100 mmHg on antihypertensive medications)
- •Any prior history of hypertensive crisis or hypertensive encephalopathy
- •New York Heart Association (NYHA) Grade II or greater congestive heart failure
- •History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- •History of stroke or transient ischemic attack within 6 months prior to study enrollment
- •Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- •Symptomatic peripheral vascular disease
- •Evidence of bleeding diathesis or coagulopathy
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- •Serious, non-healing wound, ulcer or bone fracture
- •Proteinuria at screening as demonstrated by either: Urine protein:creatinine (UPC) ratio >1.0 at screening OR Urine dipstick for proteinuria >2+ (patients discovered to have >2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate <1g of protein in 24 hours to be eligible)
- •Patients with active infection
- •Women who are pregnant or lactating
- •Radiation therapy within 3 weeks of study entry
- •Patients with hypersensitivity to ABI-007, Chinese hamster ovary cell products, or other recombinant human antibodies
- •Baseline neuropathy > grade 2
- •Participation in an investigational study of an antineoplastic agent within 4 weeks of first infusion of this study.
研究组 & 干预措施
Bevacizumab and ABI-007 (Abraxane)
Experimental
Bevacizumab and ABI-007 (Abraxane)
干预措施: Bevacizumab, Abraxane (Drug)
结局指标
主要结局
To determine progression-free survival among women receiving bevacizumab + ABI-007 given as second-line combination therapy for hormone receptive negative, Her-2 negative metastatic breast cancer.
时间窗: Study Completion
次要结局
- To determine the toxicity of bevacizumab + ABI-007 in this study population.(Study completion)
- To determine the overall response rate to bevacizumab + ABI-007 in this study population.(Study completion)
研究者
研究点 (1)
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