NCT00436709Unknown不适用
A Pilot Study of Bevacizumab With Dose Dense Doxorubicin and Cyclophosphamide (AC) Followed by Dose Dense Nanoparticle Albumin Bound Paclitaxel for the Treatment of Early Stage Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This clinical trial is studying the side effects and how well giving bevacizumab together with doxorubicin and cyclophosphamide followed by paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab works in treating patients who have undergone surgery for early-stage breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the cardiac safety of adjuvant concurrent bevacizumab and dose-dense doxorubicin hydrochloride and cyclophosphamide followed by dose-dense paclitaxel albumin-stabilized nanoparticle formulation and maintenance therapy comprising bevacizumab alone in patients with early-stage breast cancer.
Secondary
- Determine the noncardiac toxicity of this regimen in these patients.
- Determine the efficacy of this regimen, in terms of time to tumor recurrence and overall survival, in these patients.
- Explore changes in circulating endothelial cells and circulating tumor cells from pre-treatment levels in patients with no evidence of disease.
- Prospectively explore the use of serial troponin I as a predictor of cardiac toxicity in patients treated with this regimen.
- Prospectively explore the relationship between plasma renin activity and hypertension in patients treated with bevacizumab and chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed invasive breast cancer meeting the following criteria:
- •Early-stage disease
- •No stage IV disease
- •More than one synchronous primary breast tumor
- •Lymph node positive OR high-risk lymph node negative
- •Candidate for treatment with anthracycline- and taxane-based chemotherapy in the adjuvant setting
- •Must begin therapy within 84 days after the final required surgical procedure
- •HER2/neu-negative breast cancer, defined as an immunohistochemistry (IHC) score of 0, 1+ or 2+ and fluorescent in situ hybridization (FISH) not amplified
- •No CNS disease (e.g., primary brain tumor or brain metastasis)
- •Hormone receptor status known
- •PATIENT CHARACTERISTICS:
- •Male or female
- •Pre- or post-menopausal
- •ECOG performance status 0-1
- •Absolute neutrophil count ≥ 1,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin normal
- •AST or ALT ≤ 2.5 times upper limit of normal
- •Creatinine normal OR creatinine clearance ≥ 60 mL/min
- •Urine protein:creatinine ratio ≤ 1.0
- •PT and PTT normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- •LVEF normal by MUGA scan at baseline
- •No significant bleeding within the past 6 months
- •No uncontrolled underlying bleeding diathesis
- •No nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude study therapy, including any of the following conditions:
- •Blood pressure > 150/100 mm Hg
- •Unstable angina
- •New York Heart Association class II -IV congestive heart failure
- •Myocardial infarction or stroke within the past 12 months
- •Clinically significant peripheral vascular disease
- •No seizures not controlled with standard medical therapy
- •No history of stroke
- •No known allergy or hypersensitivity to study drugs (prior hypersensitivity to paclitaxel allowed)
- •No significant traumatic injury within the past 28 days
- •No serious nonhealing wound, ulcer, or bone fracture
- •No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- •No active gastroduodenal ulcer
- •No uncontrolled intercurrent illness, including psychiatric illness or social situation that would limit compliance with study requirements
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Prior therapy for an ipsilateral or contralateral breast cancer primary allowed provided the following criteria are met:
- •No prior anthracycline therapy
- •Prior hormonal therapy for this previous breast cancer is allowed, but must be stopped during study therapy
- •At least 1 year since prior taxane therapy
- •More than 28 days since prior and no concurrent major surgery or open biopsy
- •Anticipated reconstructive surgery (e.g., tissue expander exchange) is allowed during the course of the study (bevacizumab will be held during that time as per protocol guidelines)
- 另有 7 项未显示
排除标准
- 未提供
结局指标
主要结局
Safety
次要结局
- Noncardiac toxicity
- Time to tumor recurrence
- Overall survival
研究者
研究点 (1)
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