NCT00461773终止2 期
Randomized Phase II Study of Preoperative Letrozole (Femara) in Combination With Avastin in Hormone Receptor Positive Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Patients With Objective Tumor Response
研究概览
简要总结
The purpose of this study is to evaluate the objective response rate of a combination of letrozole (Femara) and bevacizumab (Avastin) given preoperatively to postmenopausal patients with hormone sensitive breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed operable or potentially operable invasive breast adenocarcinoma that is clinically palpable and measurable
- •Age ≥ 18 years
- •Clinical Stage T2-4, N0-3, M0 (Stage II-III)
- •Postmenopausal defined as Age ≥ 60 years and/or Age >45 years with amenorrhea 12 months with an intact uterus and/or History of bilateral oophorectomy and/or FSH and estradiol levels in postmenopausal range
- •ECOG PS 0, 1
- •Unifocal disease
- •ER and/or PR positive
- •Adequate hematological, renal, and hepatic functions Absolute neutrophil count ≥ 1,500/µL Platelet count ≥ 100,000/µL creatinine ≤ 1.5 mg/dL Serum total bilirubin ≤ 1.5 mg/dL Alkaline phosphatase ≤ 3X the ULN for the reference lab SGOT/SGPT ≤ 3X the ULN for the reference lab
- •Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial
- •Use of effective means of contraception (men and women) in subjects of child-bearing potential
排除标准
- •Prior history of and/or therapy for invasive breast cancer (includes chemotherapy, radiation, hormonal therapy including AIs, tamoxifen, raloxifene, fulvestrant or any other antiestrogen/SERM)
- •Clinically significant cardiovascular disease, EF <50%
- •Known CNS disease
- •History of deep vein thrombosis or pulmonary embolism
- •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).
- •Presence of non-healing wound or fracture
- •Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
- •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 (see Appendix E)
- •History of myocardial infarction or unstable angina within 12 months prior to study enrollment
- •Any history of stroke or transient ischemic attack at any time
- •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 Day 0
- •Core biopsy or other minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
- •Pregnant (positive pregnancy test) or lactating. Use of effective means of contraception (men and women) in subjects of child-bearing potential is mandatory
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- •Known hypersensitivity to any component of bevacizumab or letrozole
- •Inability to comply with study and/or follow-up procedures
研究组 & 干预措施
bevacizumab
Active Comparator
brief exposure bevacizumab
干预措施: Bevacizumab (Drug)
bevacizumab and letrozole
Active Comparator
brief exposure bevacizumab and letrozole
干预措施: Letrozole (Drug)
bevacizumab and letrozole
Active Comparator
brief exposure bevacizumab and letrozole
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Number of Patients With Objective Tumor Response
时间窗: Up to 18 weeks
Clinical objective tumor response with 14 weeks of Neoadjuvant Letrozole combined with Bevacizumab was assessed using the following categories: Complete Response (CR): tumor is no longer visible. Partial response (PR): ≥ 50% decrease from baseline in the product of two perpendicular diameters, no new lesions. Progressive disease (PD): ≥ 25% increase of the product of two perpendicular diameters or new lesions. Stable Disease (SD): Neither CR, PR, or PD criteria met. Clinical tumor assessment was performed at baseline and every 2 weeks until week 18 prior to definitive surgery.
次要结局
- Breast Conservation(Up to 14 weeks)
- Pathologic Complete Response(Up to 18 weeks)
- Drug Tolerability(Up to 18 weeks)
- Tumor Response With Biological Correlates(2 weeks)
- Radiographic Tumor Response(18 weeks)
研究者
研究点 (1)
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